(Source: European Commission)
“Check against delivery”
It has been three weeks since the entry into application of the In Vitro Diagnostic Medical Devices Regulation and one year since the entry into application of and the Medical Devices Regulation.
Taking stock of where we are, we should first acknowledge the progress made over the last year.
First, we have now 30 conformity assessment bodies for Medical Devices and 7 for In vitro diagnostics.
Second, the development of the European database on medical devices has advanced, with three out of six technical modules available for voluntary use.
Third, the expert panels established last year have already provided 18 scientific opinions for the certification of certain high-risk devices and the transfer to the European Medicines Agency in March has been smoothly achieved.
However, despite this progress, significant challenges remain.
While around 1,000 certificates have already been issued under the Medical devices regulation, more than 24,000 previously issued certificates will expire by May 2024.
These are very concerning figures which require strong and immediate actions from all of us.
We cannot risk facing shortages and it is therefore extremely important that manufacturers get ready for the new requirements before the transition period ends.
At the same time, we must do our part and ensure that there is sufficient notified body capacity in the Member States to ensure timely certification.
This is why we have initiated work in the Medical Device Coordination Group to agree on a list of actions to enhance notified body capacities and preparedness of economic operators to ensure the availability of safe medical devices.
Avoiding shortages of essential medical devices is our highest priority.
We are exploring all options available within the existing legal framework and have already identified some possible solution- oriented actions.
These could include a range of measures to alleviate the burden of notified bodies to allow them to fully focus on certifications under the new Regulations.
They would also increase preparedness of manufacturers and facilitate the transition to the new Regulations.
These could range from coordinated market surveillance measures, changing the frequency of reassessment of notified bodies and facilitating the use of hybrid audits.
Certification of certain devices such as orphan devices and some legacy devices could become subject to certain targeted conditions to alleviate the strain on the market.
We should avoid at this point in time a further delay of the Regulations as a simple extension of the transitional period would not solve the problem, it would simply postpone it.
This is a joint endeavour and it is essential that we all actively engage in this process, and commit the necessary resources and we engage with industry and notified bodies.
Together, we have the responsibility to ensure an adequate implementation of these two Regulations.
Let us not forget that the prime objective of these two Regulations is to improve the safety and performance of devices for the benefit of patients and of public health.
While we must of course avoid shortages of critical devices, the safety of our citizens must be remain the main objective.
As ever the Commission will continue to closely monitor this situation and continue to take stock of progress made.
I am open to taking stock of the situation again with you in December.