17.12.2024
To the attention of interested persons
The European Commission launched on its website (https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14155-EU-rules-on-medical-devices-and-in-vitro-diagnostics-targeted-evaluation_en) a request for participation in public consultation for the purpose of targeted assessment of EU regulations for medical devices and in vitro diagnostic medical devices.
The results of the consultation will contribute to the evaluation of:
• the efficiency, effectiveness and proportionality
• meeting current and emerging needs
• the alignment with other European actions
• the added value at EU level of MDR and IVDR regulations.
At the same time, the European Commission has intensified its efforts to provide the necessary implementation tools.
The most recent updates and completions of the framework required for MDR and IVDR implementation are posted on https://health.ec.europa.eu/medical-devices-sector/new-regulations_en: regulations for the application of MDR and IVDR, guides and brochures for all interested parties, for clarification and support in the correct understanding and enforcement of legal provisions, as well as links to templates of documents imposed by the legislation and prepared by European professional associations in the field for manufacturers and other dedicated market actors:
• Q&A Extension of the IVDR transitional periods
• Templates for the IVD manufacturer statement during the transition period on the MedTech Europe website
• Template for written agreement and issued by a notified body (Template for notified body confirmation letter endorsed by NBCG-Med)
• Q&A Obligation to inform in case of interruption or discontinuation of supply
• The form for reporting an interruption or termination of the manufacturing process of a medical device (MDCG 2024-16: Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices)
• Device identification table (MDCG 2024-16 Annex: Device Identification table)
We also invite you to consult the page dedicated to guidelines (orientation documents) for the implementation of MDR and IVDR (https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en), which have recently been updated by the MDCG) and especially those for:
• Applying the provisions of MDR legacy devices: MDCG 2021-25 Rev.1, Application of MDR Requirements to “Legacy Devices” and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC (https://health.ec.europa.eu/document/download/cbb11a6e-f0f3-4e30-af5e-990f9ef68bc1_en?filename=md_mdcg_2021_25_en.pdf)
• Guidance on qualification of in vitro diagnostic medical devices 2024-11 (https://health.ec.europa.eu/document/download/12b92152-371f-404d-a865-93800cd5cdca_en?filename=mdcg_2024-11_en.pdf)
• MDCG 2024-14, Guidance on the implementation of the Master UDI-DI solution for contact lenses (https://health.ec.europa.eu/document/download/c8c6cca5-460e-410e-a325-be08bfc7dea6_en?filename=mdcg_2024-14_en.pdf)
• Regulation requirements for ethylene oxide, MDCG 2024-13, Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices (https://health.ec.europa.eu/document/download/3fa74c6b-953a-41f5-b024-8889ac8b5ddf_en?filename=mdcg_2024-13_en.pdf)
• Borderline between medical devices and medicinal products, MDCG 2022-5 rev.1, Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices (https://health.ec.europa.eu/document/download/b5a27717-229f-4d7a-97b1-e1c7d819e579_en?filename=mdcg_2022-5_en.pdf)