Following the publication of the amendment in the Official Journal of the EU, Advena has updated the guidance document that was published last month. The document was updated to make reference to an important date, the date of entry of the amendment, which is stated to be 9th of July 2024. This date is importantas it will be used to distinguish which CE certificates can benefit from the extension. If the CE certificate expired before this date, then the manufacturer can still benefit from the extension, however, they would need to satisfy an additional criterion to make them eligible. Prior to the expiration of the CE certificate, a written agreement has been signed between the manufacturer and a notified body for the conformity assessment of the device, or the manufacturer has applied for an Article 54(1) or Article 92(1) derogation in respect of the device and the Competent Authority has granted the derogation.
Additionally, links to important documents that were released from last month were included in this updated guidance document, these includes the following;
- Published Legislation (EU) 2024/1860
- Self-Declaration Template
- Notified Body Confirmation Letter Template
- Q&A document released by EU Commission
- Gradual Roll-Out of EUDAMED Infographic
The updated guidance document can be accessed using the following link
