Medical Devices
When is an EU Authorized Representative (EC REP) required?
The European Union requires any foreign manufacturer who intends to sell their medical devices in any of the Member States to designate a sole authorized representative (EC REP) with a physical address within one of the Member States. IGM will represent your company to the national authorities and shall register your devices in the electronic system before commercialization.
IGM acts as an authorized representative under the MDD/MDR and IVDD/IVDR. With the introduction of the MDR and IVDR, the authorized representative is considered an economic operator and shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer
What is the role of an EU Authorized Representative (EC Rep)?
Article 14 (2) of the medical device directive states; “Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representative in the European Union.”
Therefore for manufacturers of medical devices who can be accurately described by the above, it is a legal requirement to appoint a European Authorised Representative.
A European Authorised Representative may also be known as a EUAR, EC REP, CE REP, EU REP and also an EAR. All of these mean the same; EU Authorised Representative.
Your European Authorised Representative (EC Rep) provides a point of contact between you (the non-European medical device manufacturer) the national Competent Authorities (Ministry of Health) and Notified Bodies.
In addition as your EC Rep IGM will:
-
Operate in accordance to MEDDEV 2.5/10 Guideline for Authorised Representatives
-
Carry out applicable device registration with the national Competent Authority.
-
Provide, if requested, a cursory regulatory review of your artwork and product labelling.
-
Keep on file a copy of your full technical documentation for inspection by EU regulators, upon request.
-
Provide assistance with vigilance and Field Safety Corrective Actions (FSCA) reporting in accordance with MEDDEV 2.12/1 Rev 8
-
Provide regulatory news and updates via our free, monthly client newsletter.
The name and address of the Authorised Representative must be included on your labelling, outer packaging or the instructions for use (IFU). You must also use the EC Rep symbol as designated in EN ISO 15223-1:2016.
Under the new MDR (EU) 2017/745 Authorised Representatives (EC Rep) have greater responsibilities and take on significantly more risk and liabilities, therefore you can expect your representative to scrutinise your documentation more thoroughly.
EU Device Registrations
One of the roles and responsibilities of an EU Authorised Representative (EC REP) is to register devices on behalf of the manufacturer. Therefore, subject to receiving the appropriate fees and documentation your Authorised Representative will register medical devices and/or in-vitro diagnostic medical devices (IVD’s) with a national Competent Authority.
Devices falling under the following classifications must be registered:
-
Class I
-
Class I Sterile
-
Class I Measuring
-
Article 12 Procedure Packs/Kits
-
Custom Made Devices
-
All IVD’s (Including Annex II List A or B)
Under the new regulations (MDR) the newly added classification, Class I re-useable surgical instruments will require registration as such and re-classified IVD’s under the IVDR Class A, B, C & D will also require registration with a national Competent authority.
Technical Documentation Review & Verification
The new EU Regulations on medical devices and in-vitro diagnostic medical devices (IVD’s) require that the Authorised Representative verifies and checks that the technical documentation relating to a Medical Device, or an In-Vitro Diagnostic Medical Device, complies with EU regulatory requirements before it is placed on the market.
In the case of our EU Authorised Representative service it will be a legal requirement for us, if we are your EU Authorised Representative, to verify that the technical documents has been drawn up, and where applicable, that an appropriate conformity assessment procedure has been carried out, and that they comply with legal requirements. It is important to note that we will also be obliged to have access to manufacturers’ technical documentation at all times.
Therefore, a non-EU manufacturer of medical devices or IVD’s will be required to submit their technical documentation to their EU Authorised Representative for verification before the CE mark is applied and, importantly, before the Authorised Representative Mandate is a legal contract.
To have your documentation verified by IGM as competent consultants, whether you are an Authorised Representative client or not, will assist you in meeting your product liability requirements which are now so important.