10 THINGS YOU NEED TO KNOW BEFORE THE MDR: European Authorised Representative

Date of application of the new European Regulation (MDR) is coming inevitably. Today I will give you some useful details about an Authorised Representative mentioned in current directives and compare it to the new regulations concerning medical devices. Most of you have already heard about this economic operator, which can be called: EC REP, EU REP, Auth. Rep. or just Authorised Representative.

Importers and distributors from EU countries are one of the interested parties in having a good knowledge about the responsibilities of the Authorised Representative.

Employees from the EU medical devices companies, which I’ve spoken recently, told that have sufficient minimum information.

• “What is an Authorised Representative?” Maybe it can be a distributor, importer or different organisation, acts as a representative of non-EU Manufacturer.
• “What does this company do?” The first thing that comes to mind “This company is mentioned on labelling”. Several people said: “The company performs the registration activities”.

Maybe it can be sufficient for most of the cases. From the importer perspective I can tell that sometimes it's better to know more to safe the time and money. Manufacturers from non-EU countries, which has the EU REP only “on papers”, often don’t have a sufficient regulatory knowledge. Authorised Representative is a bridge, which can help to do regulatory issues and solve regulatory problems as soon as possible, without any delay. When you know what the EU REP can do, you know how to persuade the Manufacturer to act in some issues e.g., do some obligations according to MDR and have your products delivered on time.

Another, but not less important party is a Manufacturer from non-EU countries.

As a Manufacturer everyday you are dealing with the regulations from different parts of the world. Maybe today you are submitting the documents to FDA, tomorrow to ANVISA, and on the third day you are dealing with the PMDA requirements. You heard that in May 2021 everything will be changed in Europe. More work, more money to spend and delayed other projects. If you take a time to get to know about the competences and responsibilities of the EU REP, then you can safe your time and establish some new effective rules with your EU REP.

Getting to the point, everything you need to know about competences of the EU Authorised Representative (EU REP) according to new European Regulations concerning medical devices is right here. Take a moment to read and analyse 10 things you need to know about EU REP.

1. Does an EU REP have a registered address in one of the European Union member states?

Firstly, you should know something about an European Blue Guide. This is the Guide on the provisions applicable to all products in the European Union. The aim of this Guide is to explain these provisions and to interpret the European regulations properly, including medical device regulation. This guide describes that delegation should be set out in writing (agreement, mandate or power of attorney) to define contents and limits of tasks. Copy of the agreement should be available for Competent Authorities upon request.

Additionally, the EU REP should be subject to the European law to represent the Manufacturer, so should have its registered office in the EU.

It is worth to mention that an Authorised Representative is not the same as an Authorised Distributor or Agent.

2. What information should include the agreement between a Manufacturer and an EU REP?

• The agreement between the Manufacturer and the EU REP should be made in writing and define contents and limits of tasks.
• The Manufacturer should appoint the EU REP and the EU REP should accept the appointment in writing.
• The Mandate should cover at least all devices of the same generic device group provided by the Manufacturer.
• The Mandate shall at least specify the list of activities and tasks of the EU REP provided for to comply with the legal requirements (directive or new regulation),
• The Manufacturer shall not delegate to the EU REP any of the Manufacturer’s obligations, which are mentioned the Regulation, Article 10 (design and manufacture, risk management, clinical evaluation, PMCF, Technical Documentation (TD), Declaration of Conformity, UDI, QMS, PMS, CAPA, FSCA, Informative materials. Thus, the EU REP can help in any regulatory issues concerning these tasks.

3. Is an EU REP an independent organisation from an Importer or a Distributor?

The EU REP should be an independent organisation, which acting in agreement with the Manufacturer. You may have many distributors in your distribution network who are experts in sales and marketing, not necessarily in regulatory affairs. In case of problems in the distribution and related problems with legal requirements, the distributor will always defend himself. If you are considering appointing a distributor as an EU REP for your company, consider these issues:

• EU REP has access to the full TD, including information about the project,
• EU REP should be kept informed of any changes in legal regulations and should inform your company of the changes in advance,
• EU REP should be able to represent a Manufacturer adequately and answer all questions from Competent Authorities concerning manufactured medical devices,
• EU REP is appointed in all information materials: labels, packaging, instructions for use.

4. Does an EU REP have an experience and can monitor current legal regulations?

Monitoring and dealing with European regulations can be very challenging, especially right now, when all regulations are changing.

New medical devices regulation creates a lot of new regulatory work to do. Understanding new provisions can be a tricky business, if you are not familiar with the details.

A competent EU REP have enough competences and are always up to date with the regulatory issues, because they focus mainly on this, so you could call them an Expert in their work.

Choosing an EU REP for your medical device is a serious decision, one which will affect you for years. Careful consideration of the points above - your needs, EU REP’s experience, involvement and an individual approach. Each Manufacturer has different needs and problems to solve. Being always up to date with the requirements and use of tailored actions can be a key to a positive cooperation.

5. Does an EU REP have appointed a Person Responsible for Regulatory Compliance?

If you have read something about MDR or IVDR you know that you should appoint a Person Responsible for Regulatory Compliance (PRRC) as a Manufacturer. You should also know that an EU REP should also have the right competences to be your Representative, among others: four years of professional experience in regulatory affairs or in quality management systems relating to medical devices, because according to new legal requirements

“Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise”

which is similar to those for a Manufacturer's PRRC.

6. What are key responsibilities and tasks of an EU REP according to current directives?

First of all, in the current Directives there is no defined process or scope for designation of an EU REP. The EU REP should be appointed by Manufacturer and make available to Competent Authorities upon request the following documents: DoC, Documentation of QMS, Technical Documentation (TD), changes in TD. The EU REP should take part in the assessment of incidents with Manufacturer and Competent Authority.

7. What new responsibilities of an EU REP appear in the new medical devices’ regulations (MDR and IVDR)?

It is very important to emphasise that according to new regulations the EU REP plays a pivotal role in ensuring the compliance of the medical devices provided by Manufacturer.

• EU REP shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise.
• EU REP’s obligations include verifying the EU declaration of conformity and technical documentation and ensuring that an appropriate conformity assessment procedure has been carried out by the Manufacturer,
• EU REP shall keep copies available of all documents (technical and project documentation, certificates) and make them accessible to Competent Authorities on request.
• EU REP will have to verify that the Manufacturer has registered the requested information in EUDAMED,
• EU REP will have to cooperate with authorities on preventive and corrective actions, then inform the Manufacturer immediately about complaints and authorities’ requests for samples of devices.
• EU REP should be liable for defective medical devices together with the Manufacturer, if the Manufacturer has not complied with its obligations under the Regulations.

8. Does an EU REP appear on the packaging and labelling?

Yes. The EU REP (name, address and contact details) should be listed on the product label, packaging and Instructions for use. Additionally, the Declaration of Conformity should include the EU REP details.

9. Who needs an EU REP and an UKRP after BREXIT?

If you are a Manufacturer from the territory outside the UK and want to place a medical device or in vitro diagnostic medical device on the Great Britain market, you are obliged to appoint a UK Responsible Person (UKRP) – it is an equivalent to an EU REP in the UK territory.

From January 1, 2021 Manufacturers from the territory of UK should appoint an EU REP to export theirs medical devices to the EU market as they are no longer a part of the European Union.

10.  Which countries do not need an EU REP?

• All European Union Countries: Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden,
• The European Economic Area (EEA) countries: Iceland, Liechtenstein and Norway,
• The European Free Trade Association (EFTA) countries: Switzerland,
• Customs Union Agreement Country: Turkey.

Now you definitely know whats the function of the European Authorised Representative, its competences and activities. By creating this guide, I wanted to emphasise main issues in the cooperation with the EU REP on the one hand and main activities of the EU REP, which can help you to deal with Manufacturers from all over the world on the other.