Do I need an EAR if I have a Notified Body?
Though both are involved in the EU Compliance process and CE Marking, a European Authorized Representative and a Notified Body are not mutually exclusive bodies. Both have roles unique to themselves throughout the EU Compliance procedure. In order to clear up a few common misconceptions regarding European Authorized Representatives (EAR) and Notified Bodies (NB), this blog will outline the definitions and roles of each in order to better further the understanding of what is required from manufacturers of certain medical devices.
As we outline this, it is important to keep in mind that neither body, by law, is permitted to carry out or perform the duties of the other. As such, in certain circumstances, both bodies must be nominated and appointed independently of the other.
I. Notified Body
A Notified Body is the conformity assessment body appointed by the European or relevant national authority to ensure all conformity related procedures are adhered to in relation to products being sold within the European Market. Under EU harmonization laws, a third party is required to implement this type of procedure. As a result, a Notified Body is mandatory for manufacturers distributing class IIa, IIb, and III medical devices within the European Union.
The role of a Notified Body includes:
- Carrying out conformity assessments
- Issuing certificates (including CE Certificates)
- Performing surveillance audits
At no point is a Notified Body permitted to provide any consultation services.
II. European Authorized Representative
An Authorized Representative is any person naturally or legally established in the European Community who is explicitly designated by the manufacturer to act on their behalf. The Authorized Representative (EAR) acts as the body addressing/being addressed by authorities and bodies within the Community in lieu of the manufacturer themselves under medical directives MDD 93/42/ECC, IVDD 98/79/EC and AIMDD 90/385/EEC as well as all the other directives requiring placing a CE Mark on the product.
Depending on the conformity assessment procedure and the Union harmonization act in question, the role of a European Authorized Representative includes:
- Providing the manufacturer with a registered address inside the European Union
- Affixing the CE marking and Notified Body’s number to the product
- Conducting the Notification process and national registrations
- Ensuring full labelling compliance and linguistic requirements are met
- Keeping the Declaration of Conformity and Technical Documentation inside the European Union and available to all relevant competent national and international authorities
- Keeping all conformity documentation inside the European Union and available to all relevant competent national and international authorities
- Cooperating with the competent national authorities, at their request, on any action taken to eliminate the risks posed by products covered within their mandate
- Taking care of incident reporting and complaint handling
- Advising on the European Regulatory Strategy
- Providing ongoing regulatory news and updates
Manufacturers located outside of the EU are required to appoint a European Authorized Representative, no matter what the classification of their devices is. As already pointed out, Notified Body is a separate legal entity, which cannot fulfil this role.
Established in Brussels in 1988, Obelis Group provides European Authorized Representative and CE Marking advisory services. If you wish to learn more about the nature of the role of the Authorized Representative, or wish to get a free quote, do not hesitate to contact Obelis regulatory consultants today.