In our recent Navigating the Challenges of the Modernization and Expansion of EU Medical Device Regulations webcast, we fielded a lot of questions about regional Notified Bodies.
As such, I’d like to use this blog post to examine the role they play in securing CE (Conformité Européenne) marking for medical devices in Europe.
Unlike the United States, where the Food and Drug Administration oversees all pharmaceuticals and medical devices, the EU has two separate organizations: the European Medicines Agency (EMA) for overseeing pharmaceutical development and approval and CE (Conformité Européenne) marking for devices.
Requirements for CE marking are based on risk. For the lowest-risk medical devices (such as eyeglasses and tests for serum cholesterol), a company can declare that its product conforms to all applicable directives and add a CE marking without involving another party.
All medium- and high-risk products must be evaluated by an independent standards organization, called a Notified Body, which is certified by a country’s national competent authority (medical device regulatory agency) to assess and grant CE markings.
Certification from any single Notified Body, regardless of country of origin, is sufficient for all countries in the EU, the European Free Trade Association, and Turkey. Unfortunately, there is no centralized agency responsible for issuing CE marking, and such marking is not an authorization to sell a product. Instead, it is an indication that a product has been assessed and meets EU safety, health, and environmental protection requirements.
Standards vary by Notified Body, but, in general, relatively little data is needed to obtain a CE marking.
- For devices that are substantially equivalent to an existing product, a comparative literature review may be sufficient
- For certain low-risk class devices, companies can certify the device themselves based on a review of their quality system by a Notified Body
- Highest-risk devices almost always require human data, but trials need not be randomized & often evaluate safety but not efficacy
To view the list of Notified Bodies posted on the European Commission’s Directorate General for Enterprise and Industry website, click on the links below.
90/385/EEC Active implantable medical devices
93/42/EEC Medical devices
98/79/EC In vitro diagnostic medical devices
If you missed the webcast, feel free to download the slides and be on the lookout for an upcoming ebook on current EU medical device regulations. If you’d like to be alerted when the ebook is available, please leave your contact information in the comments section.