Ship & Print Your FDA eCopy
2 min reading time
One of my clients sent me an email this morning asking, which upcoming regulatory changes will affect the Declaration of Conformity (DoC) for CE Marking of medical devices. They also requested a link to the new EU legislations which will come into force next year.
The person was sending this email in response to downloading my template for a Declaration of Conformity from my website:
This link was at the end of my article on the subject of creating a Declaration of Conformity template:
The template was created using the requirements outlined in the proposed EU Medical Device Regulations:
In Annex III of the proposal, it defines the content of a Declaration of Conformity. We don’t yet know what the regulation number will be and not all manufacturers have UDI codes yet, but the template meets all the current requirements. The template is also designed to minimize the number of revisions that might be required in the future.
Here is a more comprehensive list of changes that might be required to the Declaration of Conformity:
1. Authorized Representatives have new responsibilities in the proposed regulations. Therefore, we may see some attrition of companies that are willing to take on these responsibilities, and you may need to change which company is identified in your Declaration of Conformity and on your product labeling.
2. UDI codes will need to assigned to all products that are CE Marked and the device identifier will need to be listed for each product on the Declaration of Conformity.
3. The risk classifications will change for many products due to reclassification plans and the Annex that defines the risk classification is changing.
4. The regulation will no longer be a New Approach Directive and the reference to the MDD will need to be updated.
5. The list of harmonized standards needs to be updated for all products and incorporated into the Declaration of Conformity.
6. Some of the Notified Bodies will not longer be able to CE Mark devices–especially high-risk devices. Therefore, you may need to switch one or more products to another Notified Bodies.
7. All certificates for CE Marking will need to be re-issued and the process for conformity assessment will have a new Annex (i.e., Annex VIII).
I would like to be able to provide a comprehensive list of all changes to the regulations, but this is impossible until the regulation is finished being revised and negotiated between the EU Council and Parliament.
As soon as the regulations are finalized, you can expect a new training webinar on the topic from me. I will also be teaching a workshop in the UK on the topic of 510(k) submissions and CE Marking on February 9, 2016. The cost is $799 per person.
Marked as spam
Meet your next client here. Join our medical devices group community.
Please log in to post questions.