Medical Devices Group

  • Community
  • Webinars
  • Jobs
  • Events
  • Contact
  • Go Premium
« Back to Previous Page
Rob Packard
Ship & Print Your FDA eCopy
December 2015
What EU Regulation changes will affect your Declaration of Conformity?
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:

http://medicaldeviceacademy.com/medical-device-academy-declaration-conformity/

This link was at the end of my article on the subject of creating a Declaration of Conformity template:

http://medicaldeviceacademy.com/medical-device-academy-declaration-conformity/

The template was created using the requirements outlined in the proposed EU Medical Device Regulations:

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52012PC0542

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.

http://medicaldeviceacademy.com/ce-marking-workshop-and-510k-submissions-workshop/

source: https://www.linkedin.com/groups/2070960/2070960-6080400940643479553

Marked as spam
Posted by Rob Packard
Asked on December 9, 2015 8:00 am
422 views
  • Follow
  • Unfollow
  • Report spam

Meet your next client here. Join our medical devices group community.

Private answer
You continue to add such great value here, Robert, and I know it's paid off for your business. I invite other group members to learn from your example!

On a side note, we already have a few registrations for your workshop at 10x.
Marked as spam
  • Report spam
Private answer
Karen Boyd, ASQ CQA Thanks for sharing, Robert!
Marked as spam
  • Report spam
Private answer
Hema Lakkaraju Thanks for sharing
Marked as spam
  • Report spam
Private answer
Olivier Varomme Thanks for this interesting post
Marked as spam
  • Report spam
Private answer
Thanks very much. I'm new to this group and I look forward to learning more.
Marked as spam
  • Report spam
Private answer
Hi Robert cant seem to access your DOC template? Gives me no submission code.
Marked as spam
  • Report spam
Private answer
Devendra Aher PMP® Many Thanks Robert.
Marked as spam
  • Report spam
Private answer
Thanks for this information.
Marked as spam
  • Report spam
Private answer
Thanks!
Marked as spam
  • Report spam
Private answer
Steven Maier Great information as always Robert
Marked as spam
  • Report spam
Private answer
Hi Robert, thank you for your detailed information, as usual! I've been to a course on the MDR proposal this morning and we are all worried about the proposed changes...will see! See you to the next post, bye bye.
Marked as spam
  • Report spam
Private answer
Great job! I really appreciate that.
Marked as spam
  • Report spam
« Back to Previous Page

Please log in to post questions.

  • Go to WP login page

Stay connected with us.

By signing up you are agreeing to our Privacy Policy.

Categories

  • Capital/Investment
    • Business Model
    • Funding
  • Careers
  • Design/Devel
    • Design
    • Development
    • Human Factors
    • Labeling
    • Material Selection
    • R&D
    • Trials and Post-Market
  • Featured
  • Industry
    • Announcements
    • Device Tax
    • Hospital and Health Care
    • Innovation
    • Medtech
  • LinkedIn, etc.
  • Markets
    • Africa
    • Americas
    • Asia
    • Australia
    • Europe
  • Regulating
    • CE Marking
    • EU
    • FDA
    • FDA/EU etc.
    • Notified Bodies
    • Quality
    • Regulatory
  • Selling
    • Distribution
    • Intellectual Property
    • Marketing/Sales
    • Reimbursement
  • Worth bookmarking!
Feature your job here.
logo

Companion to LinkedIn's 350,000 member community

  • Contact
  • Medical Device Marketing
  • In Memoriam
  • Medical Device Conference

The Medical Devices Group   |   Copyright © Terms, Conditions & Privacy

Medical Devices Group
Powered by  GDPR Cookie Compliance
Privacy Overview

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.

Strictly Necessary Cookies

Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings.

If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.