BSI announced in June 2021 updates concerning certificates issued for medical devices covered by Article 120 of the Medical Devices Regulation (MDR) 2017/745 (legacy devices). The updates concern two topics:
1. Changes reported by manufacturers to the Notified Body
According to MDR Article 120 (3), medical devices covered by a valid CE Certificate under AIMDD/MDD are favored by the transitioning periods of MDR Article 120, i.e., may continue to be placed on the EU market until their CE Certificate is valid or, at the latest, until May 26, 2024, if there are no significant changes in their design or intended purpose.
If the changes are allowed by MDR Article 120 (3) and MDCG 2020-3, then manufacturers need to submit the change to the Notified Body, according to the applicable conformity assessment Annex of the MDD or AIMDD. On the contrary, if changes are not allowed under MDR Article 120 (3), manufacturers should apply for a Certificate, according to the MDR framework.
2. Changes included by the Notified Body to issued Certificates.
The guidance on significant changes in the design or intended purpose – stresses in Part 3 that from May 26, 2021 Notified Bodies are not allowed to issue new certificates, even in the case of “modified, amended and supplemented certificates” (MDCG, 2020) under the MDD/AIMDD. Part 4 states that Notified Bodies should proceed with written confirmation of the changes that do not constitute a significant change in the design and intended purpose under MDR Article 120 (3). Following the MDCG guidance, BSI decided that from May 26, 2021 they will not perform changes to significant pages of certificates under MDD/AIMDD and approved changes will follow two distinct processes according to the type of certificate.
- Certificates based on quality system annexes: BSI will not perform changes on the main certificate. Nevertheless, it can proceed with updates to supplementary pages that do not constitute part of the main certificate. In case of allowed changes, they will issue a letter after the completion of the process, including the recent changes approved by the Notified Body as part of the process;
- Certificates based on product annexes: although BSI will not allow changes on the main certificate, they can issue a supplementary page including the change history. Here, again, when the process is completed, a letter will be provided with all recent changes approved by the Notified Body as part of the process.
Legacy Devices and the Medical Devices Regulation 2017/745
MDR Article 120 (3) grants legacy devices that comply with the requirements of MDD and applicable MDR provisions additional time for placing on the market after the MDR date of application. Additionally, Article 120(4) allows legacy devices to be made available on the market and put into service until 27 May 2025. [AMORD1] . Therefore, manufacturers need to ensure that, by May 2024,their medical devices comply with the MDR requirements – including obtaining a CE Certificate issued by a Notified Body – to continue placing their devices on the EU market.
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· European Parliament and Council. (2017). REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Retrieved on 24.09.2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745
· MDCG. (2020). MDCG 2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD. Retrieved on 24.09.2021 from https://ec.europa.eu/health/md_sector/new_regulations/guidance_en
· BSI. (2021). Devices covered by AIMDD/MDD certificates from 26 May 2021. Retrieved on 24.09.2021 from https://www.bsigroup.com/en-GB/medical-devices/news-centre/enews/2021-news/devices-covered-by-aimddmdd-certificates-from-26-may-2021/