Approval of medical devices in Europe - A guide for manufacturers
The approval of medical devices in Europe is regulated by the Medical Device Regulation (MDR 2017/745). This regulation replaces the previous Medical Device Directive (MDD 93/42/EEC) and the Active Implantable Medical Devices Directive (AIMDD 90/385/EEC). Manufacturers who wish to place their products on the European market must fully comply with the MDR requirements and obtain a CE mark for their products.
This guide provides a comprehensive overview of the requirements for the approval of medical devices in Europe.
General overview of the medical device market in Europe
Population size
The European Union currently comprises 27 member states with a total population of around 448 million people. The European Economic Area (EEA) and other countries such as Switzerland and the United Kingdom follow some of the same or similar regulations.
Market volume
- The European medical technology market is one of the largest in the world and is estimated to be worth over 140 billion euros.
- Europe accounts for around 27 percent of global medical technology sales.
- Germany, France, Italy, Spain and the United Kingdom account for over 70 percent of the European market.
Forecasts for the next three years
- The industry is growing at a compound annual growth rate (CAGR) of 4 to 6 percent.
- Key drivers of growth are digitalization, artificial intelligence, robotics and personalized medical products.
- The introduction of MDR 2017/745 has increased the requirements for manufacturers, which has led to delays in the approval of new products.
Competent authority for medical devices in Europe
Medical devices in Europe are regulated at EU level, with the European Commission playing a central role.
Regulatory authorities and their tasks
- European Commission: Develops and updates the regulatory requirements (e.g. MDCG guidelines).
- Notified Bodies (NB): Test and certify medical devices according to MDR 2017/745.
- National authorities of the EU member states: Monitor compliance with MDR regulations at national level.
Examples for national authorities
- Germany: Federal Institute for Drugs and Medical Devices (BfArM)
- France: Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM)
- Italy: Ministero della Salute
- Spain: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)
Legal requirements in the destination country
Legal basis for medical devices in Europe
The MDR 2017/745 has been fully in force since May 2021 and replaces the previous medical device directives. It sets out comprehensive requirements for manufacturers, distributors, importers and notified bodies.
Important aspects of MDR 2017/745
- Increased requirements for clinical assessments
- Increased market surveillance and post-market surveillance (PMS)
- Stricter requirements for technical documentation
- Introduction of the European Database for Medical Devices (EUDAMED)
CE marking as a prerequisite for market entry
Manufacturers must prove that their medical device meets the general safety and performance requirements (GSPR) in accordance with the MDR. Only then may they affix the CE marking and market their product in the EU.
Information on the need for a local representative
Is a local representative required to approve or register medical devices?
Yes, it is mandatory for manufacturers outside the European Union to appoint a European Authorized Representative (EU-AR).
Requirements for the EU Authorized Representative (EU-AR)
- The EU-AR must be domiciled in an EU member state.
- It handles communication with the national authorities.
- He is responsible for checking the technical documentation.
- He is entered in the EUDAMED database as an authorized representative.
Manufacturers based in the EU do not need an authorized representative, but must ensure that their product complies with the MDR.
Definition and classification of medical devices
According to which law is this determined in Europe?
Medical devices are classified in accordance with MDR 2017/745, which classifies products according to their risk potential.
Classification of medical devices according to MDR
- Class I - Low risk (e.g. dressings, surgical instruments)
- Class IIa - Medium risk (e.g. infusion pumps, ultrasound devices)
- Class IIb - Higher risk (e.g. anesthesia machines, defibrillators)
- Class III - High risk (e.g. heart valves, stents, implants)
In addition, special classification rules apply to in vitro diagnostic medical devices (IVD) in accordance with IVDR 2017/746.
Approval procedure for medical devices in Europe
What approval procedures are there?
There are different approval procedures depending on the risk class:
- Self-declaration (for Class I products without measuring function or sterility)
- Conformity assessment by a notified body (for class Is, Im, IIa, IIb and III products)
- Clinical evaluation and market surveillance for all products
Average duration of approval procedures
- Class I: approx. 1-3 months
- Class IIa and IIb: approx. 6-12 months
- Class III: approx. 12-24 months
The duration depends heavily on the capacity of the Notified Bodies and the quality of the technical documentation.
Costs incurred
- Class I: Low costs, as no notified body is required.
- Class IIa and IIb: Between 10,000 and 50,000 euros depending on the product.
- Class III: More than 100,000 euros for approval and clinical studies.
Validity of the registration or approval
- The CE marking is generally valid for five years.
- After expiry, a new assessment must be carried out by the Notified Body.
Language requirement
- The technical documentation can be submitted in English.
- Instructions for use, labels and product information must be available in all relevant EU languages.
Conclusion
The approval of medical devices in Europe is a demanding process that places strict requirements on manufacturers. In addition to CE marking, comprehensive technical documentation and market surveillance are required.
Important points summarized:
- CE marking is mandatory for the EU market
- Strict requirements due to MDR 2017/745
- Notified bodies are required for Class II and III products
- Non-EU manufacturers require an EU authorized representative
Support from MEDAGENT
MEDAGENT offers comprehensive services for MDR approval:
- EU Authorized Representative Service (EU-AR)
- Advice on technical documentation and CE marking
- Support with conformity assessment procedures with notified bodies
For further information or assistance with the approval process, please contact us directly.
