Brussels, 6.1.2023
COM(2023) 10 final
2023/0005 (COD)
Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
In summary:
1. Remember that at the moment it is only a proposal (but it comes from the EU commission)
For legacy device
2. 31 December 2028, for class IIb devices other than those covered by point (a), for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function.
3. 31 December 2027, for class III devices and for class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors;
4. class III custom-made implantable devices may be placed on the market or put into service until 26 May 2026
5. Removed the sell-off date
Our company offers courses from different content for different sectors.
Please login to the private area to download the pdf file of the regulations.
View all Bio Chem Srl headquarters in Naples, Rome, Milan
Enable the E-Mail in the registration form to receive information on our initiatives.
From the following link will download the business service evaluation questionnaire regulators.
The area dedicated to external links you will find all the links to our partners.