european authorized representative
European Authorized Representative services for medical devices and in-vitro diagnostics
The Medical Device Regulations (MDR – Regulation (EU) 2017/745 & IVDR – Regulation (EU) 2017/746) – as the existing Medical Device Directive MDD 93/42/EEC and the IVDD 98/79/EC require the designation of an Authorized Representative (EAR) for those legal manufacturers who are based outside the European Union. The EAR must be based within the EU. The relevant legal requirements are described in both regulations in article 11. MT Promedt Consulting GmbH is acting since 1995 as a reliable European Authorized Representative under the Medical Device Directives 93/42/EEC, IVDD 98/79/EC and AIMDD 90/385/EEC and is providing qualified and professional EAR services in all EU Member States. Our services will support your company to comply with the new European regulations and is opening your access to the European medical device market in the future. The EAR is a registered economic operator.
Our EAR services under the new regulations will include:
- provision of authorized European address
- verification activities regarding EU declaration of conformity, technical documentation and appropriate conformity assessment procedure
- keeping available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued by the notified body
- verification of compliance with all registration obligations for the EAR and manufacturer
- interaction with competent authorities
- liaison between competent authorities, manufacturer, importer, distributor in vigilance aspects
- cooperation with the competent authorities on any preventive or corrective action taken to eliminate or mitigate the risks posed by devices;
- information of the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected product related incidents
All our clients have permanent and safe access to our document server system. Make use of our personalized EAR services. Our EAR services meet the requirements of the new regulations and provide you full flexibility in your European distribution network.
MT Promedt Consulting offers a complete consultancy service for medical device manufacturers. Your business is our business. So whether you need first ideas or a second opinion: we’re here to listen – and ready to answer.