Medical Devices Group

  • Community
  • Webinars
  • Jobs
  • Events
  • Contact
  • Go Premium
« Back to Previous Page
Antonia Trevisan
regulatory engineer presso Lima Corporate
August 2018
MDR: Are custom-made devices exempt from CE marking?
< 1 min reading time

I have a question on MDR implementation: Is it confirmed that custom-made devices are exempt from CE marking?

According to MDR art.20 par.1, and art.52 par.8, I believe that custom-made devices are exempt from CE marking.

Are there any conflicting interpretations or guidelines?

Thanks.

Marked as spam
Posted by Antonia Trevisan
Asked on August 7, 2018 4:49 pm
1609 views
  • Follow
  • Unfollow
  • Report spam

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

Private answer
Andrew Pacey

Think you find it is the same as with the MDD. You can use a custom-made device for a named patient and clinicals but it still has to meet the Annex I ER. You can not just print something in your office, wash it in ethanol and stick it in to the patient without the local approvals. Not saying it does not happen,,,,

Marked as spam
  • Report spam
Private answer
Antonia Trevisan

ok, it still has to meet the Annex I ER of course.
thanks so much

Marked as spam
  • Report spam
Private answer

Custom-made devices are far from exempt from the MDD, in fact there is a specific Annex (VIII) which covers the requirements.

Marked as spam
  • Report spam
Private answer
Robert Packard

Correct answer from Roland.:) He’s an experience NB auditor.

Marked as spam
  • Report spam
Private answer
Robert Packard

For the MDR, there is also an Annex specific to custom-made devices: Annex XIII. Although you are not required to place the “CE” on your product or label, as stated in Article 20, you are required to have a Declaration in accordance with Annex I. You are also required to undergo a conformity assessment procedure for Class III implantable devices in accordance with Annex IX, Chapter 1 or Annex XI, Part A (i.e., full quality system).

Another consideration is whether the device is actually “custom-made.” Many orthopedic devices are patient-matched, and they are not considered custom-made.

Rob Packard
https://medicaldeviceacademy.com
[email protected]

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.