On June 6th, 2019 the European Union released a document, with a note from the Irish and German Delegations on the implementation of Regulation (EU) 2017/745 on medical devices. The document addresses the increased number of discussions regarding the challenges and concerns facing stakeholders (manufacturers, notified bodies, authorized representatives, distributors, competent authorities, European Commission) in the medical device sector to implement the new Regulations in a timely and effective manner.
Much of the concern comes as a result of the availability and capacity of notified bodies for the medical devices under the new Regulation (EU) 2017/745. Although the European Commission and Member States are committed to designating notified bodies by the Regulation implementation date of May 2020, the Irish and German Delegations emphasize there will still be significantly fewer notified bodies than the ones who currently exist. Another concern brought up pertains to, what the impact of a lack of notified bodies could mean for up-classified devices such as surgical instruments which are intended to be reused, that need to be re-certified under MDR by May 2020. According to the document, this could lead to shortages in the market for critical medical devices.
In addition, the Regulation (EU) 2017/746 on in-vitro diagnostic medical devices is also referenced in an attempt to emphasize that 80% of in-vitro diagnostic devices will have to be certified by a notified body by May 2022, whereas prior to the regulation 80% of in- vitro diagnostic medical devices where self-declared by the legal manufacturer without the input or certification from a notified body. Aside, from notified bodies’ capacity, other challenges noted on a national and EU level include system requirements, infrastructure and secondary legislation. Overall, there is a concern for the lack of clarity, and available guidance on numerous requirements of the regulation and what the overall expectations of the regulatory system will be.
In conclusion, the Irish and German Delegations applaud the commitment of Member States and the European Commission on the significant work of implementing these new Regulations. However, they insist, that it is necessary that there are appropriate levels of resources and infrastructure put in place in each Member States and EU level in order to guarantee effective implementation, operation and coordination of the regulatory system. Furthermore, the two delegations suggest 3 steps that need to be undertaken in order to move towards a seamless launch of the new regulatory system. These steps include:
- Member states should revise their state of preparedness for the implementation of the new Regulations, at a national level with the European Commission and at a European level;
- Challenges within the implementation of the new Regulatory framework should be identified, addressed, solved or mitigated against. Solutions should be given for each challenge;
- Extensive discussions on this topic should take place between the European Commission, Member States, and when or if necessary, the European Parliament before the end of 2019;
It is also importatn to note that, during the 3698th Council meeting held in Luxembourg, 13 and 14 June 2019, the discussions confirmed that the concerns raised by both Members’ States as to the readiness to implement the Regulation (EU) 2017/745 on medical devices by May 2020 is shared by other delegations. The Commission interceded, forecasting that 20 Notified Bodies will be designated until the end of 2019 and insisted that the application date of May 2020 was still a reasonable deadline for the implementation of the new European regulation.