A new tool is available through which you can get an overview of data relevant to the uptake of the EU Regulations.
The 36-month-long study which started in December 2022 was commissioned by the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) – through the European Health and Digital Executive Agency (HaDEA). Its purpose is to examine the implementation of the Regulations and identify potential challenges to the industry.
At several stages, the study team will be collecting information from industry stakeholders including Notified Bodies, Manufacturers, Authorised Representatives, health service providers, patient representatives, and Competent Authorities.
The dashboards provide information such as:
- Total number of Notified Bodies designated.
- Number of applications received.
- Number of agreements signed.
- QMS and product certificates issued.
- Refused applications.
The above data is also broken down into the different Annexes against which applications are received and certificates are awarded. Whilst this information is not going to be particularly useful to manufacturers, it may help policymakers in the future make better-informed decisions.
Currently, it seems like there have been a total of 12,000 MDR assessment applications received in total, with only 7,900 of these resulting in a signed agreement. The more sobering statistic is that, to date, there have only been around 3,000 certificates issued in total.
You can take a look at the dashboard at this link.