To prevent market disruptions and give manufacturers enough time to certify their medical devices under the new Regulations (MDR and IVDR), medical devices certified under the previous Directives can be subject to a grace period. Recent decisions just prolonged this transition under MDR, bringing a longer legacy period and an extended validity of CE certificates.
After the Proposal’s adoption in January 2023 and the European Parliament’s vote in February, the Council of the European Union approved the new transitional period on 7 March 2023. With the publication of the amendment in the Official Journal (OJEU) of the EU on 20 March 2023, the new legacy period is now official. Thus, the new amendments apply from 20 March 2023.
Automatic extension of CE Certificate’s validity
Manufacturers’ options vary based on whether the CE Certificate has expired before or after 20 March 2023. The extension can be automatic if the certificate has expired after the OJEU’s publication date. The automatic extension applies if the manufacturer meets the following requirements:
- No significant changes to the device after the MDR date of application.
- No unacceptable risk to health and safety.
- Legacy requirements followed as set out by MDR.
- MDR complaint QMS by May 2024
- MDR conformity assessment application with a notified body by May 2024 and signed agreement by September 2024.
Expired certificates before 20 March 2023
If a certificate has expired before the publication of the new Regulation, manufacturers have the following options to extend the certificate’s validity:
- The Competent Authority of an EU Member State grants a derogation to place medical devices with an expired CE certificate on the market.
- A signed agreement with a Notified Body before the Certificate has expired. Alternatively, if a non-EU manufacturer already has a CE Certificate issued under MDR, the Authorised Representative will review the documentation and sign the mandate, allowing them to place medical devices on the EU market.
Removal of IVDs sell-off provisions
The latest amendments also address IVD medical devices. Similar to medical devices, from 20 March 2023, there is no sell-off provision for IVDs either. This means that there is no longer an end date from which the devices already on the EU market shall be recalled from the market, a requirement of the initial transitional period.
How to benefit from the extension: Authorised Representative’s role
Obelis assists manufacturers in benefitting from the new extension period in several ways:
- One essential requirement set by the new amendment is compliance with legacy requirements. The EAR ensures that the manufacturer meets the legacy requirements and has an MDR compliant QMS.
- If the manufacturer opts for a derogation, the EAR applies for the derogation under Article 59 of MDR. After that, Competent Authorities can grant a derogation under Article 59 or 97. Typically, a derogation under Article 97 is valid for the whole European Union.
- If there is no signed agreement with a notified body, the manufacturer needs to apply to a notified body for MDR conformity assessment and have a written agreement as soon as possible and within September 2024. Obelis helps manufacturers to find the right notified body and increases their chances of having a signed agreement within the deadlines.
Do you have any questions about the new transitional period? Contact us today.
Simona Varrella
Publications Department
20/03/2023
References:
OJEU. (20 March 2023). Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. Retrieved on 20/03/2023.
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