The Medical Device Coordination Group (MDCG) approved the guideline on significant changes required by article 120 of the MDR concerning the Period of Grace MDD or AIMDD certificates.
The article 120, paragraphs 2 and 3, of the MDR (EU) 2017/745 states that the devices with a valid certificate, released by a Notified Body according to MDD or AIMDD, can be placed into the market or put into service after the MDR application date under certain conditions and not later than May 26, 2024.
One of these conditions is that no significant change in the product occur and it is therefore fundamental for the Manufacturers and Notified Bodies to understand what “significant change” means.
In fact, no emission of new MDD/AIMDD certificates, including those modified or integrated, are allowed pursuant to article 120, paragraph 3. In particular, if the Manufacturer wishes to apply a “significant change in the design and intended purpose”, the implementation of such change is verified by the Notified Body and the evaluation determines if a certificate, in compliance with the MDD/AIMDD, keeps its validity pursuant to article 120 of the MDR.
The guideline includes flow charts, a main chart and five sub-charts, to support Manufacturer and Notified Bodies to assess if a change must be considered significant or not according to article 120, paragraph 3, of the MDR.
MDCG recently published other guidelines:
- MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
- MDCG 2020-2 Class I Transitional provisions under Article 120 (3 and 4) – (MDR)
- MDCG 2018-1 v3 Guidance on BASIC UDI-DI and changes to UDI-DI