Marketing medical devices in the European Economic Area (EEA) can be a challenge as manufacturers must navigate changing regulations, 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.
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.
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 of the competent authorities work together in the CAMD network to support patient safety and organize the implementation and the enforcement of the regulations on medical devices and in vitro diagnostic devices.
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) and In Vitro Diagnostic Requirements (IVDR) 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 those that weren’t built according to harmonized EN standards, such as electronic equipment, gas appliances, and certain 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.
According to EU directive 2017/745 and 2017/746, 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 15223-1:2021
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.
A list of contact points for each of the authorities can be found on the European Union website.
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: