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The EU’s new medical device regulatory framework brings with it significant changes to existing directives

In 2008, the European Commission initiated a public consultation on existing requirements covering medical devices, which produced more than 200 comments and proposals for change from a wide variety of stakeholders. As a result, the European Commission released in 2012 its plan to restructure the EU’s medical device regulatory framework, along with a regulation that would replace existing directives for medical devices and active implantable medical devices.

This means that manufacturers of medical devices who sell within the European Union (EU) will soon face major changes in the EU’s decades-old regulatory framework, as the Medical Device Regulation (MDR) was officially published on 5 May 2017 and came into force on 25 May 2017. The MDR will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC).

Manufacturers of currently approved medical devices will have a transition time of three years until May 26th 2020 to meet the requirements of the MDR. For certain devices this transition period can be extended until 26 May 2024. However, special requirements must be met to be grant the extension.

The changes

The MDR differs in several important ways from the EU’s current directives for medical devices and active implantable medical devices. Changes in the regulation include expansion of the scope of products covered, more rigorous requirements for clinical evaluation including changes to clinical investigations, mandatory unique device identification (UDI) mechanisms, and increased post-market oversight by EU Notified Bodies.

Specific changes include:

Product scope expansion – the definition of medical devices and active implantable medical devices covered under the MDR is expected to be significantly expanded to include devices that may not have a medical intended purpose, such as coloured contact lenses and cosmetic implant devices and materials. Also for inclusion within the scope of the regulation are devices designed for the purpose of “prediction” of a disease or other health condition.

Reclassification of devices according to risk, contact duration and invasiveness – the MDR will require device manufacturers to review the updated classification rules and update their technical documentation accordingly by considering the fact that class III and implantable devices will have higher clinical requirements and a regular scrutiny process.

It is expected that device manufacturers will also be required to collect and retain post-market clinical data as part of the ongoing assessment of potential safety risks. These changes will result in a dramatic increase in the time and resources needed by manufacturers to conduct the required studies and to maintain post-market documentation.

More rigorous clinical evidence for class III and implantable medical devices - manufacturers will need to conduct clinical investigations in case they do not have sufficient clinical evidence to support the claims done on both safety and performance of a dedicated device.

Systematic clinical evaluation of Class IIa and Class IIb medical devices – manufacturers will need to re-prepare their clinical evaluations by considering the new wording of the regulation on equivalence approach and under which circumstances it is possible to justify not conducting a clinical investigation.

Identification of “qualified person” – device manufacturers will be required to identify at least one person within their organisation who is ultimately responsible for all aspects of compliance with the requirements of the new MDR. The organisation must document the specific qualifications of this individual relative to the required tasks. Further, qualifications of responsible persons will be subject to review by Notified Bodies to ensure requisite knowledge and skill.

Implementation of unique device identification – the MDR mandates the use of unique device identification (UDI) mechanisms. This requirement is expected to increase the ability of manufacturers and authorities to trace specific devices through the supply chain, and to facilitate the prompt and efficient recall of medical devices that have been found to present a safety risk.

To support this effort, the European Databank on Medical Devices (Eudamed) is expected to be expanded to provide more efficient access to information on approved medical devices.

Rigorous post-market oversight – the MDR will grant Notified Bodies increased post-market surveillance authority. Unannounced audits, along with product sample checks and product testing will strengthen the EU’s enforcement regime and help to reduce risks from unsafe devices. Annual safety and performance reporting by device manufacturers will also be required in many cases.

“Manufacturers of medical devices will soon face major changes in the EU’s decades-old regulatory framework” - Richard Poate

Specifications – the MDR will give the EU Commission or expert panels the authority to publish Common Specifications. These Common Specifications would exist in parallel to the Harmonised Standards and will be seen as State of the Art, and would be considered as part of the evaluation process by Notified Bodies.

No “grandfathering” provisions – under the MDR, all currently approved devices must be recertified in accordance with the new requirements. Manufacturers with currently approved devices will have three years to demonstrate compliance with the MDR’s new requirements. Exemptions are under negotiation right now.

About TÜV SÜD Product Service

TÜV SÜD Product Service is one of the world’s leading experts in product testing and certification, with 150,000 product certificates in circulation globally. TÜV SÜD Product Service analyses over 20,000 products each year in Europe, Asia-Pacific and the Americas, ensuring that products are safe, reliable and compliant and minimising liability risks for manufacturers, importers and retailers.

TÜV SÜD Product Service’s Machinery Safety Division is the UK market leader in machinery safety, providing a range of services on a world-wide basis. It is also the official partner of the Process and Packaging Machinery Association on regulatory affairs.

TÜV SÜD Product Service’s sister company, TÜV SÜD BABT, is the world’s leading radio and telecommunications certification body, and is a Notified Body under the European Union’s Marine Equipment, Radio Equipment and Machinery Directives.

How you can prepare?

It is important to note that, as an EU regulation, the MDR will have the force of law throughout the EU after the date of application. This approach will eliminate country- by-country interpretations of the requirements permitted under current directives and is also likely to speed up the actual effective date of the MDR’s requirements across the EU.

The complex development process for medical devices, combined with the changes, are likely to make the transition period a complicated and time-consuming process for most device manufacturers.

Because of these complexities, medical device manufacturers are well-advised to stay current on the progress of the MDR through the regulatory approval process, as well as additional changes that may impact them.

In addition, since a large number of medical devices are expected to require Notified Body review and approval, delays in the review and approval process by Notified Body should be expected. Manufacturers of currently approved devices are therefore advised to evaluate potential compliance issues and to develop a plan to address them promptly, if they want their products to remain on the EU market. Advanced preparation and early action will be key to ensuring a smooth transition to the new requirements.

Author details:

Richard Poate is Senior Manager at TÜV SÜD Product Service, a global product testing and certification organisation, and at its sister company, TÜV SÜD BABT, the world’s leading radio and telecommunications certification body

Richard Poate

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