Competent Authority, Notified Body, Authorized Representative – who’s who and what do they do?

Marketing medical devices in the European Economic Area (EEA) can be a challenge as manufacturers must navigate changing regulations (including the pending IVDR rollout next year), and an array of agencies across the region and in specific countries. Some regulatory activities require interactions with regional level authorities, while others are handled by Member States, and it’s not always clear when to engage with which authority.

government building

This article explains the different regulatory bodies that oversee medtech products within the European region, their roles in the market clearance processes, and a full list of relevant country-specific authorities.

 

Competent Authorities

A Competent Authority belongs to the government of a Member State of the European Union (EU) and is responsible for transposing the requirements of European regulations into national legislation. There is an umbrella group called the Competent Authorities for Medical Devices (CAMD) that is responsible for improving communication and collaborative work between these competent authorities, and increasing the surveillance of medical devices on the market. All competent authorities work together in the CAMD network to support patient safety and facilitate the implementation and the enforcement of the regulations on medical devices and in vitro diagnostic devices.

 

Notified Bodies

Medical devices are initially reviewed and approved by a Notified Body before they are placed on the market. Notified Bodies are supervised by the Competent Authority of a particular EU Member State. A Notified Body is an independent organization designated by an EU Member State to make sure that the Medical Device Requirements (MDR) are being followed for as long as the product remains on the market. Notified Bodies are also designated for specific directives, regulations, or products that need higher and stricter safety standards, or that weren’t built according to harmonized EN standards, such as electronic equipment, gas appliances, and medical devices.

A medical device that has been approved for the market will bear a “CE mark” which indicates that it meets the basic requirements for safety and effectiveness under European law. In addition, The Commission assigns a 4-digit code to each Notified Body, with the purpose of uniquely identifying each company that acts as a Notified Body. The codes range from 0001-2900, and they must be placed below the CE Mark on the product and/or it’s packaging, and on the user manual.

CE Mark

 

Authorized Representatives

According to EU directive 2017/745, it is a legal requirement to appoint a European Authorized Representative (EU Rep) for a medical device manufacturer who does not have a registered place of business in a particular EU Member State. This role will be the liaison between the manufacturer and the Competent Authority. The name and address of the EU Rep must be included on the labelling, outer packaging or on the instructions for use as designated in EN ISO 15223-1:2016.

Generally speaking, each Member States’ Competent Authority is responsible for monitoring the safety of medical devices after they are placed on the European market. They are given the authority to act on behalf of the government of an individual European Union Member State to ensure that the regulations are being monitored for compliance with the national statutes and regulations according to EU law.

 

EU National Competent Authorities

Competent Authorities for each of the EU Member States are listed below. For additional information and contact details, refer to the AKRN website.

Country
Competent Authority
Austria
Austrian Agency for Health and Food Safety
Belgium
Federal Agency for Medicines and Health Products
Bulgaria
Bulgarian Drug Agency
Croatia
Agency for medicinal products and medical devices of Croatia
Cyprus
Cyprus Medical Devices Competent Authority
Czechia
Ministry of Health Department of Pharmacy, Medical Devices Unit
Denmark
Danish Medicines Agency
Estonia
Health Board, Medical Devices Department
Finland
Finnish Medicines Agency
France
National Agency for the Safety of Medicine and Health Products
Germany
Federal Institute for Drugs and Medical Devices

Paul Ehrlich Institute

Greece
National Organization for Medicines
Hungary
National Institute of Pharmacy and Nutrition
Iceland
Icelandic Medicines Agency
Ireland
Health Products Regulatory Authority (HPRA)
Italy
Ministry of Health, Directorate General of Medical Devices and Pharmaceutical Services
Latvia
State Agency of Medicines
Liechtenstein
Office of Health / Department of Pharmaceuticals
Lithuania
State Medicines Control Agency
Luxembourg
Ministry of Health
Malta
Medicines Authority
Netherlands
Healthcare Inspectorate
Norway
Norwegian Medicines Agency
Poland
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal
National Authority of Medicines and Health Products
Romania
National Authority of Medicines and Medical Devices
Slovakia
State Institute for Drug Control and Medical Devices
Slovenia
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Spain
Spanish Agency for Medicines and Health Products
Sweden
Medical Products Agency
Switzerland
Swiss Agency for Therapeutic Products, Medical Devices
Turkey
Turkish Medicines and Medical Devices Agency, Ministry of Health
United Kingdom
Medicines and Healthcare Products Regulatory Agency (MHRA)

 

Managing regulatory complexity for European submissions and compliance

Deciphering agencies, and understanding when to engage with which authorities is only one of the complexities that medtech regulatory affairs professionals have to deal with. The new MDR and IVDR regulations have introduced new product registration, universal unique device identification (UDI), and standards and evidence requirements. At Rimsys, we’ve authored several ebooks to help regulatory affairs teams navigate these changes. For more information, check out:

Rimsys is a world-leading provider of Regulatory Information Management (RIM) software designed specifically for the medical device industry. Rimsys offers a suite of cloud-based regulatory affairs software solutions to simplify and manage global product registrations, standards, essential principles requirements, UDI requirements, regulatory documents, changing regulations and more.

www.rimsys.io