Medical Devices Directives

The Medical Devices Directives (MDDs) are the set of EU legislative texts which cover the European regulatory requirements for medical devices. They came into force in 1990 and regulate the standards of safety, quality and efficiency of medical devices. The Directives harmonise safety requirements and specify the measures that need to be met in order to place a device on the European market. A product which meets the relevant requirements bears a ‘CE’ mark, a legal ‘Declaration of Conformity’ to EU rules.

The MDDs have been seen as a success for European citizens, health professionals and national governments by the European Commission. The system has worked efficiently for many years and has set widely-recognised high standards for patient safety. That being said, the EU rules are now over twenty years old, and developments in medical technology and the expansion of the EU have put pressure on the current framework, as well as highlighting some shortcomings in the legal process. Therefore, the European regulatory system for market access of medical devices is currently under revision, which will affect Directives 93/42/EEC; 90/385/EEC; and 98/79/EC.

Eucomed recognises the need to modernise and strengthen the current medical devices legislation in Europe, in particular, by coupling more enhanced Member State engagement with better European science-based coordination and management of the regulatory system. The objective should be to achieve a smart and efficient legislative framework that is consistently implemented across the EU and guarantees patient safety, high quality and rapid access to the latest medical technologies. This legislative framework should at the same time encourage research and innovation and reduce administrative burden, in particular for SMEs, which are the backbone of the medical technology sector. However, the decentralised approach, which is the essence of the current system, should remain a basic principle of the future legislative framework for medical devices in order to preserve safety, flexibility and pace.

A smart and efficient legal framework for medical devices should:

1. be robust and comprehensive, and effectively protect public health, enable efficient healthcare delivery and enhance public confidence without adding unnecessary bureaucracy;
2. provide effective coordination and implementation, a proper legal basis, and greater predictability;
3. be efficient for all affected stakeholders, and provide sustainable and adaptable solutions to address future needs and challenges at national, European, and international levels;
4. be consistent, transparent and driven by science-based decision making and implementation;
5. ensure appropriate involvement of stakeholders;
6. effectively foster and support innovation.

Medical technology and services, including a large and highly skilled workforce, play a crucial role in keeping the European population healthy and productive through delivering innovation into healthcare, while also contributing to the European knowledge-based economy. The MedTech sector’s ability to continue the delivery of safe and efficient life-enhancing medical care for patients and consumers is based on its strong and immense innovative capacity, which is, in turn, dependent on the existence of an appropriate and smart EU-wide legal framework, designed to boost innovation and allow for patient access to the best quality healthcare. The ability to innovate is critical for the medical technology industry in Europe to remain competitive and continue to bring valuable contributions to efficient and high-quality healthcare delivery.

The renewed framework should provide for a consistent, EU-wide regulatory approach, through improved coordination, evaluation and certification of medical devices; consistent and comprehensive implementation across all EU Member States as well as efficient vigilance and post-market surveillance systems. We need smart regulation that makes efficient and effective use of existing resources and involved structures (European Commission, national Competent Authorities, Notified Bodies and the industry) so as to retain a simple, adaptable and highly efficient system.

In our position paper ‘A new EU regulatory framework for medical devices’, we outline our proposals for shaping a renewed legislative framework for medical devices in Europe. Six steps to a smarter legal framework for medical devices:

1. Only the best Notified Bodies
2. One approach to vigilance and market surveillance
3. Strengthened harmonised standards
4. Consistent implementation of guidelines
5. Increased transparency
6. An integrated approach: Better coordination and management