Set your watches: Expected timing of European Medical Device Regulations
Emergo has received questions about precise timelines regarding the introduction of new European Medical Device Regulations. This indicates there is a strong need within the medical device community to get some indications as to the dates by which certain steps will be taken.
Emergo has access on almost all levels of decision making in Brussels and we make good use of those contacts. Predicting is difficult, especially when it involves the future. So we have to make a huge disclaimer about the predictions made in this blog: this is our ‘best guess’, reality may differ.
Sources from within the inner circle of negotiators and the European Commission are now indicating the following timelines:
- On 14 June 2016 the ‘Comité des représentants permanents’, or ‘Committee of Permanent Representatives’- Coreper – will approve the final wording of the proposals.
- The European Parliament needs to provide a pro-forma approval in a plenary meeting
- The Council will endorse it on 17 June 2016.
- The English version of the Draft Regulations will be published on 20 June 2016.
- After that the Regulations will be translated into 23 national languages.
- Formal publication in the Official Journal of the EU is consequently expected in December 2016 of January 2017.
- With a three-year transition period for medical devices and five years for IVDs manufacturers have to comply in December 2019/January 2020 or December 2021/January 2022 respectively.
Although the delegating and implementing acts regarding the role and position of notified bodies require early adoption, it has not been possible to get any indication of those publication dates yet. Further acts and guidance documents are expected to be published over years until December 2019, and possibly even later. We will keep you informed.
You can now set your watches to meet these deadlines. And for those of you who want to get their hands on the draft Regulations on 20 June and are not based in a European time zone: Set your alarm!
Soon to be expected:
- White paper on Medical Devices, the final wording
- White paper on IVDs, the final wording
- The definition of a medical device; verify your product status
- The definition of an IVD; verify your product status
- Classification of Medical Devices
- Classification of IVDs
- Questionnaire: what training would you like to get from Emergo?
Ronald Boumans is Senior Global Regulatory Consultant at Emergo's office in The Netherlands, and a former senior inspector at the Dutch Healthcare Inspectorate.