New MHRA Guidance: Marketing IVDs in Great Britain
17 July 2023
EU Commission Updated Survey: MDR/IVDR Certificates & Applications
25 July 2023Today the EU Commission updated the MDR Transition Extension Q&A. The updated version is available: HERE
Background
The Q&A provides practical guidance on how to apply the MDR extension under EU Regulation 2023/607. For example:
- How does a manufacturer show proof that they have met the requirement to implement an MDR-compliant QMS by 26 May 2024?
- Which classification determines the transition period deadline – the current MDD/AIMDD classification or the new MDR classification?
The Updates
New Template – Transition Extension “Self-Declaration” Letter
A template jointly developed by industry associations (AESGP, COCIR, EuromContact, EUROM VI, and MedTech Europe) for manufacturers is now available. The purpose is to self-assert compliance with the MDR transition extension period. It consists of two parts:
- a text part with selectable portions of the text as they apply, and
- a schedule that lists the devices which the manufacturer intends to cover in its Declaration.
The template is available: HERE
Clarifications
The Q&A clarifies some of its earlier statements, for example:
“A notified body letter informing about the expiry of the certificate, or a controlled phase-out of production agreed between notified body and manufacturer due to the expiry of a certificate prior to 20 March 2023, is not considered to be a withdrawal of a certificate.”
New Factsheet
The EU Commission has updated its MDR Factsheet, to reflect the later dates. It is available: HERE
The Factsheet is targeted at international regulators, to explain the extension. It may be helpful to manufacturers if they are struggling to show non-EU regulators that rely on EU marketing approval (e.g., Middle East, LatAm countries), that the expired CE certificate is still valid.
New Questions
The Q&A now includes the following:
- Does a national derogation granted in accordance with Article 59 MDR, or the application of Article 97 MDR, after 20 March 2023 trigger the extension of the transitional period?
- Can a device for which a derogation was granted in accordance with Article 59 MDR benefit from the transitional period even though it was required to not bear a CE marking?
- What happens if the application is withdrawn or the written agreement terminated?
- What is the impact of changes related to the manufacturer during the transitional period?
- Do legacy devices have to comply with UDI requirements during the extended transitional period?
