As you will be aware from previous blog posts, the new EU Medical Devices Regulations (the MDR and IVDR) will be applicable in May 2020 (for medical devices) and May 2022 (for in vitro diagnostic medical devices). The European Commission and medical device coordination group (MDCG) are busy preparing the guidance documents and implementing legislation to ensure the Regulations can function. Notified bodies are also going through the designation procedure to ensure they can accept applications under the MDR and that products can be placed on the market under the new Regulations. However, there is still much to do, and progress has been slow. We set out below an update on the current state of play.
Implementing legislation and guidance
As we noted in an earlier blog, the European Commission has updated its website to collate all of its guidance on the new legislation. The number of guidance documents has increased over recent months, with new information on EUDAMED (including which data from the unique device identifier (UDI) needs to be included in the EUDAMED database), UDIs (including how legacy devices can be registered in EUDAMED without an UDI) and notified bodies (more on which below).
Earlier this month, a further Implementing Decision was also published: Commission Implementing Decision (EU) 2019/939 designating issuing entities designated to operate a system for the assignment of UDIs. The designations made under Article 1 of the Decision will remain valid for five years from 27 June 2019. At the end of that period, each of those designations may be renewed for a further period of five years if the issuing entity remains in compliance with the criteria for and terms of designation. However, at present, only 4 entities are listed in the Annex: GS1, the Health Industry Business Communications Council, ICCBBA and the IFA GmbH, and it remains to be seen whether this limited number of entities able to assign UDIs will lead to delays.
At the recent MedTech Summit conference in Brussels, one of the biggest concerns for companies and regulators alike was the state of notified body designations under the MDR and IVDR. It has been estimated by the Commission that up to 20 notified bodies could be designated by the end of the year, but there is some scepticism about whether this is possible, or even if it is, whether this is enough notified bodies to deal with all the devices that need to go through the new process before May 2020. Further, there are reports that most notified bodies are not accepting new applications under the current medical devices Directives (which would enable a longer transitional period under the MDR). Currently, there are only 2 notified bodies designated under the MDR: BSI UK and TÜV SÜD, although these are two of the biggest notified bodies that are responsible for a large proportion of the certificates under the current Directives. Nevertheless, at present, there is a large capacity gap.
This also comes at a time when current notfied bodies are annoucing closures. Most recently, the London-based notified body Lloyd’s Register Quality Assurance (LRQA) announced that it will withdraw from its notified body services under the current medical devices Directives, and will not apply to be a notified body under the new MDR and IVDR. This is likely to cause concerns for IVD manufacturers in particular, as LRQA is one of the notified bodies that processes a large number of the currently CE certified IVDs in the EU.
Is an extension likely?
As we noted in a previous blog, MedTech Europe, the European trade association representing the medical technology industries, published a position paper calling on the European Commission, the European Parliament and the EU Member States to extend the transition period under the MDR and IVDR. MedTech Europe, together with seven other European Trade Associations, raised similar concerns earlier this month, and called on the European Commission and the Member States to accelerate the implementation of the new regulatory system. Similarly, the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) issued new recommendations on the availability and capacity of notified bodies and the sustainability of the grace period under the MDR. COCIR noted that little progress had been made since its initial report in November 2018, and that essential guidance and information is still missing to enable companies to prepare for the MDR. As such, COCIR recommends limiting initial certification under the MDR to a manufacturer’s quality management system and “a sample of one device per device group for class IIa and class IIb devices at initial MDR certification assessment.” COCIR also suggests that certificates issued under the International Medical Device Regulators Forum’s (IMDRF) Medical Device Single Audit Program (MDSAP) could help offset the lack of notified bodies designated under MDR.
However, the Commission’s response has been to state that the current deadline is “realistic and achievable”. The European Commissioner for Health and Food Safety also said that preparation of the EUDAMED database core modules is on track to be functional in line with the deadlines, and that the establishment of the UDI system and work on implementing acts are close to being finalized. As such, while the Commission has also recognised that the new Regulations could have consequences for the availability of medical devices for health institutions, with the potential for some devices to “become temporarily unavailable”, it does not seem to have current plans to delay implementation.