Regulatory Newsletter - Edition 19

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EU

The European Parliament has published a resolution on the urgent need to revise the medical devices regulation. This comes in response to the challenges that are being encountered in implementing the MDR and IVDR, especially for SMEs. These challenges present the risk of medical device shortages and interruption to healthcare access in the EU. The Commission is being called on to propose delegated and implementing acts to the MDR and the IVDR by the end of Q1 2025 to address the issues that are being encountered to ensure the continued availability of devices.

Team NB has issued a press release sharing their views on the implementation of the MDR and IVDR requirements. The main comments from the paper are as follows:

• consolidation of data review among different processes where duplication of data can occur, e.g. the data between PSUR, PMC(P)F, C(P)EAR. Reducing the requirement to review multiple instances of the same data would save time and money.
• broader use of common specifications, especially in relation to clinical evidence
• use of IT tools in the conformity assessment process to allow notified bodies to assess data, rather than documents
• increased financial support to SMEs
• adoption of a fast-track approach to the conformity assessment of breakthrough and life-saving products.

The European Commission has published the results of the 10th notified survey with data from up to 30th June 2024. Responses were received from all 50 MDR and 12 IVDR designated notified bodies, providing a 100% response rate. The survey gives an overview of the number of applications that have been received, the number of agreements signed, and certificates issued. As of June 2024, there have been 26,185 MDR applications filed, with 8,905 certificates granted. In relation to IVDR, 1,747 applications have been received, with 940 certificates granted.

The European Commission has released a Q&A document on the Regulation 2024/1860 provision to inform in the case of interruption or discontinuation of the supply of medical devices and IVDs. The document is split into 3 sections covering:

• general aspects of the requirement,
• manufacturers' obligations, and
• other economic operators' obligations.

MDCG 2023-3 has been updated to revision 1. The guidance which takes the form of a Q&A on vigilance terms and concepts has been expanded to include IVDR within its scope, along with MDR. Updates have been made throughout to include IVDR related text and examples.

MDCG 2024-13 has been released on the regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices. This guidance provides clarification on the use of EtO and confirms that while EtO is not subject to MDR/IVDR conformity assessment, the sterilisation and validation processes in which EtO is used, do fall within the scope of the regulatory requirements.

MDCG 2021-25 on the application of MDR requirements to legacy devices has been updated to revision 1. Updates to this version include:

• Alignment to MDCG document structure
• Alignment with transitional provisions of Regulation 2023/607:
• Non-applicability of MDR Article 19 to legacy devices,
• Application of transitional provisions to systems and procedure packs
• Requirement to implement a QMS according to MDR Article 10(9)

MDCG 2022-5 on guidance on borderline between medical devices and medicinal products has been updated to revision 1 to include products specifically intended for the cleaning, disinfection or sterilisation of medical devices as an example in Section 1.2.6.1 of the guidance.

EN ISO 308-1:2024 on "Aseptic processing of health care productions - Part 1: General requirements" has been added to the list of MDR harmonised standards.

Rest of World

MHRA has published a press release announcing that a post-market surveillance statutory instrument has been laid in parliament. The draft legislation includes a new Part 4a on post-market surveillance requirements. The provisions of Part 4a largely align to those of the EU MDR and IVDR. Once the parliamentary processes have concluded, the SI proposes a 6 month implementation period, meaning the provisions could become law by Summer 2025.

TGA has implemented an amendment to allow for the acceptance of US 510(k) clearances along with an MDSAP certificate to support class III medical device applications in Australia.

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