Press Releases

Press Release New medtech regulations

Smart and efficient EU medical devices legislation needed to address future health challenges

Posted on 23.11.2011

Medtech industry outlines six steps to guarantee rapid access to safe medical technology while safeguarding innovation

Brussels, 23 November 2011 – The European medical technology industry outlines in a position paper its proposals for shaping a renewed legislative framework for medical devices in Europe.  The industry recognises the need to modernise and strengthen the current medical devices legislation in Europe and believes this should be done through coupling more enhanced Member State engagement with better European science-based coordination and management of the regulatory system. The proposed changes should lead to a smart and efficient legislative framework that is consistently implemented across the EU and guarantees high quality healthcare, patient safety and rapid access to the latest value-based medical technologies. At the same time, the suggested framework will encourage research and innovation, and reduce administrative burden, in particular for SMEs who are the backbone of the medical technology sector.

Industry calls for a legal framework that provides 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 market surveillance systems. Europe needs smart regulation that makes efficient and effective use of existing resources and involved structures (European Commission, Competent Authorities, Notified Bodies and industry) so as to retain a simple, adaptable and highly efficient system.

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.

Only the best Notified Bodies – in order to guarantee a consistent approach to the quality of the work carried out by Notified Bodies as well as a high level of safety across the EU, a complete series of control and monitoring measures are needed such as precise and mandatory requirements for the designation of Notified Bodies.

One approach to vigilance and market surveillance – to ensure a rapid and consistent EU-wide risk identification and response, there is a need for a better defined legal framework for vigilance including a centralised reporting and surveillance system based on an EU portal.

Strengthened harmonised standards – EU harmonised standards, developed jointly by regulators, industry, academia and other stakeholders, should continue to prevail as a core vehicle to ensure the safety and performance of medical devices. Processes and procedures in the revised framework for mandating and developing medical device standards must incentivise greater engagement of European authorities’ experts at international level while also encouraging pro-active and earlier involvement of Member States in the drafting of those international standards in order to overcome difficulties encountered during final implementation across the EU.

Consistent implementation of guidelines – to bring efficiencies into the EU medical device guidance development process and to tackle disparities in national implementation of those guidelines the current procedure must be urgently addressed on two fronts: Revise and improve the current procedure (e.g. actively involve and commit the Members States to uniform implementation) and upgrade the body that develops these guidelines, the European Commission’s current Medical Devices Expert Group (MDEG), from a voluntary committee to a formal Advisory Committee under the future revised legal framework.

Increased transparency – increased transparency and access to information for patients, consumers, healthcare professionals and manufacturers as well as for Notified Bodies, National Competent Authorities and the European Commission is paramount. The establishment of a single EU database, with appropriate elements available to the public, is critical and should include relevant information in vital areas such as market surveillance, vigilance and devices on the market.

An integrated approach: Better coordination and management – to strengthen the three crucial components in the regulatory framework for medical devices (coordination, science and policy advice) and to aid better and more uniform implementation across the EU, the system will require resources. These can ideally come from within the Commission from DG SANCO, supported by the Commission’s Joint Research Centre (JRC). The JRC could actively play a crucial role in key areas such as auditing Notified Bodies to ensure a comparable high level of quality across the EU, coordinating vigilance incident reporting systems, horizon scanning and foresight intelligence on potential health concerns, expert policy advice in medical technologies to support evidence-based decision making and legislation, and scientific advice on medical technologies to Member States, the European Commission and innovators.

John Brennan, Director Regulatory and Technical Affairs: “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. By improving the regulatory framework for medical devices through the six solutions outlined in our position paper, we believe Europe will become stronger in many areas. Patients will continue to have the fastest access to safe, value-based medical technologies and innovation will continue to flourish in Europe which is good for jobs and the economy. In these challenging times of constrained public budgets and ageing populations, it will be the innovative solutions in healthcare delivery that will help tackle these challenges. We suggest many improvements that aid better management of the system by authorities and the Commission. In achieving this we think that the JRC is the natural partner for DG SANCO, Member States and industry to shape and drive a smart EU medical technology legislative framework as it is independent and experienced in the broad range of technologies that reflect the medical device industry.”

For more details download the position paper: A new EU regulatory framework for medical devices