| Theme | Transitional provisions |
| Target Audience | Manufacturers |
| Products Concerned | Class I MD (excluding Im, Is) in accordance with the Directive 93/42/CEE that change class in accordance with the Regulation |
| Regulatory reference | MDR (EU) 2017/745
Article 120(3) et 120(4) |
| Documents mentioned | “The ‘Blue Guide’ on the implementation of EU products rules 2016 (2016/C272/01)”
EN ISO/IEC 17050-1 Decision No 768/2008/EC
|
EN – This guide specifies the information to be provided in the declaration of conformity by manufacturers of Class I MD (excluding Class Is and Im) in accordance with the Directive which will change class in accordance with MD Regulation. Indeed, the grace period has been extended to these devices by the corrigendum to the Regulation published in the Official Journal of the European Union in December 2019, provided that a declaration of conformity has been drawn up before 26 May 2021. They may thus continue to be placed on the market until 26 May 2024within the validity of their certificate.
To benefit from this provision, no significant changes in the design and intended purpose of the MD shall be made after 26 May 2021 and the declaration of conformity shall comply with the requirements of Annex VII of the MD Directive, the Blue Guide and EN ISO/IEC 17050-1: Conformity assessment – Supplier’s declaration of conformity – Part 1: General requirements.
The MDCG 2020-3 guide clarifies what must be considered a significant change within the meaning of Article 120 of the MD Regulation
The regulatory requirements for post-market surveillance, registration of economic operators and devices, and vigilance shall still apply under the MD Regulation as of 26 May 2021.