Of the many changes introduced by the EU Medical Device Regulations (EU MDR), one of the most significant is the establishment of the European Database on Medical Devices (EUDAMED). EUDAMED is intended to be a collection of databases containing information on all medical devices marketed in the EU. The EUDAMED provisions of the EU MDR impose obligations on all economic operators – manufacturers, authorised representatives, importers and distributors, to register and submit data on the devices for which they are responsible. Amongst other things, EUDAMED will record post-market surveillance data, allowing users to easily access updated safety information.
It was intended that EUDAMED would apply from 26 May 2020. However, in late October 2019, the European Commission announced a two-year delay, with EUDAMED’s launch being pushed back to 2022.
The announcement of the delay is hardly unexpected. Even in light of the Commission’s reassurances that EUDAMED would launch on time, there had been growing scepticism that this could be achieved. Far from being bad news, however, the delay will undoubtedly be welcomed by economic operators, who (as set out extensively in our earlier articles on the topic), face an uphill battle to be ready for the EU MDR. Representatives from the medical devices industry stated earlier this year that companies would need 18 months from the publication of the EUDAMED functional specifications to prepare their electronic systems. Now, key requirements in the EU MDR referencing EUDAMED (there are nearly 50 such Articles!) will be delayed in coming into full force.
With a new window of opportunity available, economic operators who are not yet ready for EUDAMED are strongly encouraged to take full advantage of the extra time!
As in the case of EUDAMED, the Commission has frequently expressed the view that the EU MDR will come into full effect within the initially indicated timetable. Further, the Commission appears confident that the infrastructure required to support the EU MDR (including notified bodies being designated and industry being prepared) will be in place in time.
Market Surveillance Incoming
The extra EUDAMED time is not necessarily all good news for economic operators. In particular, economic operators will need to pay extra attention to Regulation (EU) 2019/1020 of 20 June 2019 on Market Surveillance and Compliance of Products (MSR). As background, the MSR applies in full from 16 July 2021 and sets a number of post-market surveillance obligations for economic operators. The MSR only applies insofar as there are no specific provisions with the same objective, nature or effect in other EU legislation, and clearly there are surveillance requirements for which the EU MDR takes precedence over the MSR. However, the delay to EUDAMED raises the question of whether substantive provisions of the MSR, which will come into force before EUDAMED is in place, will apply in its absence.
As a result, economic operators may need to understand and prepare to comply with a plethora of simultaneous market surveillance requirements. This will start with the EU MDR in May 2020, followed by the MSR in July 2021 and finally EUDAMED in May 2022. As such, while the delay to EUDAMED does provide more time to economic operators, it potentially further complicates an already convoluted market surveillance framework for medical devices.
Notified Body Update
In addition to the above, since our last update in September, the number of Notified Bodies certified under the EU MDR has increased from four to seven:
- BSI Group the Netherlands B.V.
- TÜV Rheinland LGA Products GmbH
- Dare!! Services B.V.
Furthermore, there are now two notified bodies under the In Vitro Diagnostic Medical Device Regulation. Both BSI Assurance UK Ltd and DEKRA Certification GmbH have received accreditation. These approvals are very good news for an industry which is highly concerned about an increase in regulatory requirements coupled with an absence of approval bodies.
Despite these positive moves, more needs to be done. In particular, it needs to be noted that there were 58 Notified Bodies certified under the Medical Devices Directive and 21 certified under the In Vitro Diagnostic Devices Directive. The relative dearth of Notified Bodies for the new Regulations, combined with the lack of grandfathering under either Regulation and up-classification of a number of devices, still poses a serious risk of an approval bottleneck.