Brussels, 9 January 2012 – The European medical technology industry association Eucomed notes with great concern recent press reports that the French firm Poly Implant Prothèse (PIP) may have violated the regulations by using unapproved industrial-grade silicone in some of its implantable products and by allegedly falsifying or withholding documents. If these or other allegations are confirmed, Eucomed strongly condemns PIP’s behaviour and breach of trust. Patient safety, public confidence, and ethical behaviour should always be the top priorities of any organisation active in the healthcare industry.
Launched in 1990, the current European regulatory system for medical devices has proven to ensure a high level of safety and quality of medical devices, while making innovative medical technology available faster than elsewhere in the world. Unfortunately, however, no system can entirely guard against fraud or deliberate abuse. Eucomed supports effective measures that prevent a similar case happening in the future. The European regulations for medical devices are currently under revision and Eucomed has submitted proposals that would strengthen and modernise the current system (please see the appendix for more details).
Breast implants for medical purposes are regulated in Europe as ‘Class III’ medical devices. As such, they attract the strictest pre-market controls by independent assessment bodies. Those bodies (called Notified Bodies) are appointed and overseen according to pan-European requirements by national authorities, which are also responsible for post-marketing surveillance. The controls include pre-market review of the manufacturer's design and safety data for the product (called a design dossier), which includes material safety and compatibility and clinical evaluation based on clinical data.
The manufacturer’s facilities, records, and quality management system are also subject to regular audits by the responsible Notified Body, typically every 6-18 months. The manufacturer is legally obliged to ensure that any changes to the approved design, specifications, materials, or manufacturing processes are supported by documented evidence to prove continued compliance with the safety and performance requirements. Planned changes are reported to the Notified Body for further review.
Whilst continuing to support the main elements of the current regulatory model, which have proven to be highly effective, Eucomed recognises the need to modernise and strengthen the current medical devices legislation in Europe. It believes this should be done by coupling enhanced Member State engagement with better science-based coordination and management of the regulatory system at European level. 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.
Eucomed is on record as calling 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 and merit public confidence.
Six steps to a smarter legal framework for medical devices:
- Only the best Notified Bodies;
- One approach to vigilance and market surveillance;
- Strengthened harmonised standards;
- Consistent implementation of guidelines;
- Increased transparency;
- An integrated approach: better coordination and management.
For more details download Eucomed’s position paper: A new EU regulatory framework for medical devices.
APPENDIX – Summary of the Eucomed Position Paper - A new EU regulatory framework for medical devices
Six steps guaranteeing rapid access to safe medical technology while safeguarding innovation
1. 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 and monitoring of the work of Notified Bodies.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
Download Eucomed’s position paper: A new EU regulatory framework for medical devices