EAR - European Authorized
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.
Finlink can provide consulting services for various medical device approvals in europe as well as outside europe with special focus on regulatory aspects and requirements. We have tema of experts having good knowledge and expertise in medical device conformity assessment procedures as applicable.
We provide consulting solutions with special focus on
- Ce marking requirements
- Us fda 5109(k) with 21 cfr 820 requirements
- Iso 13485:2003 quality management system-medical devices, requirements for regulatory purposes
- Compliance to applicable product standards
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.
ISO 14971 Consulting
As part of obtaining CE marking for medical devices and invitro diagnostic devices, the manufacturers have to perform risk assessment and risk management process to ensure all the risk related to the medical devices are identified, evaluated, risk control measures taken and risk are within acceptable limits.
This process is very important to ensure that the devices are safe for their intended use.
FINLINK offers comprehensive services for the risk assessment and risk management by helping you in
- Identifying the risks (seen, foreseen and foreseeable)
- Evaluation of the risk
- Acceptability of the risk
- Risk control measures/methods
- Evaluation of residual risks after risk control measures adopted
- Concluding whether the device has become safe for its intended use or not
Our Team of experts has successfully done risk assessment and risk management process for many kind of medical devices starting from class I till Class III of Medical devices and List A, List B of Invitro Diagnostic Devices for Non-EU manufacturers.
Medical Devices in Australia are assessed by TGA (Therapeutic Goods Administration) of Australia.
For medical devices to be supplied in Australia, the device must be included in the Australian Register of Therapeutic Goods (ARTG) which is regulated by the Australian Therapeutic Goods Administration (TGA).
FINLINK can help you register your medical device or IVD with the TGA so you can start exporting your products into the Australian market
Organizations that have already obtained the European CE Mark for their medical devices, for them, the process of obtaining TGA approval can be comparatively easy as Australia recognizes the CE Marking under MRA with EU. However, even if the medical device or IVD has CE Marking, it must still be registered with the TGA and prior approval is mandatory prior to placing the devices on to the Australian Market.