After a one-year delay and a lot of industry efforts, the European Union’s new medical device regulation will come into force on Wednesday. Device makers have addressed some of the short-term pressures, but still face a series of uncertainties and potential issues looming on the horizon. Here are five key questions as the regulations come into force.
Are there enough certified notified bodies?
The European Commission’s Nando database currently lists 20 notified bodies designated under the MDR. Fifty notified bodies are designated under the outgoing Medical Devices Directive. Taking into account the four IVDR notified bodies brings the total number of organizations approved under the incoming regulations to 24.
Many MDR notified bodies have only obtained their designation within the last 18 months. Having aimed to have 20 notified bodies in place at the end of 2019, the Commission finished the year with nine for MDR and three for IVDR. The current impact of the notified bodies designated as the MDR approaches will be limited, taking into account the conformity assessments take months complete.
Yet there is evidence that the industry has avoided a crisis in the short term. In the last three months of 2020, manufacturers took the opportunity to recertify their medical devices under outgoing guidelines, delaying the need for MDR certification until 2024. Investigations of notified bodies by the Team-NB trade group, the number of private label certificates that expire in 2024 increased from 7,272 in September to 9,953 in December.
The wave of private label recertifications has saved the industry time but, as Team-NB has warned, there is a risk that the flood of certificate expirations in 2024 will overwhelm Notified Bodies’ ability to process MDR applications and lead to product shortages. The number of expirations in 2024 has increased by 37% since Team-NB issued the warning.
Another question from the Team-NB survey illustrates the amount of work notified bodies need to do by 2024. Notified bodies have declared 17,383 MDD certificates, compared to just 181 MDR certificates. The trade group said the results show that only 1% of MDR certificates were issued. Another 10% are at the application stage, mainly in the certification process. the inability to get along on a harmonized European approach to remote MDR audits is currently hampering efforts to process requests.
What’s the latest with IVDR?
The challenge of transitioning from MDD to MDR by 2024 is compounded by the overlap with IVDR. While the EU has pushed the MDR application date back by one year in response to COVID-19, it has left the 2024 expiration date for MDD certificates and deadlines for IVDR unchanged. The approach avoided a crisis in May 2020 but, in the sight of MedTech Europe, “amplifies the already existing bottleneck in resources”.
Additional MDR and IVDR capacities are to come. The Commission had 32 outstanding MDR requests and 10 pending IVDR requests to March 4. One of the outstanding MDR applications has since been completed and the Notified Body has been added to Nando.
However, many applications are still at the beginning of the process. Excluding the notified bodies currently in Nando, the Commission had completed the joint on-site assessments of 20 MDR notified bodies and 3 IVDR notified bodies by 4 March at the latest. None of the IVDR notified bodies had completed the review of their corrective and preventive actions (CAPA) by the joint assessment team. Eight of the MDR notified bodies had reached this stage.
The progression between stages can take months. The number of bodies notified to reach the CAPA examination phase was in fact between December 2020 and March 2021 due to the withdrawal of UK organizations and lack of progress elsewhere.
Are there any issues with Brexit?
The Brexit-imposed removal of UK notified bodies from the European pool was one of the many ways voting to leave the EU complicates the MDR. According to the MDR’s original timeline, the regulations would have taken effect before the UK completed its separation from the EU at the end of 2020. As such, the MDR would have automatically applied to the UK.
The postponement of the MDR application date until 2021 brought the regulation outside the scope of the EU Withdrawal Agreement law. MDR therefore goes not to be implemented in England, Scotland and Wales, collectively known as Great Britain.
However, the terms of the Brexit deal leave Northern Ireland, the UK’s fourth jurisdiction, subject to EU law. The result is that the MDR and IVDR will apply in Northern Ireland and will have to coexist with the regulatory environment of the UK government. creates through the Medicines and Medical Devices Bill.
The Medicines and Health Products Regulatory Agency has shared details the effects of diverging UK regulatory requirements on device manufacturers. However, the real impact will only become clear over time.
Switzerland is also ready to become a third country of the EU in the context of medical devices in the middle of permanent incapacity politicians to reach an agreement. In this scenario, Swiss companies will need a representative in a Member State to enter the EU.
What is the status of the Eudamed modules?
The Eudamed database was initially supposed to be ready when the MDR goes live in 2020, but the Commission delayed its introduction within two years in 2019. Even after the MDR delay, the regulation still comes into force before the availability of database modules essential to manage many of the requirements it imposes.
Eudamed modules are uploaded as soon as they are ready. The module on stakeholder registration went to live in December and two modules on UDI / Device Registration and Certificates and Notified Bodies should be ready by September. The Commission has not yet communicated details of when the other three modules, which cover clinical investigations and performance studies, vigilance and post-market surveillance, and market surveillance, will be ready.
What remains to be resolved?
MDR is ongoing, but the Eudamed Mods are far from the only pieces of the puzzle that will arrive after the application date. the rolling implementation plan, which was last updated in April, shows that harmonized standards for devices and common specifications for non-medical products have yet to be established. Both sets of materials are due in the third quarter.