EAR - European Authorized Representative Services
Finlink is based in Finland and proficient in providing services as European Authorized Representative to manufacturers of medical devices and Invitro Diagnostic Devices in obtaining regulatory approval to sell products throughout Europe. We assist manufacturers with a wide variety of regulatory and quality assurance requirements. For the organizations who do not have a physical location within the EU, European law for medical devices insists that the manufacturer must appoint a European Authorized Representative located in Europe to act as their representative with the Competent Authorities.
Finlink is an official EU Authorized Representative organization offering services to medical device manufacturers worldwide for the following:
- Acts as your primary contact point for all national Competent Authorities
- Registering your devices with the national Competent Authorities before they are marketed, where applicable
- Giving you authorization to place our name and address on your device labels, packaging and Instructions for Use
- Acting as interface between you and the Competent Authorities
- Maintaining a current copy of your Technical Documentation available for inspection by the European Competent Authorities
- Protecting the confidentiality of your documentation. And making them available to Competent Authorities as and when required by law
- Reporting incidents (if any) to Competent Authorities, in cooperation with you and your distributors (if contractually agreed)
- Representing you to the European Commission for consultation in case of withdrawal of a medical device by a Member State(s)
- Notifying notified by the Competent Authorities of serious device incidents
Free sale certificate
Having a CE mark entitles a manufacturer to enter the EU Market in all 28 EU Member States and 4 EFTA countries. CE Mark enables to sell in the European Market.
EU Regulations are considered quite effective and up to date as per the latest developments in the medical device applications in the patient care taking care of all the potential risks and putting highest level of efforts for making medical devices safe for their intended use.
Considering CE Marking as a bench mark, many countries globally, outside EU Market, now demand for CE marking for registration in their respective Ministry of Health.
Due to the high standards of health and safety required by the EU Regulations, customers in non-EU countries may request the manufacturer to provide a Free Sales Certificate to demonstrate the device meets the various safety and health requirements specified by the EU Regulations. This Certificate will enable the device to be registered in the market of the relevant country and be placed on to the market (considering all local requirements are also met, if applicable).
As the manufacturers from Non-EU countries cannot communicate with the Authorities, this FSC can be obtained only through the manufacturer’s legal entity in Europe, the European Authorized Representative.
Finlink provides services for obtaining Certificate of Free Sale / Medical Device Registration.
CE Marking device technical file
CE Marking/Device Technical File, Technical File / Technical Construction File or Device File: This is a comprehensive data compilation with information and documents detailing all aspects about your medical device to ensure that the device meets essential requirements as per the applicable directive(s).
The classification of the devices is as given below:
- Medical Devices Under Medical device directive 93/42/EEC amendment directive 2007/47/EEC
- Class I, Class Is, Class Im, Class IIa, Class IIb, Class III
- Invitro Diagnostic Devices under directive 98/79/EEC
- List A and List B
FINLINK can provide complete information and guidance in establishing the applicable harmonized standards and also
designing of technical file as per the conformity assessment procedure selected by your organization depending on the conformity assessment procedures applied to the Notified Body.