The day is finally here! Four years after it entered into force, the Medical Devices Regulation (MDR) is applicable today, the 26 May 2021. We have discussed the aspirations and implications of the MDR, we have commented on the slow rate of implementation, and we have heard, and share, some of the frustration expressed by companies as they have prepared for today. From today, industry, regulatory bodies, external advisors and customers will be able to experience the consequences of the radical reform of the medical devices regulatory framework that has been introduced by the MDR.
We have published several blog posts on the key changes and progress of the implementation of the MDR. In this post, now the MDR is officially applicable, we briefly cover where we stand in relation to some of the issues and concerns for the industry. The European Commission recently said that “the 26th of May is not an end date” and we couldn’t agree more. While the MDR was focused on increasing patient safety and the oversight of devices, there is still a lot of work to be done, and there remains a number of outstanding questions. We believe there will need to be a great deal of flexibility by all parties over the coming months in other to avoid disruption for patients.
While the MDR is now applicable, some medical devices can remain on the market under the transitional provisions under Article 120. However, even if the device is to stay on the market under the current Medical Devices Directives (MDD), and there are no significant changes made to the device, certain parts of the manufacturers Quality Management System must comply with the MDR. There are also questions about how many of the other provisions in the MDR apply to these legacy products, and how these provisions should be evidenced by companies, or will be monitored or enforced by the relevant authorities.
In addition, there is the added complication of the position in Switzerland. Despite years of negotiation, Switzerland and the EU have not signed a new Mutual Recognition Agreement that would extend the current provisions whereby conformity assessments are recognised between the EU and Switzerland. Therefore, Switzerland, like the UK, is now a third country for the purposes of the MDR. There have been discussions about a limited modification being agree whereby certificates already issued in Switzerland would be granted the same transitional provisions as apply under the EU MDR. However, this has yet been agreed, and in practice, due to the late timing, many companies have already changed their supply chains to address “Swixit”.
Remember also that while the UK is now a freestanding regulatory regime outside of the EU, the MDR will apply in Northern Ireland. It will not, however, apply in Great Britain, although the UK government will be consulting on updates to the UK regulations in due course. The UK will continue to accept EU CE marked devices on the Great Britain market, including under the MDR, until 30 June 2023. In the meantime, this separation of regulatory regimes within the UK is providing a great deal of complexity for manufacturers.
One of the most important open issues creating concern for industry is notified body availability. The MDR has significantly strengthened the requirements and revised the procedures under which notified bodies can be designated. The assessment of applications for designation started a long time ago, but to date, the number of notified bodies that can provide conformity assessment services under the MDR remains limited: there are currently 20 MDR designated notified bodies, less than half of the notified bodies designated under the MDD. While many medical devices companies will continue to place their devices on the market under the MDD as a result of the transitional provisions, the longer we have limited availability of MDR designated notified bodies, the greater the risk of disruption or delay to the supply of medical devices.
The industry has only very recently received harmonised standards that are needed to help manufacturers ensure product safety and quality, and to demonstrate compliance with the relevant legislation. Under the MDR, the existing standards harmonised under the previous regulatory framework had to be revised and new standards developed. For this purpose, the Commission had to submit a request to the two relevant European standardisation organisations, CEN and Cenelec. Despite the importance of these standards for manufacturers, an updated request was only made in March in a Commission Implementing Decision and accepted earlier this month, and MDCG guidance 2021-5 on standardisation for medical devices was published in April.
Additionally, important guidance documents relevant to key requirements under the MDR are still outstanding, including on the use of Eudamed during the transitional period, the classification of medical devices, clinical evaluation and post-market surveillance and vigilance requirements. Eudamed is also not yet fully operational and the European Commission is making available modules on a gradual basis as they are functional. Needless to say, this is far from ideal.
Industry continues to struggle with the new rules governing economic operators and their roles and responsibilities within the supply chain. Despite the fact that the provisions in the MDR are primarily based on the existing guidance under the MDD, there are many questions and differences of opinion around the practical issues arising as companies seek to update their systems and contractual relationships. Several guidance documents on market surveillance are due to be published this year by the MDCG, including guidance on authorised representatives, re-labelling and repackaging, and Q&As on importers and distributors. In the meantime, companies have to make decisions on how they will operate under the MDR, and the updates necessary to their systems and relationships, based on first principles and a pragmatic interpretation of the MDR. This is far from satisfactory, and the industry awaits further certainty on how these provisions will be interpreted.
The focus has been on the date of application of the MDR, as this was first in line. However, we should not forget that the In vitro Diagnostic Regulation is applicable in May 2022, and urgent progress needs to be made regarding its implementation. This is particularly so because the transitional provisions under the IVDR will apply to far fewer IVDs that are currently on the market, and vastly more products will need to be certified by a notified body under the new procedures if they are to stay on the market after May 2022. To date, there are only 4 notified bodies designated under the IVDR. We anticipate increasing difficulties in this area over the next year, and that the calls for a delay in the date of application of the IVDR will increase in volume accordingly.