CE Mark extension is NOT Automatic
The EU MDR extension for certain medical devices only allows you up until 31st December 2027 or 2028 if you have a signed contract in place by 26th September 2024!
With several ‘extension of deadlines to MDR’, medical companies are interpreting that the regulatory authorities will freely grant an extension beyond 26th May 2024. But that is not the case!
Based on the information published by the European Commission - EXTENSION OF THE MDR TRANSITIONAL PERIOD – the commission published a Question and Answer Document followed by a Flow Chart, which answers several manufacturers' queries.
While manufacturers were going through the document and were busy navigating the specifications to check whether their device could benefit from the extension or not, they forgot to read - the manufacturer or the authorised representative must lodge a formal application for conformity assessment in accordance with Section 4.3, first subparagraph, of Annex VII MDR no later than 26 May 2024. Manufacturer and notified body must sign a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII MDR no later than 26 September 2024 to benefit from the extended transitional period.
This clearly states that Manufacturers/EU Authorised Representatives MUST lodge a formal application for conformity assessment of their devices to the EU MDR.
What to Do Now?
- Check whether or not the transitional arrangements apply to your device(s)
- Lodge an application for conformity assessment of your device(s) with a designated EU Notified Body no later than 26th May 2024.
- Ensure a signed, written agreement for conformity assessment is in place no later than 26th September 2024.
Contact Experts at Med-Di-Dia and get complete support to adhere with these transitional timelines. Drop an email – mdd@mddltd.com or fill out our web form - https://mailchi.mp/686b393380fc/bvmauwj29a
