MDR 2017/745: The EU's Framework for Safe and Effective Medical Devices

The European Union’s (EU) rules for medical devices changed a lot with Regulation (EU) 2017/745¹. This new rule replaced old laws and sets up a strong, clear, and lasting way to check on medical devices¹. It aims to make sure devices are safe and work well, and to help new ideas in the medical device field¹.

Contents

The MDR makes sure all medical devices and their parts follow the same rules in the EU, making it easier to move goods around¹. Important parts like checking on bodies that make sure devices are safe, testing, and watching for problems have gotten stronger to keep patients safe and make sure devices are good quality¹. It also looks at advice from groups like the Global Harmonization Task Force to make rules the same all over the world and make trade easier¹.

Key Takeaways

Regulation (EU) 2017/745 on medical devices (MDR) replaced previous directives and aims to ensure a high level of safety and health for patients and users.
The MDR harmonizes rules for placing medical devices and accessories on the EU market, facilitating free movement of goods.
Key regulatory elements, such as notified body supervision and conformity assessment, have been significantly reinforced to enhance patient safety and product quality.
The regulation takes into account international guidance to promote global convergence of regulations and facilitate trade.
The MDR is applicable to all medical devices, except in vitro diagnostic devices.

Introduction to the New EU Medical Device Regulations

Regulation (EU) 2017/745 on medical devices (MDR) was adopted to make sure medical devices are safe and innovative². It’s much bigger than the old EU Medical Device Directive (MDD). It focuses a lot on safety, with “safety” mentioned 290 times².

Background and Objectives

In March 2023, the EU made changes to the MDR and another regulation, affecting some medical devices³. These changes aim to make rules for medical devices the same across the EU².

Scope and Key Changes

The MDR covers more types of products than before². It brings in stricter rules for oversight, clinical tests, and making devices safer³. Now, devices need a unique ID to be sold in the EU².

There are 22 new rules for classifying devices, which might mean some devices need to be reclassified². The MDR also has 23 new safety and performance rules².

The MDR has been gradually put into action, with the European Commission offering guidance and Q&A³. They’ve published documents on how to follow the MDR and IVDR, including on device IDs and classification³.

Key Changes in the MDR	Description
Strengthened Oversight of Notified Bodies	Notified bodies now have more duties, like checking on devices after they’re sold and reviewing technical documents².
Enhanced Clinical Evaluation and Investigations	Now, every medical device must have solid clinical proof to show it’s safe².
Increased Transparency and Traceability	Devices must have a Unique Device Identification (UDI) to make them easier to track².

Harmonized Regulatory Framework for Medical Devices

The European Union’s Medical Device Regulation (MDR) 2017/745 sets a unified rule for medical devices in the EU⁴. It makes sure the market works well and keeps patients safe. It also helps with new medical device innovations⁴.

The MDR merges old rules like 90/35, 93/42, 98/79, and 2000/70 into one⁵. This makes the rules clearer and keeps medical devices standards the same everywhere in the EU⁵.

Devices are now sorted into four classes: Class I, IIA, IIB, and III⁵. The rules get stricter as the risk level goes up. This means high-risk devices get checked more closely⁴.

The MDR makes notified bodies more important⁵. They check and approve medical devices before they hit the market⁵. These bodies work with each country’s authorities to keep medical devices safe and effective⁵.

The MDR’s unified rules boost patient safety and encourage new ideas⁴⁵. It helps medical devices move freely within the European Union⁴⁵.

Enhancing Patient Safety and Product Quality

The Medical Devices Regulation (MDR) aims to boost patient safety and quality. Manufacturers must now do thorough clinical tests and investigations. This ensures medical devices are safe and work well⁶. The rule also makes post-market checks and vigilance stronger to keep an eye on device safety and how they perform⁷.

Clinical Evaluation and Investigations

Under the MDR, makers must share detailed info on how devices work, including clinical trials and reports on bad events⁶. This means they need to do careful clinical tests and studies to prove devices are safe and work as they should before selling them⁶. Big names like Johnson & Johnson focus on managing risks and work with health pros and patients to make sure devices are super safe⁶.

Post-Market Surveillance and Vigilance

The MDR also makes rules for better watching over medical devices after they’re sold. Agencies come out with new or updated rules every 13 minutes on average, showing how important it is to keep watching⁷. New tech like AI helps check on devices automatically, cutting down time, costs, and mistakes in watching over them⁷. Having a good system for watching over devices after they’re sold is key for keeping them safe, following the rules, and making healthcare better worldwide⁷.

“Neglecting safety in medical device design can lead to adverse events, patient harm, and lawsuits.”

The MDR’s focus on making sure devices are safe and work well is key for better healthcare. It helps patients and health workers a lot⁶.

Promoting Innovation in Medical Device Technology

The medical device industry is diverse and innovative, with over 7,000 firms making more than 1,700 types of medical products⁸. It’s all about innovation, putting about 7.5% of sales back into research and development (R&D)⁸. The number of patents for medical devices is rising, showing the industry’s growth in technology⁸.

The EU’s Medical Device Regulation (MDR) supports innovation in medical technology. It sets clear rules and makes sure devices are safe and effective. The FDA’s CDRH Innovation initiative also helps by offering support, programs, and communication tools for manufacturers and payors. Learn more about the FDA’s CDRH Innovation.

But, getting a new device to market can be tough. It costs about $73 million on average, and the PMA path is often more expensive than the 510(k) process⁹. Delays can also add a lot of cost, with a year’s delay adding $10 million⁹.

To help, the EU and agencies like the FDA support innovators. They offer help, funding, and ways for companies to work together. These efforts aim to make new medical devices available to patients and grow the innovation in the field.

Metric	Value
Medical Device Firms in the US	6,007
Firms with Fewer Than 20 Employees	3,725
Firms with More Than 500 Employees	150

The industry’s focus on innovation is clear in the second edition of “Promoting Access to Medical Technologies and Innovation”. This report by the WHO, WIPO, and WTO is a detailed look at how we can improve access to medical technologies¹⁰.

“Incremental technology innovation brought through the 510(k) process does not necessarily equate to incremental clinical value; transformational leaps are usually created through a series of small steps.”⁹

medical device innovation

The EU and agencies are working to make it easier for innovators in medical technology. They offer support, funding, and help with challenges. Their goal is to make sure patients get the latest medical devices and improve healthcare outcomes.

Transparency and Traceability Requirements

The EU’s Medical Device Regulation (MDR) 2017/745 brings new rules to make medical devices more transparent and traceable. A key part of this is the UDI system¹¹. This system gives each medical device a unique ID. This ID helps link devices to their makers for better tracking, recalling products, and reporting issues¹¹.

Unique Device Identification (UDI) System

The UDI system makes it easier to identify and track medical devices throughout their life¹¹. It’s a must for software that acts as a medical device (SaMD) under FDA rules¹¹. In some cases, the FDA may order tracking for devices linked to serious health problems or long-term use. This means manufacturers must track devices to the patient level and follow strict audit rules¹¹.

Good traceability helps companies keep track of their product parts, follow rules, manage risks, and keep the supply chain smooth¹¹.

Key Traceability Data Elements	Description
Traceability Lot Code (TLC)	An alphanumeric descriptor used to uniquely identify a traceability lot within a firm’s records¹².
Critical Tracking Events (CTEs)	The key events in the supply chain that must be recorded, such as harvesting, cooling, initial packing, first land-based receiving, shipping, receiving, and transformation of food¹².
Traceability Plan	Detailed procedures for record-keeping, identifying foods, assigning traceability lot codes, providing a point of contact for queries, and submitting farm maps¹².

The UDI system and other traceability steps under the MDR aim to better identify devices, improve tracking after they’re sold, and make recalling faulty products easier¹¹¹³. This will help make medical devices safer and of better quality for patients¹¹.

Roles and Responsibilities of Economic Operators

The EU Medical Device Regulation (MDR) clearly outlines the roles and duties of economic operators in the medical device supply chain. These include manufacturers, authorized representatives, importers, and distributors. This framework ensures accountability and transparency from design to distribution and beyond¹⁴.

Under the MDR, four legal entities are seen as economic operators: Manufacturers, Importers, Distributors, and Authorized representatives¹⁴. Each has clear duties, like keeping records, reporting, and handling products in the EU market¹⁴.

The supply chain’s complexity can vary, with several importers and distributors possible¹⁴. If a manufacturer is in the EU, there might be three operators: the maker and two distributors¹⁴. But if the manufacturer is outside the EU, more operators like an authorized representative and an importer might be needed¹⁴.

Economic Operator	Key Responsibilities
Manufacturer	EUDAMED registration, technical documentation, assembly, distribution, corrective actions, complaints management, post-market surveillance¹⁵
Authorized Representative	Maintain technical documentation, conduct documentation checks, provide audit support, ensure compliance¹⁵
Importer	Verify product labeling, ensure compliance with maintenance conditions, check instructions for use¹⁵
Distributor	Ensure CE marking, provide unique device identifiers, manage device recalls, report nonconformity¹⁵

Efforts to streamline the supply chain can include fewer distributors, one importer, and centralizing activities like repackaging and translation. This simplifies MDR compliance¹⁴. Keeping track of progress and being open is key for economic operators in the supply chain¹⁴.

The Person Responsible for Regulatory Compliance (PRRC) is key under the MDR. They need at least one year of experience in Quality Management Systems for medical devices, a relevant certification, and knowledge of the medical device field¹⁵. Following the MDR is vital for economic operators in the EU medical device industry to avoid legal issues and keep operating in the European market¹⁵.

Transparency and monitoring of progress are crucial in ensuring compliance among economic operators in the supply chain¹⁴.

The MDR also brings new rules for medical device manufacturers exporting to the United Kingdom and Switzerland¹⁶. Manufacturers must follow EU, UK, and Swiss laws, with checks by importers, authorized representatives, Responsible Persons, and distributors¹⁶.

Conformity Assessment and Notified Bodies

The Medical Device Regulation (MDR 2017/745) makes sure notified bodies check medical devices before they hit the market¹⁷. It also makes the designation process for these bodies stricter. This ensures they are up to the task of checking devices¹⁷.

Strengthened Oversight and Designation Process

Notified Bodies (NBs) are chosen under the Medical Device Regulation (MDR 2017/745) to check medical devices for CE marking before they enter the European market¹⁷. The countries in Europe where these bodies are located make sure they have the right setup, quality management, and resources¹⁷.

NBs do conformity assessment activities using different methods. This includes checking quality management systems, testing products, reviewing technical files, and more¹⁷. They face challenges that are talked about to help manufacturers and distributors get ready for CE-marking¹⁷.

The European Parliament and Council made rules for medical devices and in vitro diagnostic medical devices to manage conformity assessment and Notified Bodies¹⁷. The European Commission offers tools like EUDAMED and NANDO to help with checking devices and making sure they meet standards¹⁷.

New tech in the medical device field is facing hurdles because of the Medical Device Regulation¹⁷. The new rules for medical devices in Europe might change things and bring new challenges for makers¹⁷.

In the European Economic Area (EEA), medical devices don’t need approval like medicines do before they can be sold¹⁸. But, makers must say their product meets the law to put the CE mark on it and sell it in the EEA¹⁸.

Checking if medical devices meet standards involves picking the right modules based on the risk they pose¹⁸. Notified bodies often help with this checking. They are chosen and watched over by groups like the Central Authority of the Laender for Health Protection in Germany¹⁸.

Devices are put into risk classes like I, IIa, IIb, and III based on how much harm they could cause¹⁸. If a device is in a higher risk class, it usually needs a notified body to check it¹⁸.

Clinical tests are needed to show that devices are safe and work well in real use¹⁸. Until May 25, 2022, in vitro diagnostics (IVDs) followed the In Vitro Diagnostics Directive and were sorted into risk classes¹⁸.

IVDs are put into risk classes A to D under a new rule, and the riskier ones need a notified body to check them¹⁸. To prove safety and performance, IVDs go through performance studies using clinical data or samples from people¹⁸.

There are special rules for putting devices on the market without full checks in emergencies like the COVID-19 pandemic¹⁸.

“The new European Regulation for medical devices is expected to bring changes affecting innovation and creating new challenges for manufacturers in the industry.”

Medical Device Regulation Implementation Timelines

The European Union’s Medical Device Regulation (MDR) has been a big step forward. It aims to make medical devices safer and encourage innovation¹⁹. Since 1976, the rules for medical devices in the EU have changed a lot. Now, there’s better tracking of devices after they’re sold, fees for users, and faster reviews for new devices¹⁹.

Switching to the new MDR has been tough, so the rules have been extended²⁰. Now, high-risk devices have until 2027 and lower-risk ones until 2028 to meet the new standards²⁰. This change has made industry leaders and experts happy. They were worried about running out of devices if the deadline was kept²⁰.

The MDR’s new timeline is because of the COVID-19 pandemic, material shortages, and the workload of Notified Bodies (NBs)²⁰. This change will help avoid problems with medical devices in the European Union.

Year	Regulatory Development
1976	Introduction of a three-class, risk-based classification system for all medical devices in the United States¹⁹.
1990	Implementation of improved postmarket surveillance of medical devices through requiring user facilities to report adverse events and authorizing the FDA to require manufacturers to perform postmarket surveillance¹⁹.
2002	Enactment of the Medical Device User Fee and Modernization Act (MDUFMA), granting the FDA authority to collect user fees for select medical device premarket submissions¹⁹.
2007	Requirement for all registration and listing of medical devices to be performed electronically by the FDA in the United States¹⁹.
2012	Creation of a direct De Novo pathway for novel, low-to-moderate risk devices permitting classification into Class I or II without a 510(k) submission¹⁹.
2016	Introduction of the 21st Century Cures Act, mandating the creation of policies to expedite patient access to new medical devices including codifying the FDA’s expedited review program for breakthrough devices¹⁹.
2017	Reauthorization of the medical device user fee program (MDUFA IV), setting improved premarket review times and investments in strategic initiatives¹⁹.
2020	Enhancement of FDA’s capacity to address medical product supply chain shortages during public health emergencies through the Coronavirus Aid, Relief, and Economic Security Act (CARES Act)¹⁹.
2022	Establishment of the FDA User Fee Reauthorization Act of 2022 (FDAUFRA), reauthorizing the medical device user fee program (MDUFA V) and introducing fee adjustments based on performance goals¹⁹.
2022	Passing of the Food and Drug Omnibus Reform Act of 2022 (FDORA) which enhances oversight of device establishments and grants FDA authority to approve devices with predetermined change control plans (PCCP)¹⁹.

The MDR is a key step for the medical device industry in the European Union. It ensures devices are safe and work well. The extended deadlines help the industry adjust smoothly and keep devices available for patients.

Global Convergence and International Standards

The European Union’s Medical Device Regulation (MDR) 2017/745 pushes for global convergence of medical device rules²¹. It does this by using international guidelines, like those from the Global Harmonization Task Force (GHTF) and the International Medical Device Regulators Forum (IMDRF)²¹. This teamwork makes sure medical devices are safe everywhere and helps trade across the globe.

Groups like the IEC and ISO²¹ create important standards that help make rules the same everywhere. This makes sure people everywhere can get good healthcare without spending too much. It also encourages more research and development²¹. The International Medical Device Regulators Forum (IMDRF) helps countries work together on rules for medical devices²¹.

Working together, important groups like regulators help make international standards. This makes sure devices work the same way everywhere²¹. This teamwork is key for making medical device rules the same all over the world²¹.

International Regulatory Initiatives	Key Focus Areas
Asia-Pacific Economic Cooperation (APEC)	Promote trade and sustainable economic growth Regulatory harmonization and capacity building FDA CBER experts contributing to priority work areas
International Council for Harmonisation (ICH)	Develop harmonized guidelines for new medicines Minimize animal testing and clinical trial duplication
International Pharmaceutical Regulators Programme (IPRP)	Exchange information and cooperate on regulatory matters Create synergies and avoid duplication of effort CBER experts active in working groups
Pan American Network for Drug Regulatory Harmonization (PANDRH)	Support regulatory convergence in the Americas Strengthen capacities of National Regulatory Authorities

These efforts show the world’s commitment to regulatory convergence and harmonizing medical device standards. This teamwork makes sure people everywhere can use safe, effective, and compatible medical devices. It also helps with innovation and investment in the field²².

“The alignment with international standards and best practices contributes to a high level of safety protection worldwide and facilitates global trade in medical devices.”

Conclusion

The EU Medical Device Regulation (MDR) 2017/745 sets a strong, clear, and lasting rule for medical devices in the European Union. It makes safety, clinical checks, and tracking of devices more. This ensures patients and users are well protected. It also helps in bringing new medical device ideas to life²³.

The MDR, along with the In Vitro Diagnostic Medical Devices Regulation (IVDR), brings medical device rules in the EU up to global standards. This is a big step towards making sure all EU countries have the same rules for medical devices²³.

The MDR was made official on May 5, 2017, and started on May 26, 2017. It gave a three-year window (later extended to four years because of COVID-19) for companies to adjust and sell devices in the EU under the new rules²³. It uses a life-cycle approach to ensure safety, supported by data. Devices are put into four risk classes: I (lowest risk), IIa, IIb, and III (highest risk)²³.

The MDR’s new rules make sure devices are safe by making them more transparent and traceable. This affects how medical devices get certified²³.

With the global medical device market over £110 billion a year, and the European market growing by 5-8% annually, the MDR is key to improving patient safety and boosting innovation in medical devices²⁴.

FAQ

What is the purpose of the EU’s new Medical Device Regulation (MDR) 2017/745?

The MDR sets up a strong, clear, and lasting rule for medical devices in the European Union. It makes sure devices are safe and protect health, while also encouraging new ideas in the medical device field.

What are the key changes introduced by the MDR compared to the previous directives?

The MDR brings in tighter control over notified bodies, better clinical checks, and more openness and tracking. It also requires a Unique Device Identification (UDI) system for better tracking.

How does the MDR ensure patient safety and product quality?

The MDR makes clinical checks and investigations stricter. It also requires thorough clinical evaluations. The rule has stronger checks after devices hit the market to keep an eye on their safety and how well they work.

How does the MDR support innovation in medical device technology?

The MDR creates a stable and predictable rule book. This helps make it easier to bring out new and creative medical devices.

What are the key requirements for economic operators under the MDR?

The MDR clearly spells out what different companies in the medical device chain must do. This includes manufacturers, reps, importers, and distributors. It makes sure everyone is clear about their roles and responsible throughout a device’s life.

How does the MDR strengthen the conformity assessment and oversight of notified bodies?

The MDR makes sure notified bodies are checked more closely before they can check devices. It also makes the process of getting a device on the market stricter. This ensures these bodies are up to the task and trustworthy.

What are the implementation timelines for the MDR?

The MDR took full effect on May 26, 2021, replacing old rules. It allows for a grace period so devices that meet old rules can still be sold in the EU.

How does the MDR align with international standards and best practices?

The MDR works towards global rules for medical devices, using international advice like from the GHTF and IMDRF. This makes sure devices are safe everywhere and helps with trade across borders.