New medical device regulation causing widespread industry confusion
03 December 2018
The European Commission has instigated a major restructure to the EU’s medical device regulatory framework, and medical device designers and manufacturers now face significant changes.
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), as well as the 98/79/EC.
The MDR introduces a completely new compliance landscape. Regulations, like the MDR, have binding legal force throughout every Member State, and they also enter into force on a set date across all the Member States. Whereas directives, like the old MDD, 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 therefore much more than a simple update to existing legislation. Instead, it represents a major upgrade of all conformity assessment procedures to reflect the state of the art. This upgrade requires that every applicable device undergoes a new conformity assessment. This means that there is no legacy caveat i.e. products that have been on the market for a long time must undergo the same compliance process as new products, in order to comply with the MDR. It therefore represents a level playing field for both existing design and newly developed products.
Specific changes introduced by the MDR include, but are not limited to:
• Expansion of the types of products which must comply with the new MDR resp. IVDR.
• Reclassification of devices according to risk, contact duration and invasiveness.
• More rigorous clinical evidence for class III and implantable medical devices.
• Systematic clinical evaluation of Class I, class IIa and Class IIb medical devices.
• Identification of at least one “person responsible for regulatory compliance” with the requirements of the new MDR.
• Implementation of unique device identification mechanisms.
• Notified bodies granted rigorous post-market oversight, such as unannounced audits, product sample checks and testing.
• No “grandfathering” provisions, so that all currently approved devices must be certified in accordance with the new requirements of the MDR.
• Introducing expert panels and reference laboratories.
Market delays expected
The implementation period of three years, with an additional four years transition period, represents a lot of time, resource and money for medical device manufacturers, which will be turning to expert test houses and notified bodies for support.
This new MDR regulation also expands significantly the requirements for notified bodies. Taking all the changes into account, it does not appear feasible that all manufacturers and all their products can be transferred to the new regulation before May 2020 (for the MDR) or May 2022 (for the IVDR). The additional transition period until May 2024 will therefore be needed to allow all manufacturers to move on to the new legislation.
With the new classification rules, the number of products falling under the control of notified bodies increases significantly. However, notified bodies also find themselves operating in an increasingly challenging environment. Many Notified Bodies may be unable to provide all the support in the time frame that device manufacturers hoped for.
All of this major change means that it is vital that notified bodies are (re-)designated as early as possible, in order to have sufficient numbers available to assess products before manufacturers can place them on the market. However, findings from a recent survey (by Team-NB) of notified bodies in Europe suggests that the audits required for notified body compliance with the new medical device regulation (MDR) will not be completed before May 2020. Out of a total of 58 relevant notified bodies, 35 responded to the survey. Only seven of the 35 notified body respondents had an assessment (as of July 2018), and not a single notified body may be designated this year.
These assessments must be done by the European Commission, the supervising Competent Authority of the Member State (where the notified body to be (re)-notified has its headquarters) and at least two further supervising Competent Authorities of other Member States. This joint assessment process is likely to allow approximately 15 notified body (re-) designation processes per annum. With currently over 50 notified bodies in Europe, this therefore creates a huge gap in support for the medical device market. It also makes it highly unlikely that all medical device firms will have a notified body audit on time for the new regulation.
Under the new IVDR, the number of IVD products alone that will now fall under notified body control has at least quintupled. As there are stricter requirements for the control of manufacturers by notified bodies, this has increased the assessment workload for both the IVD and MD sector – meaning that notified body inspections and their assessment workloads are at least doubled per product, the quantity of which has been quintuplicated. It will therefore be extremely difficult for manufacturers, which have so far not been subject to control by a notified body, to find one to support them within the timescale.
The complex development process for medical devices, combined with the MDR changes, are likely to make the transition period a complicated, time consuming and stressful process for most device manufacturers. On top of this, the delays in the notified body (re)-notification process means that national and European legislators must quickly agree a procedure.
Due to these delays, the harsh reality is that those firms that have not yet finalised a comprehensive strategy to ensure compliance after the shift to MDR/IVDR will experience delays to new products being placed on the market. As there is an additional transition period until May 2024 for devices that are certified under MDR, this additional time is not foreseen for class I devices. Well established class I devices will need to be transferred to the MDR at the latest in May 2020 - otherwise they cannot be placed on the market and won’t be available for patients.
Since a large number of medical devices are expected to require notified body review and approval, manufacturers of currently approved devices and quality management systems are therefore advised to evaluate potential compliance issues and to develop a plan to address them promptly. This should also include conducting an impact analysis so that decisions can be made about which devices remain within a product portfolio.
Contact Details and Archive...