Why do you need an authorised representative in the European Union?
If you are a manufacturer outside the European Union (EU) and sell your products in the EU, the law requires you to have an authorised representative in the EU.
What is an authorised representative?
European law defines an authorised representative as somebody who:
- is designated by the manufacturer;
- acts instead of the manufacturer with regard to the manufacturer’s regulatory obligations;
- may be contacted by authorities and other bodies in the EU instead of the manufacturer.
The manufacturer must place the name and address of the authorised representative on the label of each device shipped to the EU.
In addition, the authorised representative can help the manufacturer with regulatory compliance, e.g. management of adverse incidents and dealing with enforcement issues.
Why should you choose Abnovo Ltd as an authorised representative?
Acting as an authorised representative is a very serious responsibility and is best entrusted to somebody who understands the European regulatory requirements and has significant practical experience in dealing with them.
AbNovo’s managing director, Mika Reinikainen, is a lawyer who has over 30 years of experience in European regulatory affairs. Mr Reinikainen is uniquely qualified to operate in Europe’s multicultural and multi-lingual environment. He is also the founder and Chairman of the European Association of Authorised Representatives. His network of partners can provide a multitude of services to a medical device manufacturer such as running clinical trials, developing and implementing quality systems and carrying out all the processes needed to obtain CE marking.
AbNovo’s unique approach of partnership ensures that the manufacturer’s regulatory and business objectives are fully taken into account. We will make a special effort to get to know the manufacturer’s products and key staff. AbNovo’s mission is to minimise regulatory risk to its clients in the marketplace.
What services does AbNovo offer?
The following are the basic authorised representation services offered to all Abnovo’s clients:
- A European address.
- Immediate analysis of any issues arising (suspected adverse incident, compliance query from authorities, etc.)
- National product registration.
- Periodic regulatory health assessments.
- Dealing with regulatory authorities across Europe.
These are basic services that will be provided to all clients. AbNovo’s ability to provide further services is very extensive. We therefore initiate our partnership by determining together your needs and putting together a customised package of services that specifically address your needs.
How much is it going to cost you?
The actual fees will depend on the nature and number of the products concerned as well as various risk factors. The fee structure consists of:
– An onetime initiation fee to set up the manufacturer as a client
– An annual retainer fee to cover routine basic activities
– Fees for any additional work done beyond the basic activities.
Interested in our services? Please contact us.