We have seen the EU medical device reforms in the shape of the Medical Device Regulation 2017/745 (MDR) and In Vitro Diagnostic Regulation 2017/746 (IVDR) coming into effect in stages over recent years. Three of the six modules of the EUDAMED database are now available for voluntary use.
The process and timing
Meanwhile, in the UK a consultation has been under way to reboot and update the existing older law, based on earlier EU legislation (more on that process here). Current political pressure to simplify EU-based legislation may see further changes. However, we expect the bulk of the planned reforms to be carried through, with new laws being introduced in the coming months and to be in place in time for the end of the current transition period in June 2023.
Many in the industry have expressed concerns around the ability of both Conformity Assessment bodies and producers to adapt to a new system in this timeframe. These concerns have been addressed with extended transition arrangements. These would allow products that are CE marked under the MDR or IVDR to be placed on the Great Britain market for five years, or until expiry of their certification if sooner. Products that are CE marked under the old EU legislation before the date of the UK reforms will benefit from a transitional period of three years (five years for IVDs) or expiry of their certification if sooner. There are some exceptions to these arrangements, but they will provide welcome flexibility for producers.
The consultation and Government response can be seen here. The whole range of device regulation from product definition to post-marketing surveillance is covered. Different organisations will find areas of particular relevance for them across the proposed reforms. We highlight a selection of the planned changes below.
Which products are in scope?
Current definitions exclude devices without a medical purpose. The proposals would extend beyond the current classes of products to bring in certain non-medical products but having a similar risk profile. These might include categories of cosmetic products such as dermal fillers, or those with an aesthetic purpose like coloured contact lenses, and certain diagnostic tests for health and wellbeing purposes like genome testing to optimise nutrition.
Unique device identification
The EU introduced Unique Device Identification (UDI) with its recent reform package. The UK also plans to bring in UDI, although it plans to follow the Global Medical Devices Nomenclature rather than the EU’s EMDN system as it has wider international coverage. UDI will be required for devices being placed on the Great Britain market, alongside more extensive collection and storage of data about devices to improve follow-up and enhance patient safety.
The dramatic growth in recent years of Software as a Medical Device (SaMD) has exposed serious regulatory shortcomings for this group of products. The proposed changes are substantial and will see the introduction of a definition of software (“A set of instructions that processes input data and creates output data”) with consideration of further definitions and guidance to clarify related terms.
Risk classification for SaMD will become more closely aligned to international norms through inclusion of the IMDRF classification rule. (IVDs will not follow this route as this would introduce significant divergence from the EU IVD systems.)
An “airlock classification rule” offering a conditional authorisation where the risk profile for SaMD is not well understood remains on the table, but is earmarked for further analysis and development.
Statutory changes relating to AI medical devices are not currently proposed, although detailed guidance can be expected.
Alternative routes to market
The MHRA intends to proceed with its proposals to introduce new routes to market utilising (a) the Medical Device Single Audit Program and (b) a Domestic Assurance route for devices that have been approved in other countries. An innovative MedTech route in collaboration with the National Institute for Health and care Excellence (NICE) is also planned. While the details and scope of these routes are not fleshed out, the promise welcome additions for international producers and those developing innovative products.
The consultation and response documents are extensive and we have touched on only a few of the planned changes. We are yet to see the legislative proposals. However it is clear that device producers will face a substantial task in understanding them and achieving compliance. The acceptance that several years will be required for full compliance to be reached is welcome.