On 3 July 2023, the Medicines and Healthcare products Regulatory Agency (MHRA) published on its official website the EU MDR Article 120 extension confirmation, a template of the letter to be submitted by Manufacturers to align with Article 120 of the MDR Regulation (EU) 2017/745.
This document is not a guideline but a declaration by the manufacturer: the latter must fill in the form indicating under which condition he can benefit from the extension.
The following is a reminder of the conditions that must be fulfilled for the extension of the validity of an EC certificate under Article 120 and which allow the device to be marketed in the UK.
- In the case of certificates that expired before 20/03/2023, the manufacturer has a signed contract with a Notified Body that precedes the original expiry of the certificate;
- In the case of certificates that expired before 20/03/2023 and where no contract has been signed between the manufacturer and the Notified Body, the former may benefit from the extension if:
- receives a derogation from conformity assessment procedures under Article 59 of the MDR, or
- conformity assessment under Article 97 of the MDR is carried out.
>>>If you want to market Medical Devices and IVDs in the UK, Thema can assist you with the Strategic Regulatory Consulting Service, be appointed UK Responsible Person (UKRP) of the organisation and support you in registering products with MHRA.
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