EU Representation
Representing non-EU based manufacturers in a successful EU Market entry and safeguarding their future across the entire community.
Learn MoreEU Product Registration
Ensuring compliance and registering products to be made available on the EU Market.
Learn MoreTechnical Documentation Review & EU Submissions
For your products to legally enter the EU Market and continue to circulate, you must have valid documentation.
Learn MoreEU Consultancy, Legal & Training
Find your way through a complicated EU marketplace with the support of a professional.
Learn MoreCareers at Obelis
Take the first step to a consulting career that helps build a safer Europe.
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We have provided compliance and consulting services for more than 3000 manufacturers in over 60 countries, helping them successfully introduce products to the European market.
Learn MoreContact Us
Our head office is in Brussels and we have a network of offices in 11 different countries including the US and Israel.
Learn MoreInternational Representatives
An experienced EU compliance representative is just a call or meeting away…
Learn MoreObelis International Offices (OIO) Network
Obelis International Offices are independent partners who are able to provide our clients with solutions in other global markets of their choosing.
Learn MoreNotified Bodies for Medical Devices

Notified Bodies play a key role in supporting manufacturers to place only safe and compliant medical devices on the EU Market. They help the manufacturers by carrying out conformity assessment procedures and grant conformity certificates to medical devices. There are certain expectations that a Notified Body must meet before being designated by the EU Authorities.
A key aspect of their role is to inspect the technical documentations of MDD Is/Im, IIa and IIb as well as review and approve Design Dossiers (for Class III devices) towards granting CE Certificates or EC Design Dossier Certificates. Manufacturers can consult the European Commission´s complete directory of Notified Bodies (available on the NANDO website).
Learn More:
- Scope
- Classification
- The Directive: MDD 93/42/EEC
- Technical File
- Authorized Representatives under the MDD
- Custom Made Medical Devices
- Clinical Investigation
- Kits
- Risks of Non-Compliance
Selecting the right Notified Body for your EU Compliance requirements can be a daunting task. Contact us for help in your Notified Body Selection needs!
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