EU Authorized Representative

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EU Authorized Representative

Manufacturers based outside of the European Union are required to appoint an EU Authorized Representative prior to placing their medical devices or IVDs on the EU market.

Providing this Authorized Representative service is one of Specculo’s core specialties as your regulatory partner in the EU. Read on to find out more about what an Authorized Representative is, what their legal obligations are, and how Specculo may assist.

What is an Authorized Representative and why do you need one?

An EU Authorized Representative (AR), EC-REP, or medical devices EU Representative is a person or entity located within the European Union (EU) that is appointed by a non-EU manufacturer to act as its representative with respect to specific product groups. Whilst larger corporations may opt to appoint a subsidiary within the EU as their AR, many manufacturers look to third-party organizations that offer this service.

This representative takes responsibility for ensuring that the manufacturer complies with all relevant EU regulations, specifically Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in-vitro diagnostics (IVDR).

The requirement to appoint a medical device Authorized Representative is not a new one; the previous Medical Device Directives 93/42/EEC, 90/385/EEC, and 98/79/EC all require it. However, the AR’s legal obligations have changed as a result of the Regulations to increase the level of scrutiny on medical device companies.

Who appoints the EU Authorized Representative?

The EU Authorized Representative may only be appointed by medical device manufacturers based outside of the EU that wish to place their CE-marked products on the EU market.

If you are a non-EU manufacturer looking to sell your products in the EU, you are required to comply with a range of regulatory obligations. One of the key MDR requirements is to appoint an EU Authorized Representative who will act on your behalf and ensure that your products comply with the EU Regulations.

EU Authorized Representative: What is their role and responsibility?

Apart from being a legal requirement to appoint an AR, they also serve as a contact person established in the EU and play a pivotal role in ensuring compliance of the devices they represent. The obligations of the EU AR are laid down in Article 11 of both Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in-vitro diagnostic medical devices (IVDR) and include the below.:

Documentation Verification & Access

The AR verifies that your Declaration of Conformity and Technical Documentation have been drawn up, and that you have chosen the appropriate route of conformity. They will need permanent access to this documentation.

Registration

The AR verifies that the manufacturer has met their registration obligations. The AR must also ensure they meet their own registration obligations.

Vigilance & Communication

The AR cooperates and communicates with the competent authority in the EU country with respect to any adverse incidents or corrective actions which need to be performed. They also immediately inform the manufacturer if the receive reports themselves.

AR Mandate

The AR draws up and maintains a legal agreement with the manufacturer including terms of payment, termination, period and devices being covered. Both party’s obligations are typically discussed.

EU AR Verification Process

Find out more about the AR verification process.

EC-REP Mandate

Find out more about what the AR mandate should include.

How to Choose an Authorized Representative

Choosing the right Authorized Representative for your organization is a crucial first step in present and future regulatory compliance. It may be tempting to go with the cheapest solution you find, however, keep in mind that changing AR in the future may be tedious, depending on your situation. Here are a few things to consider when choosing your EU MDR Authorized Representative:

Experience & Regulatory Expertise

The AR must be experienced and knowledgeable of the EU requirements and should be able to guide you over the regulatory hurdles you may face. An experienced team will help you navigate you regulatory requirements effectively.

Responsiveness

Having an Authorized Representative that is able to reply to your critical queries within a reasonable timeframe is crucial in situations in which a delayed reply could lead to a nonconformity or recall. A quick response time may also help you sleep better at night!

Cost VS Quality

Authorized Representative organizations typically charge on an annual basis. On top of this, there may be additional charges based on the number of devices you place on the market and their risk classification. Also, beware of organizations that charge by the hour, even for the quickest of calls or email queries. Finding the right balance between cost and service quality may be difficult. Just ensure that pricing is transparent from day 1 and that you understand what you’re paying for.

Common Mistakes to Avoid

Based on what we hear from clients, here are a few common mistakes which should be avoided:

Inadequate vetting of Authorized Representatives: Once you have a shortlist of potential ARs, it may be tempting to go with the cheapest option. Instead, have a conversation with each and understand their experience and the way in which they work. It will also give you a good indication of how future correspondence will be like.

Not understanding your AR’s obligations: An EU Authorized Representative which does not comply with its own obligations can negatively affect your business. You should have a good understanding of what they should be doing and question them when you think they are slacking.

Lack of clear communication: Just like any successful relationship, communication with your EC-REP will be key. Not being transparent with them (and they with you) can cause all kinds of regulatory heart ache. Make sure that you are clear with your intentions in placing product on the EU market.

Ignoring post-market responsibilities: Placing product on the EU market is only the first step. You need to monitor and continuously comply with your regulatory obligations in the post-market phase to maintain your place on the market.

Transitioning to a New AR

Thinking of switching AR? Click here to find out more about the transition process.

Why choose Specculo?

We are committed to providing our clients with the highest level of support and guidance as they navigate the complex landscape of EU regulations.

We pride ourselves on offering a personalized service that is tailored to our client’s unique needs, and we work closely with them to ensure that their products are fully compliant with all relevant EU regulations. By choosing us, you can trust that you will have a dedicated team by your side every step of the way.

We specialize in providing non-EU manufacturers of medical devices and IVDs with a reliable and cost-effective solution for appointing an EU Authorized Representative and ensuring compliance with EU regulations.

The following perks are included in our annual AR package:

Specculo's EU Authorized Representative Service Bundle

What you get with Specculo

Connecting you to the EU market, hassle-free.

Responsive

Reliable support when you need it most.

Expertise

Compliance without complexity.

Fast lead times

Efficient solutions, delivered quickly.

Simplify your compliance workflow.