Advena’s EU Authorized Representative Service goes beyond the obligations of European Medical Device Directives and associated EU guidelines, to provide professional advice and vital regulatory news updates.
We support the European Commission’s Medical Device Directives requirement for non-EU based manufacturers to allow them to designate Advena as their single Authorized Representative within the European community.
Our service conforms to EU guidelines MEDDEV 2.5/10 and includes:
- The legal obligations of the three European Medical Device Directives.
- The use of formal agreement Mandates followed by a Letter of Designation each year of service.
- Preparing Registrations for Class 1 and IVD device manufacturers with the UK Medicines & Healthcare Products Regulatory Agency (MHRA) or the Malta Competition and Consumer Affairs Authority (MCCAA).
- Obtaining Certificates of Free Sales for contract clients
As required by these EU regulations, Advena employ qualified individuals who possess the necessary expert knowledge on regulatory requirements for medical devices. This knowledge is supported by academic qualifications and professional experience in regulatory affairs and quality management relating to medical devices.
This service has been developed over many years to specifically support the needs of small and medium-sized manufacturers and distributors. Each contracted client is provided with up to 30 minutes free consultation each month for advice on quality systems, technical files, labelling, vigilance and reporting, registrations, product testing, etc.
Clients also receive regulatory news reports by email which we understand have been regarded as an invaluable means to keep up-to-date with the ever-changing regulations and standards.
Following the decision for the UK to leave the European Union – referred to as ‘Brexit’ by the media – we are able to assure all clients, existing and new, that Advena will continue to lead by being a prominent English speaking international medical device consultancy uniquely based in the UK with a subsidiary office in Malta for EU registrations. For further information, please see our Brexit information portal >
Appoint Advena as your EU Authorized Representative – contact us today for further information.
Telephone: +44 (0) 1926 800 153