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Spencer al Congresso Anpas Emergenza

54° Congresso Nazionale Anpas

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Spencer al REAS 2022

We are glad to be the official sponsor of the 54° National Congress for ANPAS, the Italian council that represents public EMS associations around Italy.
Spencer support of this event demonstrates our commitment to the EMS world in Italy, as well as our need to listen to paramedics feedback, understand their need and develop solutions that make them work more efficiently and safely.
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Tanexpo 2024

Antonio Ciardella appointed as CEO of Protect Medical

Antonio Ciardella named as CEO of Protect Medical

Sicur 2024

Arab Health 2024

10 Key Changes Introduced by the New EU Medical Device Regulation

Unveiling the latest innovations in the EMS field

Masterclass Dubai 2023

Are your facilities safe for everybody?

We are now working with a new ERP: Microsoft Dynamics 365 Business Central

New Company Information System

The International Leading Exhibition for Rescue and Mobility

RETTMobil 2023

After the acquisiton of Söhngen, Spencer and Promeba, Protect Medical completes the take over of PAX.

PAX joins Protect Medical

Arab Health 2023

Intersec 2023

EMS World Expo 2022

International Exhibition for Rescue, Fire Fighting, Disaster Relief and Security


R.E.A.S. 2022

Fill this form to book a meeting with us at the event.

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Spencer at Tanexpo

Spencer will participate in Tanexpo

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We are excited to announce Spencer Italy&#8217;s participation in <a href="https://www.tanexpo.com/it/la-fiera">TANEXPO</a>, the leading international exhibition for professionals in the funeral industry, which will take place in Bologna from April 4th to 6th. Find us in Hall 16 at booth A51-B52, where we&#8217;ll be delighted to demonstrate our latest industry innovations.

 SPENCER AT TANEXPO 2024

TANEXPO is renowned as the premier platform for showcasing the latest trends and innovations in the funeral sector. For Spencer Italy, this biennial event provides an invaluable opportunity to affirm our dedication to innovation and our commitment to developing <a href="https://www.spencer.it/en/emergency-rescue-equipment/coffin-handling-equipment">advanced technologies</a> that enhance professional standards and offer value-added services to funeral homes, cemeteries, and morgue units.
Presenting our products at TANEXPO, which harmonize efficiency, safety, and aesthetics, actively contributes to the advancement of the funeral industry. We introduce modern, considerate approaches tailored to the operational needs and sensitivities of our partners and their clientele.

WHY VISIT US AT TANEXPO?

Building on the successes of 2021 and 2022, we approach TANEXPO with renewed vigor. &#8220;Our presence at this exhibition reaffirms Spencer Italy&#8217;s commitment to the funeral sector,&#8221; states Gennaro Pinto, our Mortuary Product Specialist.
This year, we&#8217;re excited to present a major breakthrough: the expansion of our group with the integration of subsidiaries <a href="http://promeba.com/">Promeba</a> and <a href="https://www.pax-bags.com/en">Pax</a>. These strategic alliances enable us to augment the motorization of our offerings and further modernize our product line.
We will showcase technical enhancements to our foldable trolleys, Z501/Z503, and their motorized counterparts, <a href="https://www.spencer.it/en/emergency-rescue-equipment/coffin-handling-equipment/power-z501">Power Z501</a> and <a href="https://www.spencer.it/en/emergency-rescue-equipment/coffin-handling-equipment/power-jack-e">Power Jack-E</a>. Additionally, we&#8217;ll introduce an innovative motorized stretcher, a result of our collaboration with Promeba, designed to revolutionize the industry by reducing the physical burden on operators.

INNOVATIVE EQUIPMENT FOR THE FUNERAL INDUSTRY

Our booth at TANEXPO will be dynamic and interactive, featuring hands-on demonstrations that highlight the benefits of motorized operations. &#8220;We aim for operators to directly experience the advantages of our motorized stretchers and trolleys, pioneering solutions that mitigate injury risks and substantially enhance the quality of the working environment,&#8221; Pinto elaborates.
The powered mechanism behind our Z501 trolley, the Power Z501, represents a significant leap in reducing manual labor during funeral services. This innovation simplifies challenging tasks, like transporting coffins, making them more manageable through the use of an electric motor and a battery-operated remote control.

EMBRACING MOTORIZATION: A NEW OPERATIONAL PHILOSOPHY

Our leadership in the market is underpinned by our investment in technology and our commitment to authentic Made in Italy manufacturing. Renowned for their outstanding durability and low maintenance costs, our products are designed to support funeral industry professionals with innovative, superior-quality solutions.
We cordially invite you to visit us at TANEXPO 2024 on April 4 to 6, booth A51-B52, to discover how our innovative solutions can revolutionize your daily operations in the funeral sector. Join us as we explore the future of the industry together.

LOOKING TO THE FUTURE

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Antonio Ciardella CEO

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In the fast-paced world of Emergency Medical Services (EMS), leadership transcends mere resource management—it's about catalyzing change and propelling innovation. Antonio Ciardella, stepping in as the new CEO of Protect Medical, perfectly exemplifies this ethos as he assumes leadership, poised to steer the company towards new frontiers.

ANTONIO CIARDELLA NAMED CEO OF PROTECT MEDICAL

LEADING PROTECT MEDICAL INTO A NEW ERA OF INNOVATION AND GROWTH

Antonio Ciardella&#8217;s journey in the medical industry, starting from the high-pressure front lines of emergency response in Italy, showcases his unwavering dedication and profound expertise. As a leader of a first responders department, Mr. Ciardella did more than just fulfill his duties; he built a deep understanding of the EMS sector, weaving a broad tapestry of industry insights and connections.
His front-line experience served as a crucible, shaping his strategic and visionary leadership abilities and facilitating a seamless transition to corporate leadership roles in the late 1990s. Ciardella&#8217;s career has been characterized by relentless growth and notable achievements, with his ascent to corporate leadership emerging as a natural extension of his expanding skill set and forward-thinking mindset.

The Journey of Mr. Ciardella: From the Front Lines to Strategic Leadership

Joining Spencer as Sales Director in the early 2000s, Mr. Ciardella was the linchpin in the company&#8217;s ambitious international expansion, playing a crucial role in winning significant projects and tenders globally.
His visionary leadership and strategic acumen were key in securing Spencer&#8217;s dominance in the EMS market across Asia, South America, and Europe. Through his innovative approach and deep understanding of the market, Mr. Ciardella not only set new benchmarks for success in the industry but also established Spencer as the standard-bearer for patient transport equipment worldwide, significantly influencing practices and expectations in EMS care.

A Track Record of Exceptional Leadership

After <a href="https://protect-medical.com/">Protect Medical</a>&#8216;s acquisition of Spencer in April 2020, Antonio Ciardella leveraged his extensive experience to enhance the group&#8217;s capabilities, assuming the role of Managing Director for both <a href="https://www.spencer.it">Spencer</a> and <a href="https://www.soehngen.com/en">Soehngen</a>. Under his leadership, the companies have not only thrived but also reinforced their market presence.
Mr. Ciardella&#8217;s strategic prowess was not only demonstrated through the flourishing of Spencer and Soehngen but also through the pivotal acquisitions of <a href="http://promeba.com/">Promeba</a> in 2022 and <a href="https://www.pax-bags.com/en">PAX-Bags</a> in 2023, which expanded our global reach and enriched our product suite. These moves underscore Protect Medical&#8217;s continued dominance in the EMS industry.
As a consequence of these significant accomplishments, Antonio Ciardella was named CEO of Protect Medical in March 2024, accompanied by Andreas Harms, who joined Protect Medical following the acquisition of PAX-Bags in the preceding year. Mr. Harms, with his deep EMS sector knowledge, complements Ciardella&#8217;s visionary leadership. Together, they embody a powerful synergy, uniting their diverse strengths to steer Protect Medical toward new frontiers of success and innovation.

A New Chapter at Protect Medical

With Antonio Ciardella and Andreas Harms leading the way, Protect Medical is poised to enter a new era characterized by innovation, growth, and strategic expansion. Their collective expertise, which combines practical field experience with strategic business insight, uniquely equips Protect Medical to continue delivering state-of-the-art solutions in the EMS, safety, and mortuary sectors.
We are thrilled to welcome Antonio Ciardella and Andreas Harms as the new leaders of Protect Medical. Their combined journey, enriched by hands-on frontline experience and strategic insight, signals a bright and promising future for our company. Together, they represent the epitome of leadership and vision, poised to steer Protect Medical to brilliant achievements.
Keep an eye on our blog for further updates and insights as we embark on this exciting journey with Antonio Ciardella and Andreas Harms at the helm.

Embarking on a New Era

Since 2020, Spencer has been an integral component of Protect Medical Holding, a group of innovative and growth-oriented global companies. This collective harnesses synergies, shares resources, and develops products with the aim of establishing itself as the premier reference in the emergency, first aid, and mortuary industries

DISCOVER PROTECT MEDICAL

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Sicur 2024 Rescue

Spencer at Sicur

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SICUR, Spain&#8217;s premier international security event, is back, and we at Spencer Srl are thrilled to announce our participation. This year, we&#8217;re not just showcasing our innovative solutions; we&#8217;re creating a wonderful experience for our visitors. Join us at booth 8B12A, where the future of security and safety unfolds.

JOIN SPENCER AT SICUR IN SPAIN: A GLIMPSE OF INNOVATION IN THE WORLD OF SECURITY AND SAFETY

<a href="https://www.ifema.es/en/sicur">SICUR</a> is more than an exhibition; it&#8217;s a glimpse into the future of security and safety, a platform where industry leaders and innovators gather to share insights and breakthroughs. At Spencer, we lead this evolution with advanced rescue and safety solutions, in collaboration with our exclusive dealer in Spain, <a href="https://prohesol.com">Prohesol</a>. Our synergy extends through the Protect Medical&#8217;s family, including <a href="https://www.pax-bags.com/en">PAX-Bags</a>, known for their high-quality emergency bags; <a href="https://www.soehngen.com/en">Soehngen</a>, specialists in first aid and medical supplies; and <a href="http://promeba.com">Promeba</a>, experts in medical and emergency equipment. Together at Sicur we&#8217;re setting new standards in safety and emergency response.

WHY VISIT US AT SICUR?

At our booth, we&#8217;re excited to showcase our state-of-the-art emergency and rescue equipment. Visitors will have the opportunity to explore:
<ul>
<li>Rescue Stretchers: Our <a href="https://www.spencer.it/en/emergency-rescue-equipment/rescue-stretchers">range of stretchers</a> is designed for a variety of rescue scenarios, ensuring safety and efficiency in decisive moments.</li>
<li>Evacuation Chairs: These <a href="https://www.spencer.it/en/emergency-rescue-equipment/evacuation-chairs">chairs</a> are essential for safe and swift evacuation from multi-story buildings, combining ease of use with comfort.</li>
<li>Transport Chairs: Focused on patient comfort and mobility, our <a href="https://www.spencer.it/en/emergency-rescue-equipment/transport-chairs">foldable stair chairs</a> are ideal for transporting the mobility impaired through narrow spaces during an emergency.</li>
<li>Immobilization Devices: Patient safety during pre-hospital transport is paramount, and our <a href="https://www.spencer.it/en/emergency-rescue-equipment/immobilization">immobilization devices</a> are crafted to provide maximum stability and support.</li>
</ul>
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Each product on display at our booth 8B12A a testament to our commitment to innovation, reliability, and safety in emergency situations.

SHOWCASING OUR PREMIUM RESCUE AND SAFETY EQUIPMENT

We&#8217;re not just about demonstrations; we&#8217;re about solutions. Visit us to discover exclusive offers and engage with our team of experts. Whether you&#8217;re interested in the latest trends or seeking advice on specific challenges, we&#8217;re here to provide insights and solutions that drive your success.
Our team of specialists looks forward to meeting with you. With expertise spanning various aspects of security and safety, we&#8217;re here to answer your questions, discuss industry trends, and explore how our solutions can benefit your organization.

MEET THE TEAM: EXCLUSIVE OFFERS AND CUSTOMIZED SOLUTIONS

The future of security and safety is here, and it&#8217;s waiting for you at SICUR. Join Spencer Srl and our partners at booth 8B12A for an unforgettable experience. Contact us to schedule an appointment. See you at SICUR!

JOIN US AT BOOTH 8B12A

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Spencer at Arab Health 2024

Emergency Arab Health Spencer

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Arab Health 2024, set at the Dubai World Trade Centre from January 29 to February 1, marks the 49th edition of the Middle East&#8217;s largest healthcare event. This year&#8217;s exhibition is a testament to the global healthcare industry&#8217;s dynamism, with over 40 country pavilions and exhibitors from 73 countries participating, making it a truly international affair.

SPENCER AT ARAB HEALTH 2024: SHOWCASING INNOVATION IN THE EMS SECTOR

We at Spencer are thrilled to be a part of this grand event, where we will be showcasing our state-of-the-art emergency medical solutions. Our booth, located at H8.F01, will feature our innovative products, each designed to enhance efficiency and safety in emergency medical situations.

SPENCER'S EXCITING PARTICIPATION

<ul>
<li>Kinetix: Our <a href="https://www.spencer.it/en/emergency-rescue-equipment/ambulance-stretchers/powered-stretchers/kinetix">powered stretcher</a> revolutionizes patient transport, capable of lifting up to 300 kg with just the push of a button.</li>
<li>Crossover: A <a href="https://www.spencer.it/en/emergency-rescue-equipment/ambulance-stretchers/multilevel-ambulance-stretchers/crossover-2">multilevel self-loading stretcher</a> with a compact design for optimal maneuverability and efficiency.</li>
<li>4Bell Stair+: This <a href="https://www.spencer.it/en/emergency-rescue-equipment/transport-chairs/4bell-stair">stair chair</a> is expertly designed for the smooth evacuation of mobility-impaired individuals.</li>
<li>PAX Vacuum Mattresses: Offering <a href="https://www.pax-bags.com/en/shop/vakuummatratze-ergo-mat/">superior immobilization</a> for trauma patients during transport.</li>
<li>PAX Wasserkuppe: <a href="https://www.pax-bags.com/de/shop/wasserkuppe-l-ft">Premium emergency backpack</a> that is synonymous with efficiency and rapid response.</li>
</ul>

WHAT WE ARE BRINGING AT ARAB HEALTH

Visiting our booth at Arab Health is more than just exploring products; it&#8217;s about discovering solutions that can be integrated into your emergency medical services. Whether you&#8217;re part of the healthcare sector or an emergency response team, our booth is the ultimate destination to see innovation in action.

WHY VISIT OUR BOOTH?

Arab Health 2024 is not just an exhibition; it&#8217;s a platform for healthcare professionals worldwide to connect, learn, and grow. We, at Spencer Italia, are excited to be part of this transformative event and look forward to meeting you at Booth H8.F01. Join us in shaping the future of emergency medical services.

CONCLUSION

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MDR Regulation

EU MDR Regulation

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Welcome to our comprehensive guide on the new EU Medical Device Regulation (MDR), Regulation (EU) 2017/745, which has replaced Directive 93/42/EEC as of May 2021. This significant regulatory shift aims to increase medical device safety and effectiveness across the European Union. Here, we explore the top 10 changes introduced by the MDR and discuss how these changes impact stakeholders in the medical device industry, including manufacturers, distributors, resellers and importers.

NEW IMPACT FOR THE MEDICAL INDUSTRIES

 10 Key Changes Introduced by the New EU MDR.

The Medical Device Regulation (<a href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745">MDR</a>) is a comprehensive legislative framework that redefines how medical devices are designed, manufactured, and distributed across the European Union. More than just a set of rules, the MDR imposes stringent requirements aimed at drastically improving transparency, traceability, and overall product reliability within the medical sector. This regulation is essential as it tackles both longstanding and emerging challenges in medical technology, such as the rapid advancement of device innovation and the integration of software as a medical device.
For stakeholders in the medical industry — manufacturers, distributors, resellers and importers — understanding and adhering to the MDR is paramount. The regulation affects nearly every aspect of the medical device lifecycle, from initial design through post-market surveillance. Compliance is not merely about legal necessity; it is critical to maintaining trust and safeguarding user health. Non-compliance could result in heavy fines, withdrawal of products from the market, and significant damage to brand reputation.
Furthermore, the MDR is designed to ensure that all devices, whether they are cutting-edge robotic surgical aids or simple diagnostic tools, undergo rigorous testing and evaluation before they reach the market. This ensures that all medical devices used within the EU are safe, effective, and of the highest quality, which in turn supports public health and maintains the integrity of the European single market.
In the following sections, we will delve into the top 10 changes introduced by the MDR, highlighting how each change impacts the roles and responsibilities of those involved in the medical device industry. This guide will provide clarity and actionable insights to help stakeholders navigate this complex regulatory environment successfully.

WHAT IS THE EU MDR

Under the new MDR, the definition of what constitutes a medical device has been significantly broadened. This includes not only traditional medical devices but also non-medical and aesthetic devices such as dermal fillers, which were not previously regulated under the older Directive. This change aims to ensure that all products that have a medical purpose meet rigorous safety standards.

1. Expanded Product Scope

The Medical Device Regulation (MDR) introduces new rules for classifying medical devices into Class I, Class IIa, Class IIb, and Class III, reflecting the level of risk associated with their intended use. This classification system is crucial because it determines the level of control necessary to ensure the safety and effectiveness of devices before they reach the market.
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<ul>
<li>Class I Devices: These are the lowest risk devices and typically include non-invasive products like bandages, patient transport equipment (<a href="https://www.spencer.it/en/emergency-rescue-equipment/ambulance-stretchers">stretchers</a>, <a href="https://www.spencer.it/en/emergency-rescue-equipment/transport-chairs">stair chairs</a>, <a href="https://www.spencer.it/en/emergency-rescue-equipment/rescue-stretchers">rescue systems</a>, <a href="https://www.spencer.it/en/emergency-rescue-equipment/immobilization">immobilization devices</a>), handheld surgical instruments, and reusable surgical retractors. Class I devices are subject to the least regulatory control and do not require a conformity assessment by a Notified Body, except when they have a measuring function or are sterile.</li>
<li>Class IIa and Class IIb Devices: Class II devices are medium risk. Class IIa devices might include dental fillings and sutures, ventilators, <a href="https://www.spencer.it/en/emergency-rescue-equipment/suction-devices">suction units</a>, whereas Class IIb are generally considered higher risk under Class II, including blood bags and infusion pumps. These devices require more stringent conformity assessments involving a Notified Body to ensure compliance with the essential requirements.</li>
<li>Class III Devices: These are the highest risk devices and include items such as heart valves, implantable defibrillators, and breast implants. Class III devices are subject to the highest level of regulatory scrutiny to ensure their safety and effectiveness. The conformity assessment for these devices includes a detailed examination of the manufacturing process and ongoing evaluations.</li>
</ul>
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Under the new MDR, the classification rules have been updated and expanded to include more detailed consideration of specific device features like whether the device is invasive or implantable, incorporates a medicinal substance, or is intended to be used for more than 30 days. These factors contribute to a more precise classification and tailored regulatory oversight.

2. Reclassification of Devices

The regulation mandates adherence to new common technical specifications set by the European Commission or a designated panel of experts. These specifications must be considered alongside existing Harmonised Standards and the current state of the art, elevating the requirements for compliance.

3. Common Technical Specifications

Under the new Medical Device Regulation (MDR), the role and responsibilities of manufacturers have been significantly expanded to ensure higher standards of safety and efficacy for medical devices within the European Union. This enhanced role requires manufacturers to undertake comprehensive measures throughout the lifecycle of each device, from design to post-market surveillance.
Manufacturers like Spencer must now demonstrate that their medical devices are designed and manufactured in accordance with the stringent requirements of the MDR. This includes proving through detailed documentation and testing that each device complies with the relevant safety and performance specifications. This obligation ensures that every device placed on the market has been rigorously evaluated for safety and efficacy, reducing the risk of adverse events and improving patient outcomes.

4. Enhanced Role of Manufacturers

Under the new Medical Device Regulation (MDR), there is an enhanced emphasis on accountability and expertise within manufacturing organizations. Manufacturers are now required to appoint at least one Qualified Person (QP) who holds the responsibility for ensuring regulatory compliance of their medical devices. This requirement underscores the importance of having skilled personnel who can manage the complex regulatory landscape effectively.
The role of the Qualified Person is pivotal in navigating the regulatory requirements set forth by the MDR. The QP is responsible for the oversight of all aspects of the quality management system, from device conception through design, manufacturing, market release, and post-market surveillance. This individual serves as a key point of contact between the manufacturer and regulatory authorities, ensuring that all communication and reporting obligations are met accurately and on time.
The MDR specifies that the Qualified Person must have formal qualifications and a minimum number of years of professional experience in the field of medical devices. The QP is also tasked with maintaining the documentation and records necessary to demonstrate compliance, such as technical documentation, declarations of conformity, and compliance with the UDI system.

5. Identification of a Qualified Person

The implementation of the Unique Device Identification (UDI) system under the new Medical Device Regulation (MDR) represents a significant advancement in the traceability and safety management of medical devices throughout the European Union. This system requires that each medical device marketed in the EU is assigned a distinct UDI, a globally unique code that accompanies the device throughout its market life. This UDI is essential for enhancing the transparency and accountability of medical devices.
The UDI itself is comprised of two parts:
<ul>
<li>the Device Identifier (DI) which denotes the specific model of the device and the manufacturer,</li>
<li>the Production Identifier (PI) which provides information related to the production of the device, such as the batch number, serial number, expiration date, and manufacturing date. This information is crucial as it helps to precisely identify and track medical devices.</li>
</ul>
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The primary benefit of the UDI system is improved traceability. Having a unique identifier for each device allows healthcare providers, patients, manufacturers, and regulatory bodies to track the device from manufacturing through to end use. This enhanced traceability is crucial not only for routine tracking but also for effectively managing critical situations such as recalls. In the event of a recall, the UDI allows for swift identification of affected devices, ensuring they can be quickly located and removed from circulation if necessary.

6. Unique Device Identification (UDI)

Under the MDR, manufacturers like Spencer are required to provide comprehensive clinical evidence for each device they intend to market. This evidence must demonstrate through clinical evaluations and, if necessary, clinical investigations, that their devices are consistently safe and perform as intended. The level of evidence required varies based on the device’s classification, with higher-risk devices subject to more stringent evaluations.
For many devices, particularly those that are new or have been significantly modified, existing clinical data may not be sufficient to meet the new standards. In such cases, we at Spencer have been required to conduct clinical investigations to gather new data. These studies are designed to assess the safety and performance of the devices in real-world medical settings, providing robust evidence that supports their market approval.
The MDR also imposes an ongoing obligation on manufacturers to regularly update their clinical evidence. This means that our organization must continuously monitor and gather data on the performance and safety of its devices post-market. This is achieved through various means, such as post-market clinical follow-up studies, customer feedback, and the monitoring of adverse event reports.

7. More Rigorous Clinical Evidence

Systematic clinical evaluation under the MDR involves a continuous and rigorous assessment process to ensure that medical devices comply with current safety and performance standards. Manufacturers are required to regularly review and update their clinical evaluations based on new scientific findings and feedback from actual device usage. This ongoing process helps identify potential safety issues and efficacy concerns, ensuring that devices remain effective and safe throughout their lifecycle. The systematic approach ensures that medical devices continue to meet the high standards expected in the ever-evolving medical field.

8. Systematic Clinical Evaluation

Under the new Medical Device Regulation (MDR), the authority of <a href="https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/notified-bodies_en">Notified Bodies </a>has been significantly strengthened to ensure the ongoing compliance and safety of medical devices after they have entered the market. These enhanced powers include the ability to conduct unannounced audits of manufacturing facilities, which serves as a powerful deterrent against non-compliance and helps maintain consistent adherence to regulatory standards. Additionally, Notified Bodies can now perform more thorough product sample checks and execute detailed testing of the devices. This level of rigorous oversight is crucial for detecting any deviations from safety standards or performance specifications that might not be apparent during the initial certification process.
The increased post-market surveillance activities by Notified Bodies help in identifying and addressing potential risks associated with medical devices at an early stage. This proactive approach ensures that any issues can be rectified promptly, thereby safeguarding public health and maintaining the trust of consumers and healthcare professionals in the safety and efficacy of medical devices available on the market.

9. Post-market Oversight

Distributors are now required to implement comprehensive quality management systems that align with the MDR’s strict standards. These systems are crucial for ensuring that all aspects of the distribution process—from storage and handling to the final delivery of medical devices—are conducted in a manner that maintains the integrity and efficacy of the products.
In addition to establishing quality management systems, distributors must also conduct regular sample inspections of the medical devices they distribute. This involves periodically selecting samples from their inventory and assessing them for compliance with regulatory standards and performance criteria. These inspections help to identify any deviations from specified quality standards or potential safety issues before the products reach healthcare providers and patients.
This heightened involvement of distributors is designed to reinforce the overall safety net of the medical device market, ensuring that all entities involved in the supply chain contribute to the continuous safety and compliance of medical devices. These measures not only protect public health but also enhance the accountability and reliability of the distribution network in the medical device industry.

10. Involvement of Distributors

<ul>
<li>26/05/2021: All Class I medical devices must comply with the MDR. Certificates issued under the old Directive can remain valid for up to four additional years, depending on the device.</li>
<li>27/05/2024: Certificates issued under the old Directive are no longer valid.</li>
<li>27/05/2025: Devices certified under the old Directive can no longer be sold or distributed.</li>
</ul>

Transition Periods and Compliance Deadlines

As a proactive manufacturer committed to compliance and excellence, Spencer has implemented comprehensive strategies to ensure that all its products fully adhere to the stringent requirements of the new Medical Device Regulation (MDR).
1. Strengthening R&amp;D Capabilities: Spencer has significantly invested in its research and development (R&amp;D) capabilities, enhancing the design and testing of its medical devices. This strategic enhancement includes the establishment of dedicated teams focused on clinical research and data analysis, ensuring that our innovations align with cutting-edge medical needs and regulatory expectations.
2. Establishing Robust Clinical Trials: To validate the safety and efficacy of our devices, Spencer conducts controlled clinical trials. These trials are meticulously designed to generate valid and reliable data, complying with both global standards and specific regulatory requirements. This rigorous approach to clinical trials ensures that our products are not only effective but also secure for patient use.
3. Enhancing Data Management Systems: Recognizing the critical role of data in proving compliance and enhancing device safety, Spencer has implemented advanced data management systems. These systems manage the extensive data collected from clinical trials and post-market surveillance, ensuring accurate recording, processing, and easy accessibility for ongoing analysis and regulatory review.
4. Continuous Training: Spencer is committed to continuous professional development, ensuring that all staff, especially those involved in regulatory processes, are well-trained in the latest requirements and clinical evaluation procedures. This includes specialized training for the Qualified Person responsible for regulatory compliance, keeping our team at the forefront of regulatory excellence.
5. Engaging with Regulatory Bodies: To maintain transparency and compliance, Spencer actively engages with regulatory authorities. This engagement includes regular pre-submission meetings and updates about ongoing clinical studies, ensuring that all clinical evaluations and documentation align with current regulatory standards.
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Through these strategic initiatives, Spencer not only ensures compliance with the new MDR but also reinforces its position as a leader in the medical device industry, dedicated to providing products that are safe, effective, and of the highest quality. This comprehensive approach not only satisfies regulatory demands but also builds trust with healthcare providers and patients, securing a safer future for medical device applications.

SPENCER'S COMPLIANCE WITH THE MDR

The new EU Medical Device Regulation (MDR) marks a pivotal transformation in the regulation of medical devices within the European Union, significantly enhancing the standards for patient safety and device effectiveness. This regulation not only impacts manufacturers but also places a new emphasis on the role of distributors, who are now required to meet more stringent compliance and oversight obligations.
Distributors are integral to the medical device supply chain, and the MDR mandates that they implement robust quality management systems and engage in meticulous sample inspections to ensure that the devices they distribute consistently meet the highest standards of safety and effectiveness. These responsibilities highlight the importance of distributors in maintaining the integrity of medical devices from the point of manufacture to delivery to healthcare providers.
The MDR&#8217;s comprehensive approach elevates the benchmarks for all stakeholders involved in the medical device lifecycle—manufacturers, distributors, and healthcare providers alike—ensuring that everyone contributes to the safety and efficacy of medical devices. This collaborative effort not only protects patients but also reinforces the quality of healthcare across Europe.
For stakeholders looking to navigate these changes or understand their specific implications, we invite you to <a href="https://www.spencer.it/en/medical-emergency-company">get in touch with us</a> for more detailed information and guidance. By choosing to partner with compliant and certified manufacturers like Spencer, distributors can assure healthcare providers and patients of their commitment to distributing top-quality medical devices, thus enhancing healthcare outcomes throughout the continent. This strategic alignment with the MDR&#8217;s standards is crucial for maintaining trust and ensuring the continued well-being of patients across the EU.
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Author: Domenico Panetta, Head of Marketing and Communication

dubai-masterclass

Dubai Masterclass

Spencer Dubai Masterclass

emergency rescue equipment

We are delighted to share the incredible success of Masterclass Dubai 2023, a workshop that exceeded expectations and set new standards in the realm of emergency and rescue solutions. Hosted by <a href="https://www.spencer.it/en">Spencer</a> and <a href="https://www.pax-bags.com/en/">PAX</a>, in collaboration with <a href="https://www.weinmann-emergency.com">Weinmann</a>, this two-day event brought together industry experts and key opinion leaders, fostering exploration, innovation and a transformative approach to the emergency response landscape.

A RESOUNDING SUCCESS SHAPING THE FUTURE OF EMERGENCY AND RESCUE SOLUTIONS

The workshop served as a dynamic platform for unveiling the latest innovations in the Emergency Medical Services (EMS) field. One standout product that garnered significant attention was the new <a href="https://www.spencer.it/en/emergency-rescue-equipment/ambulance-stretchers/powered-stretchers/kinetix" target="_new">Spencer Kinetix</a>. This powered stretcher redefines patient transport, combining cutting-edge technology with ergonomic design for efficient and secure operations for both health workers and the patient. Its intuitive control panel and adaptability to various emergency scenarios make Kinetix a game-changer in the field.
Additionally, the new <a href="https://www.spencer.it/en/emergency-rescue-equipment/transport-chairs/4bell-stair" target="_new">4Bell Stair+</a> and <a href="https://www.spencer.it/en/emergency-rescue-equipment/transport-chairs/nextep" target="_new">NEXTEP</a> transport chairs showcased at the workshop impressed attendees. The 4Bell Stair+, with its innovative design, provides a smooth and controlled descent on staircases, ensuring patient safety and ease of transport in narrow spaces. NEXTEP, on the other hand, stands out as a practical powered stair climber, designed to improve the evacuation and transport of people with mobility limitations going up or down stairs.

UNVEILING CUTTING-EDGE SOLUTIONS

Taking place in the prestigious H Hotel on the 28th and 29th of November, Masterclass Dubai fostered a vibrant atmosphere for knowledge exchange and collaboration. Attendees had the opportunity not only to witness these groundbreaking medical products in action but also to engage with experts, providing valuable feedback for further refinement and application.

KNOWLEDGE EXCHANGE AND INFORMATION

We are grateful for the diverse backgrounds and perspectives that enriched our discussions. The global insights brought by our esteemed partners have undoubtedly enhanced the adaptability and effectiveness of our emergency and rescue equipment on a worldwide scale. The collaborative spirit ignited during the workshop will undoubtedly have a lasting impact on the global emergency response community.

GLOBAL PERSPECTIVE, LOCAL IMPACT

To all contributors, speakers, and attendees, your passion and insights are the driving force behind our mission. Your active participation has contributed immensely to the success of Masterclass Dubai 2023, and we extend our heartfelt gratitude for being integral to this transformative experience.
As we reflect on the outcomes of Masterclass Dubai 2023, we look forward to the continued collaboration and the positive impact our collective efforts will have on emergency and rescue operations globally. Stay tuned for updates, as this is just the beginning of our journey together.

YOUR CONTRIBUTIONS MATTER

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Stair-Chairs-for-the-Mobility-Impaired es gallery

Stair-Chairs-for-the-Mobility-Impaired es

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Evacuation Stair Chairs for Disable People

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Facilities and workplaces featuring stairs often incorporate safety measures designed to protect and assist the evacuation of staff, visitors, and residents during emergencies. However, a critical question remains: have you adequately considered the specific needs of people with reduced mobility? 

If you find that your facility has not yet addressed these needs, it's imperative to act swiftly. Enhancing safety and inclusiveness isn't just a matter of compliance; it's a commitment to community and human dignity. We have developed reliable, user-friendly solutions that are crucial for increasing the safety and inclusiveness of your premises during emergency situations.

SKID EVACUATION STAIR CHAIRS

ARE YOUR FACILITIES SAFE FOR EVERYONE?

Emergencies in buildings and workplaces are unpredictable and can arise without warning.
In scenarios such as a fire, earthquake, explosion, or even a simple power outage, lifts become inoperative, which severely complicates the evacuation process, especially for those who are injured or have mobility impairments.
These situations demand preparedness to manage and control the aftermath effectively, ensuring the safety and well-being of all occupants. A fundamental aspect of this preparedness is inclusivity, ensuring that no one is left behind during these critical moments. Investing in tools like evacuation stair chairs not only enhances safety but also embodies the principle of inclusivity.
Our <a href="https://www.spencer.it/en/emergency-rescue-equipment/evacuation-chairs">SKID evacuation stair chairs</a>, for instance, can be deployed rapidly, transforming a potentially hazardous evacuation into a manageable, safer process.

LEAVING NO ONE BEHIND

Evacuation chairs are pivotal in creating a safer environment for everyone within a facility. By boosting your emergency preparedness, you not only provide equal opportunities for people with reduced mobility but also gain peace of mind, knowing that comprehensive safety measures are in place.
These chairs are typically installed close to staircases and can be quickly utilized to assist mobility-impaired individuals downstairs or across flat surfaces to safe assembly points. They are indispensable tools for facility and security managers, playing a crucial role in ensuring that all staff members, visitors, or customers, regardless of their physical capabilities, can be safely evacuated from multi-storey buildings during emergencies.

WHY EVACUATION CHAIRS SHOULD BE ESSENTIAL EQUIPMENT IN YOUR FACILITY

Spencer SKIDs are not merely functional; they are innovative, lightweight, and robust, designed to facilitate safe and controlled evacuations. The design incorporates rails which aid movement down stairs, providing operators with enhanced control and stability, which is crucial during emergencies. We offer three main types of SKID evacuation chairs, catering to various needs and environments:
Fitted with rails for easy movement down stairs, they offer operators greater control and stability in decisive moments:
The 3 main types of evacuation chairs SKID we manufacture are:
<ul>
<li><a href="https://www.spencer.it/en/emergency-rescue-equipment/evacuation-chairs/pro-skid-e">PRO SKID-E</a>: This model is both lightweight and durable, featuring front and rear telescopic handles that are ideal for navigating both up and down stairs.</li>
<li><a href="https://www.spencer.it/en/emergency-rescue-equipment/evacuation-chairs/skid-ok">SKID-OK</a>: Exceptionally compact, this chair weighs only 10 kg, making it ideal for tight spaces and narrow staircases. Despite its light frame, it can support up to 250 kg and comes with optional armrests for additional comfort.</li>
<li><a href="https://www.spencer.it/en/emergency-rescue-equipment/evacuation-chairs/skid-e">SKID-E</a>: Known for its high maneuverability and control, this model is economically priced without compromising on quality or functionality. The SKID-E MAX variant supports up to 250 kg, making it suitable for a wide range of individuals.</li>
</ul>

WHAT EXACTLY ARE SKID EVACUATION CHAIRS?

The installation of certified Spencer SKID stair chairs in your facility is a proactive step towards enhancing safety and mobility for all occupants, including employees, visitors, residents, and customers with disabilities. Emergencies can happen unexpectedly, and being prepared with the right equipment is crucial for a safe and smooth evacuation process.
By integrating SKID stair chairs, you not only ensure the safety of individuals during emergencies but also foster a more inclusive atmosphere in your workplace.
For more details on our range of Spencer evacuation stair chairs and how they can benefit your facility, please consult our <a href="https://cdn.spencer.it/app/uploads/2023/06/28145312/Skid-Evacuation-Chairs-Catalogue.pdf">SKID catalogue</a>.
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Author: Domenico Panetta, Head of Marketing and Communication
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START MAKING YOUR FACILITIES SAFER FOR EVERYONE

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Skid Evacuation Stair Chair

This video shows step-by-step how easy and safe it is to evacuate people with mobility limitations in multi-storey buildings. 

SKID CHAIR TRAINING VIDEO

HOW TO USE SPENCER SKID TO EVACUATE PEOPLE WITH REDUCED MOBILITY

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Galleria Preview Sito

New ERP_Newsletter

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starting from 3 July 2023 we are operating with a new ERP, Microsoft Dynamics 365 Business Central, an advanced information system that will help us to improve the efficiency of our operations by automating processes, streamlining workflows and increasing productivity.

SPENCER LAUNCHED MICROSOFT BUSINESS DYNAMICS 365

NEW ERP TO INCREASE PRODUCTIVITY AND STREAMLINE WORKFLOWS

Since Spencer became part of <a href="https://protect-medical.com/">Protect Medical GmbH</a>, we have embarked on a path of renewal that has gradually affected all our corporate operations.
We have added to our team a pool of specialists in the field of business development, communication and finance; we launched a new website and made available <a href="https://www.spencer.it/en/emergency-rescue-equipment">new equipment</a> specifically designed for the EMS, rescue and mortuary sectors.
Il nostro obiettivo, da 3 anni a questa parte, è stato di fatto quello di supportare con responsabilità la crescita globale delle nostre operations con strumenti e processi adeguati per affrontare le sfide future.
Our goal in the last 3 years has been to streamline our operations and the way we interact with our stakeholders with more comprehensive strategies and more advanced tools.
One of the most important milestones we have reached so far is the launch of the new ERP, operational since July 3, 2023: Microsoft Dynamics 365 Business Central.
Thanks to the important contribution of <a href="https://www.eos-solutions.it/it/home.html">EOS Solutions</a> and the collaboration of our IT and regulatory teams, the new ERP will become the beating heart of all our activities for years to come. It will affect all our information sharing processes, data analysis, business reporting, invoicing and supply chain tasks.

NEW COMPANY INFORMATION SYSTEM

Our company’s growth has reached a point where it is critical to process information quickly and to be as agile as possible to meet market requirements and customer needs.
As we launch Microsoft Dynamics 365 Business Central, our new ERP, we are laying the groundwork to streamline our operations, optimize efficiency and improve data accuracy. This significant step towards digitalization will soon be followed by the implementation of advanced CRM systems, that will in turn deliver faster response times and a better customer experience.

WHY LAUNCHING A NEW ERP?

We usually experience moments of change like this with enthusiasm and the firm belief that they will create new value for all of us. This approach helps us to manage any temporary slowdowns during the transition and implementation period.
We are therefore convinced that from the coming weeks onwards, patience from our partners will not be lacking.
At the same time, we at Spencer will guarantee the utmost support to explain the improvements this change brings about and will work hard to solve any temporary issue that may arise in the very short term, as we wait for the infrastructure to become fully operational.
This moment for Spencer is truly &#8220;decisive&#8221;. We are confident that, like other challenges we faced over the last 34 years, also this structural change will turn into a marked success.

READY TO FACE FUTURE CHALLENGES

FREQUENT ASKED QUESTIONS

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Spencer at RETTMobil

RETTMobil Exhibition

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RETTmobil Spencer

<a href="https://www.rettmobil-international.com/en/start-page/">RETTmobil 2013</a> will take place on May 10-12 in Fulda (Germany) and Spencer Italia will be among the key exhibitors, showcasing an impressive range of new patient handling and rescue equipment.

VISIT OUR BOOTH AT RETTMOBIL 2023

RETTmobil gathers in Fulda the main world manufacturers of mobility, rescue and PPE. Whether you are a firefighter, a paramedic, an emergency specialists or an health &amp; safety professional, you will find in one single place companies specialized in special vehicle conversion, evacuation, first aid, reanimation, immobilization and transport.
As market leaders in the production of emergency and rescue equipment, we at Spencer wish to give visitors at RETTmobil the opportunity to test and assess our new range of powered transport devices. Of course we will be also glad to reconnect with existing business partners throghout the world.

WHY ATTENDING RETTMOBIL

Spencer&#8217;s booth at RETTmobil will be located in a very accessible position for visitors: hall 7, n° 701.
Our team of experts at the stand will be pleased to offer free product demonstrations, showcasing how to use devices that have now become dominant during pre hospital transport operations.
The equipment we will have on display are:
<ul>
<li>KinetiX, the new 10G powered stretcher that loads patients into an ambulance with the push of a button.</li>
<li>Nextep, the power chair for the mobility impaired that makes stairway descent and ascent as easy as it gets, withouth causing any strain on caregivers.</li>
<li>Stark-E, the self-loading ambulance stretchers designed to offer better usability for EMS workers, thanks to its 4 telescopic handles.</li>
<li><a href="https://www.spencer.it/en/emergency-rescue-equipment/stretcher-support-systems/bob-multilevel-4">BOB Multilevel 4</a>, the easy-to-install mechanical stretcher support system, that can be set to four different levels to make it easier to load stretchers into rescue vehicles.</li>
<li><a href="https://www.spencer.it/en/emergency-rescue-equipment/rescue-stretchers/basket-stretchers/twin-shell">Twin Shell,</a> the highly-resistant basket stretcher that can be deployed in extreme scenarios. It can be divided in two for better storage.</li>
<li><a href="https://www.spencer.it/en/emergency-rescue-equipment/rescue-stretchers/patient-transport-sheet/hirvin-max">Hirvin Max</a>, the transport sheet specifically designed for recovering bariatric patients.</li>
<li><a href="https://www.spencer.it/en/emergency-rescue-equipment/evacuation-chairs/pro-skid-e-max">Pro Skid-E Max</a>, the evacuation stair chair with increased load capacity (250 kg).</li>
<li><a href="https://www.spencer.it/en/emergency-rescue-equipment/suction-devices/ambujet">Ambujet</a>, the 10G suction unit with rechargable base and shock proof shell.</li>
<li><a href="https://www.spencer.it/en/emergency-rescue-equipment/transport-chairs/4bell-stair">4Bell Stair+</a>, the ultra-light EMS chair that helps transporting patients down stairs during an emergency.</li>
</ul>
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Come and visit our stand at RETTMobil. We look forward to meeting you at booth 701, Hall 7.

WHICH EQUIPMENT WILL SPENCER SHOWCASE?

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PAX Joins Protect Medical

PAX Bags and Backpacks

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Protect Medical, the holding company for emergency medicine companies established by Borromin Capital Fund IV in June 2019, announces the acquisition of X-Cen-Tek GmbH & Co. KG (PAX), a leading provider of emergency medicine products with a focus on emergency backpacks and bags. 

Following the acquisition of Söhngen (2019), Spencer Italia (2020) and Promeba (2022), the acquisition of PAX represents another important step for Protect Medical's strategic growth and expansion plan.

NEW ACQUISITION SHAKES UP THE EMERGENCY INDUSTRY

PAX JOINS PROTECT MEDICAL

The finalization of the acquisition of PAX has stirred positive reactions from the main actors involved in the operation.
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<a href="https://www.linkedin.com/in/martin-franke-a1068a150/">Martin Franke</a>, Partner at Borromin, states: &#8220;PAX is the market leader for emergency equipment (rescue bags and backpacks) in the European market with a high level of recognition among its customers. The acquisition of PAX expands the group&#8217;s activities in terms of product range and customer base and will further strengthen the group&#8217;s market position.&#8221;
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<a href="https://www.linkedin.com/in/christoph-hirschmann-3434b088/">Christoph Hirschmann</a>, Managing Director of Protect Medical, is eager to start working with PAX&#8217;s management: &#8220;I am delighted that PAX will become part of the Protect Medical Group. The company has been on my wish list as a strategic corporate acquisition for Protect Medical for some time. With Andreas Harms (Managing Director of PAX), the group gains another experienced manager from the emergency medicine industry. We are very much looking forward to working together and expanding our product and service offering for our existing and new customers.&#8221;
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Managing Director <a href="https://www.linkedin.com/in/antonio-ciardella-79410113/" data-attribute-index="9" data-entity-type="MINI_PROFILE">Antonio Ciardella</a> has expressed his satisfaction with the deal: &#8220;With PAX part of our family, we can now add premium emergency bags and backpacks to an already impressive product porfolio. We are proud to continue to deliver high-quality equipment to first responders, paramedics and rescue workers around the world.&#8221;
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<a href="https://www.linkedin.com/in/andreas-harms-0386bb5b/">Andreas Harms</a>, Managing Director of PAX: &#8220;The combination of PAX and Protect Medical marks a milestone for both companies and is just the beginning of the success story. I look forward to working with Antonio Ciardella (Managing Director of Spencer) and Christoph Hirschmann to unlock the full potential of this partnership.&#8221;

REACTIONS FROM MAIN STAKEHOLDERS

Founderd in 2000 by Andreas Harms, <a href="https://www.pax-bags.com/en/">PAX-Bags</a> is a leading global brand specialised in the design and manufacture of premium emergency bags. backpacks and rescue transport systems. PAX products are widely considered to set the standard for quality within the EMS sector and are used by professional rescue workers and paramedics from all around the world.

WHO IS PAX?

<a href="https://www.borromin.com/en/">Borromin</a> is an independent private equity firm focused on medium-sized companies in German-speaking Europe and the Benelux countries. The private equity fund initiated and advised by Borromin investS in medium-sized companies and provide equity capital for business successions, management buy-outs and growth financing.
Borromin was founded in 2001 and has since pursued a successful, value-oriented strategy of investing in profitable companies in a wide range of industries.
Borromin Capital Fund IV (Borromin Capital Fund IV SCS, SICAV-RAIF) benefits from the financial support of the European Union under the European Fund for Strategic.

WHO IS BORROMIN?

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Arab Health Dubai

ArabHealth_2023

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The annual medical exhibition Arab Health will take place in Dubai from January 30 to February 2 and Spencer will be among the main international exhibitors.

COME AND VISIT SPENCER AT ARAB HEALTH 2023

<a href="https://www.arabhealthonline.com/en/Home.html">Arab Health</a> is the most important medical gathering in the Middle East.
In the last decade the medical industry has expanded exponentially and Arab Health has often been the opportunity for many businesses in this sector to showcase new products that have significantly improved the way paramedics and health personel deliver medical and emergency care.
Arab Health also this year has managed to attract a very great number of industry leaders from over 64 countries, including medical equipment manuacturers, orthopaedic devices suppliers, rehabilitation and mobility unit producers and so on.