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European law requires medical device manufacturers, who do not have a physical location within the European Union, to appoint a single ‘Authorised Representative’ who is based within the EU. 

 

What is the role of an Authorised Representative?

Your authorised representative has a vital role, not just in maintaining your physical presence in Europe, but also importantly in:

  • Acting as your key contact with Competent Authorities in the EU
  • Registering your medical devices
  • Providing use of our name and address on your device packaging
  • Keeping your product know-how confidential and secure
  • Offering guidance on European compliance regulations relevant to your products
  • Assisting your distributors in incident reporting and follow up.

 

 

Actimed as Authorised Representative

 

Actimed has over 17 years’ experience in the medical device and healthcare field.  Our client base includes medical devices manufacturers large and small, both in the UK and internationally, covering Class I to Class IIb devices.

EC Representation through Actimed supports your business from initial registration of product right through to adverse incident reporting – all for a single annual low-cost fee. 

 

Advantages of using Actimed

Assurance

We are a UK-based, independent company, with experience in the medical devices industry since 1995 and qualified in EC representation, in accordance with Article 14 of the Medical Devices Directive 93/42/EEC.  With Actimed, you can be assured that the confidentiality of your documentation will be respected and protected.

 

Independence and confidentiality

Using a distributor as an authorised representative is widely practised and may seem a simple solution.  Authorised representation through Actimed provides medical device manufacturers with the confidence that they will be represented without conflict of interest – and that their representative has the regulatory expertise to guide them should a compliance issue arise.

 

Value for money

Actimed believes in taking a tailored approach to each client’s needs, so you get the level of service you need at a fraction of the cost of some of the larger consultancies on the market - you don’t pay more than you need to. 

We handle the whole registration process for you, with all costs shown up front, so no hidden fees.  And initial registration costs are included in your first annual fee.

Should your business need additional consultancy support, such as for quality and regulatory management training, system support or internal auditing, Actimed will offer special rates for these services to its authorised representative clients.

 

Please use our enquiry form to contact us so we can discuss your requirements with you.

 

 

We have used Actimed for many years as our Authorized Representative for MDD. Actimed is very knowledgeable with ISO standards and MDD regulations. They are very prompt in responding to our requests and requirements.’

Allen R Howes, President, TTI Medical, California, USA

 

 

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Copyright 2012 Actimed Limited, Registered in England CRO Registered No. 05717254.
Registered Office 9 Systems House, LS24 8LY, UK