Notes

European Authorised Representative<
European Authorised Representative
Any non-EU manufacturer of medical devices, who wishes to place his products on the European market, needs to appoint a European Authorised Representative (EAR) . An EAR, also referred as EC Rep, can be either a legal person or entity established within EU. The EAR is responsible for ensuring that the manufacturer has a lawful presence in the EU and fulfils all his duties and responsibilities as laid under MDR. The EU authorities will not contact the non-European manufacturer directly. An EAR acts as a link between the manufacturer and the European Authorities. A European Authorised Representative has the following responsibilities as laid down under MDR:


Provide a registered address in the EU to be mentioned on the device packaging
Keep and make available the updated technical documentation of the manufacturer’s products to competent authorities for inspection
Act as a contact link between manufacturer and European Commission
Register devices and apply for EU Free Sales Certificate
Ensure compliance with regulatory updates
Inform and coordinate with manufacturers in case of any incidents reported by users, patients or healthcare professionals
Terminate mandate if the manufacturer acts contrary to MDR

It is very essential to choose your European Authorised Representative carefully, since the address and contact details of an EAR have to be given on the labelling material and sometimes, also mentioned on the marketing material. In addition to this, it is also essential to choose your EAR wisely, since an Authorised Representative can be audited by the Competent Authorities. It is important that your EAR has laid down a good Documentation Procedure, so that he is ready for such audits by the Competent Authorities.

Generally, for non-European manufacturers, the most easiest and common choice for appointing European Authorised Representative is their distributor in the EU. However, the most sensible decision a manufacturer can take is, not to appoint his distributor as a European Authorised Representative. Though there are many reasons to favour this decision, one that easily comes to mind is the interest and focus of the distributor. As a distributor, the focus is generally on the sales and marketing of the medical device rather than on the regulatory affairs and duties of an Authorised Representative. In case, the European laws and guidelines are modified, the distributor may not always be well informed about the new changes, thus misleading the manufacturer on how these changes will affect his medical device. And IGNORANCE of Regulatory Affairs is VERY RISKY.

At Meddevices Lifesciences , we have a history of experience in providing European Authorised Representative services and keeping up-to-date with the rules and regulations of the European Union. Also, in addition to the general roles and responsibilities as an EAR, we also offer some additional services to our clients including product testing from our sister concern, clinical evaluation, templates for EU DoC and IFU, LDR review etc.



Free Sales Certificate
A Free Sales Certificate (FSC) , also known as the Certificate of Free Sales (CFS) , is a ticket to sell your device in the international market. An FSC is a proof that your device is eligible and approved to be sold in a country outside the origin country. Health Ministries and regulators of many countries demand a CFS from manufacturers wishing to export their products in their countries. FSC acts as a testament that the device is safe to be used in the country to which it is being exported. An FSC can be applied for any medical device that bears a CE Mark and is marketed inside the EU. The certificate of free sales can be used as a proof for:


Product Verification
Manufacturer Verification, and
Good Manufacturing Practices (GMP)

An FSC is a guarantee issued to the importing country by the exporting country about the authenticity of the manufacturer as well as his product. The European Authorised Representative of the manufacturer applies for a CFS with a European Competent Authority on behalf of the manufacturer. The process to apply for an FSC consists of the following 5 steps:


Prepare the technical file
Apply to a Notified Body for CE Certification OR Prepare EU DoC in case of class I devices
Appoint a European Authorised Representative and sign an EAR Agreement
The EAR will complete the EU registration of your medical devices
After the registration, the EAR can apply for a Certificate of Free Sales with the respective authority wherein he is located

Generally, the certificate is issued within 4-5 weeks depending upon the issuance authority.

Though a Certificate of Free Sales is a basic requirement for a manufacturer to sell his products in another country, sometimes, the Ministry of other countries might ask for a legalized copy of the Certificate. The legalization or apostle of the FSC is important because a legalised FSC acts as a proof of conformance with the regulatory system. It gives a surety that the medical device mentioned on the FSC has been evaluated for safe use and can be sold in the Europe without any restrictions. Legalization proves the genuineness of the certificate, and it becomes recognisable by the External Ministry of other countries as well. A Free Sales Certificate can be legalized by the following 3 institutes:


Chamber of Commerce
Ministry of Foreign Affairs
Relevant Embassy

Meddevices Lifesciences , acting as a European Authorised Representative, provides Free Sales Certificate from The Netherlands for medical devices. The FSC we provide is well accepted in the Egypt/Middle East and other countries.


EUDAMED Registration
EUDAMED is a European Database for Medical and In-Vitro Diagnostic Devices proposed by the European Commission. The aim of establishing this IT system was to ensure a strict and correct traceability of the medical devices within the European supply chain. Though EUDAMED registration is still not mandatory, the manufacturers are highly recommended to register themselves as actors and their devices. It is designed to increase transparency for the healthcare professionals as well as general public and coordinate information regarding medical devices on the EU market.

The EUDAMED is divided into 6 modules:


Actor Registration
Device Registration/UDI Registration
Notified Bodies & Certificates
Clinical Investigation & Performance Studies
Vigilance & PMS
Market Surveillance

Currently, only the first 3 are active out of the 6 modules.

The first module is for manufacturer registration. In this, the manufacturer’s information is added in the EUDAMED. The information is then verified by the manufacturer’s European Authorised Representative before it is validated by the Competent Authority. Once the registration is complete, the manufacturer receives a Single Registration Number (SRN). An SRN is required by the NBs for the conformity assessment procedure.

After the issuance of SRN, the manufacturer can register his devices in the EUDAMED using Basic UDI-DI and UDI-DI. In addition to registration of devices certified under MDR, EUDAMED also has provision for registration of legacy devices. A lot of information is required to register your devices in EUDAMED like :


Basic UDI-DI
UDI-DI and UDI-PI type
Information of EAR
Device Class
Trade names, models, reference/catalogue number
CE Certificate details
EMDN codes
Where the device is/or will be marketed
Device characteristics etc.

Though EUDAMED registrations do expire, they need to be continuously updated to maintain the current information in the system.

Meddevices Lifesciences , acting as a European Authorised Representative, performs both manufacturer as well as device registration in EUDAMED for medical devices certified under MDR as well as legacy devices i.e. medical devices certified under MDD.


European Authorized Representative

Homepage: ”https://www.meddevices.net/”