If you are a non-EU medical device manufacturer wishing to sell your products in the European Union, you need to appoint a European Authorised Representative (EAR). An EAR acts as your ticket or green card to place your medical devices in the markets of 27 countries of EU.
Every European Authorised Representative has to fulfill the roles and responsibilities that have been laid down under Article 11 of MDR 2017/745. These duties are:
Documentation
Verification of:
- Declaration of Conformity
- Technical Documentation
- Conformity Assessment Procedure
Retention for 10 years or 15 (implantable):
- DoC
- Technical Documentation
- Certificates+Amendments/Supplements
Vigilance
Forward immediately to the manufacturer:
- Requests by Competent Authorities
- Adverse events’ reports and complaints
Cooperating with Competent Authorities on preventive/corrective actions
Registration
Register in EUDAMED and verify that the manufacturer has met their registration obligations.
Free Sales Certificate
Though it is not explicitly mentioned in the Article 11 of MDR, an Authorised Representative is the only one who can apply for an FSC or Certificate of Free Sales for a non-EU manufacturer, which allows the latter to sell his devices in the EU.
Meddevices Lifesciences as a European Authorised Representative, not only fulfills its responsibilities as an EU EAR, but also goes a few steps ahead to offer some additional services to the medical device manufacturers.
Additional Services We Offer
LDR Review
LDR Review is conducted for legacy devices i.e. devices approved under MDD, to know how compliant they are to MDR 2017/745.
Clinical Evaluation – Literature Review
Published literature is searched and reviewed to establish equivalence to your device and to prove its clinical safety.
Product Testing
We provide medical device safety and usability testing services through our sister concern.
ISO 13485 E-DMS
An electronic platform to comply with ISO 13485:2016 Quality Management System and meet with its documents requirement.
Guidance in Drafting of EU DoC
Assistance and guidance in drafting an MDR 2017/745 compliant EU Declaration of Conformity (DoC).
Label and IFU Review
Label and IFU of the device is reviewed to ensure their compliance against the requirements laid down under MDR 2017/745
Not Just an EAR –
A Complete Support System Service for Your Medical Device!!
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