Eclipse Medtech - your Authorised Representative in Europe
All manufacturers of medical devices who are based outside of the European Union (EU), and who place their devices on the market within the EU, require a European Authorised Representative (AR).
The EU Medical Device and In Vitro Diagnostic Medical Device Regulations (2017/745 and 2017/746) define an AR as any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation.
The general obligations of an AR include the following:
- Reviewing and keeping a copy of the technical documentation/technical file, declaration of conformity and any CE certificates.
- Provide responses to and facilitate communication with EU Competent Authorities, including arranging access to samples of the devices.
- Inform the manufacturer of complaints and suspected incidents regarding the devices.
Why appoint Eclipse Medtech as your Authorised Representative?
We are a team of medical device regulatory consultants
This means that we can review your technical files efficiently and effectively to demonstrate compliance without suggesting unnecessary changes to documents.
We have a wealth of experience working with the HPRA and a range of other countries’ competent authorities so we can communicate with them effectively on your behalf, reducing the risk of the devices being taken off the market inappropriately.
Our parent company, Insight Regulatory Consultancy Ltd, provides a range of regulatory affairs, quality assurance and design and development services through one contact.
We also provide a UK Responsible Person service
Our parent company based in the UK, Insight Regulatory Consultancy Ltd, also provides a UK Responsible Person service, so you can access both the EU and UK markets through one contact.
We are based in Ireland
Since the UK left the EU, Ireland is seen by many as the gateway to Europe, due in part to it being the largest member state where English is the primary language.
In addition, the competent authority for medical devices in Ireland, the Health Products Regulatory Authority (HPRA), is the largest predominantly English-speaking competent authority in Europe. It is important to remember that, for medical device manufacturers based outside of the EU, the competent authority of the country in which the AR is based effectively becomes the competent authority for the manufacturer. Having a large competent authority that communicates and provides guidance primarily in English therefore has strong advantages should any issues arise. Competent authorities in smaller countries often do not have sufficient expertise in a range of issues to make pragmatic decisions and so are more likely to take a risk-averse and inflexible approach.
We provide one fixed price
The price we quote is the cost that you will pay for the AR service, no hidden costs for reviewing technical files or communicating with authorities. Our prices are also very competitive and are based on the number of types of medical device covered.
If you would like more information on our AR service, then please contact us.
If you would like more information on our AR service, then please give us a call or contact us using the form.