EU Authorised Representative: A Comprehensive Overview
If you want to sell medical devices into the European (EU) marketplace, you need to understand the role of an EU Authorised Representative. Our job is to act as the key person connecting non-EU manufacturers with European regulatory authorities making sure they follow EU rules.
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What does an EU Authorised Representative Do
If you're a manufacturer outside the European Union, you need an EU Authorised Representative to sell your medical devices in the EU market and comply to the Medical Device Regulations (MDR). The EU MDR regulation spell out the specific duties that are required of your EU Authorised Representative.
Scope of Representation
Your EU Authorised Representative has several key jobs. These include:
Verify your entry with the necessary regulatory body
Work with officials on preventative and corrective measures
Let you know right away about complaints and requests for device samples
Have an open line of communication with the person in charge of compliance within your organisation.
Legal Risks
Under the Medical Device Regulations, your EU Authorised Representative can be held responsible for faulty devices. This shared responsibility applies if you, a non-EU manufacturer, haven't met your duties under the rules. Your EU Authorised Representative must end their mandate if you act against your obligations
Keep in mind, that appointing an EU Authorised Representative is mandatory if you're a non-EU manufacturer planning to sell medical devices in the European Union.
Key Tasks Carried Out by Your Authorized Representative
As a manufacturer outside the EU, you'll see that your EU Authorized Representative (EAR) has a vital role to ensure your medical devices follow European rules. Let's look at the main tasks they do to help your products stay in the EU market.
Managing Technical Documents
Your EU Authorised Representative verifies your declaration of conformity (DoC) and technical documents . They'll retain copies of these documents, including any changes or add-ons, to show to the relevant authority when asked. This includes keeping these records for 10 years after the product hits the market, or 15 years for devices put inside the body.
Help with Conformity Assessment
Your EU Authorised Rep verifies that you have completed the right conformity assessment procedure. They look over and give the green light to labelling materials and usage instructions. Also, they help to prepare and turn in required technical docs to relevant EU authorities or Notified Bodies.
Incident Reporting
Your representative must tell you about any complaints or reports from healthcare professionals, patients, and users. Your EUAR will work with the relevant authorities on preventive and corrective actions and help with incident and Field Safety Corrective Action reporting alongside you and your importers/distributors.
Product Registration
Your EU Authorised Representative checks that you've entered the necessary details on the European Database on Medical Devices (if necessary).
Changes for UK manufacturers since Brexit
As a UK manufacturer, you'll face new hurdles to enter the EU market. The European Commission says UK-based economic operators no longer count as established in the EU. This means the EU might see your distributors as importers, with different duties than before.
New rules to enter the EU market
To keep selling your medical devices in the EU, you need to:
Choose an EU Authorised Representative based in the EU, this includes Northern Ireland.
Make sure your products follow EU rules, including CE marking.
Meet specific importer requirements if your EU distributor takes on that job.
It’s worth noting that your UK Responsible Person can't sign CE Declarations of Conformity for products entering the EU market anymore; it has to be your EU Authorised Representative. Fortunately, you can use a company like ours to enter both markets.
From July 2024, the UKCA mark replaced CE Conformity in the UK however it is not accepted in EU, EEA, or Northern Ireland markets. You still need CE marking for these markets, or a UK(NI) mark for Northern Ireland.
EU Authorised Representatives have a big impact on non-EU manufacturers who want to sell medical devices in Europe.
At Taylored Consultancy, we connect manufacturers with regulatory authorities. We make sure to comply with the EU regulations and facilitate market access. Our job includes managing technical papers and helping report incidents. This is key to navigate the tricky rules for medical devices in the EU.
Brexit has had an impact on the rules for medical devices making companies change how they work in both EU and UK markets. To stay in these markets and stay compliant, you need to appoint a committed and experienced EU Authorised Representative. To find out more, schedule an appointment.
