Medical Electronics


Coping with a major restructure of the medical device regulatory framework


The Medical Device Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR) entered into force on 25 May 2017, replacing the Medical Device Directive (93/42/EEC) and the Active Implantable Medical Devices Directive (90/385/EEC). Richard Poate, 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, tells us how to cope with the major restructure of medical regulations


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. Device manufacturers will also be


Richard Poate T


his new legislation expands significantly the requirements for both medical device manufacturers and Notified Bodies, as the MDR is much more than an upgrade to existing legislation. Instead, it represents a completely new approach to ensuring medical device compliance, requiring that every applicable device is recertified. This means that most manufacturers of


currently approved medical devices will have a transition time of just over 1.5 years until May 26th 2020 to meet the requirements of the MDR. Specific changes include: Product scope expansion – the definition of medical devices and active implantable medical devices covered under the MDR is


22 October 2018


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” – Components in Electronics


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.


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.


Testing times ahead The MDR introduces a completely new compliance landscape. Regulations (the MDR) have binding legal force throughout every Member State and enter into force on a set date across all the Member States. Directives (the old Medical Device Directive) lay down certain results that must be achieved, but each Member State is free to decide how to transpose directives into national laws. The MDR is a regulation, it will have the


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.


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


force of law throughout the EU after May 26th 2020, and the transition period is likely to be a complicated and time consuming process for most device manufacturers. 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 should be anticipated. If you want your products to remain on the EU market, advanced preparation and early action will be key to ensuring a smooth transition to the new requirements.


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