The comments come just days after the EU published the details of its intention to revise the current regulatory frameworks for medical devices, which were last altered in the 1990s. The move comes in the wake of the PiP breast implant scandal and concerns over metal-on-metal hip replacement products.
Mike Kreuzer, executive director of technical and regulatory affairs for the trade body, the Association for British Healthcare Industries (ABHI), told BBH: “The medical device industry has long called for the overhaul of the medical device directives. We set out our position in our evidence to the science and technology committee earlier this year and we have worked with policymakers in Europe and the UK throughout the consultation process.
“Recently a number of high-profile events have shaken public confidence in the system and it is crucial that both industry and policy makers begin rebuilding this trust by improving the system and ensuring that issues such as the PiP scandal never happen again.
“The new procedure will fundamentally change the way that products are brought to market without having a positive impact on patient safety.”
The criticism mainly concerns the proposed new powers of scrutiny that will be given to regulators, enabling authorities to take a second look at individual assessments of products and to make their views known before a device is placed on the market.
The concerns are shared by the pan-European industry trade body, Eucomed. It said in a statement this week that the scrutiny procedure would ‘ultimately harm patients and negatively impact European governments and industry'.
At present devices are subjected to a conformity assessment, which for medium and high-risk items involves an independent third party, known as a Notified Body. In the wake of the PiP scandal, the spotlight fell on these organisations, with criticism that they were operating to different standards across Europe and that their decisions and actions were not being properly scrutinised.
The EU proposal states: “The existing regulatory framework has demonstrated its merits, but has also come under harsh criticism, in particular after the French health authorities found that a French manufacturer, Poly Implant Prothèse (PiP), had for several years apparently used industrial silicone instead of medical-grade silicone for the manufacture of breast implants contrary to the approval issued by the notified body, causing harm to thousands of women around the world.
The main changes proposed to the current system are:
- Wider, clearer scope extended to include, for example, implants for aesthetic purposes and clarified as regards to genetic tests
- Stronger supervision of Notified Bodies by national authorities
- More powers for assessment bodies to ensure thorough testing and regular checks on manufacturers, including unannounced factory inspections
- Clearer rights and responsibilities for manufacturers, importers and distributors, which would also apply to diagnostic services and internet sales
- An extended European database on medical devices with Eudamed providing comprehensive information on products available on the EU market. Non-confidential data will also be publicly available
- Better traceability of medical devices throughout the supply chain, enabling a swift and effective response to safety problems (e.g. recalls)
- Stricter requirements for clinical evidence to support assessments of medical devices
- Updated classification rules that devide medical devices into four different risk categories and health and safety requirements, including new labelling rules, to keep pace with technological and scientific progress
- Better co-ordination between national surveillance authorities, with the European Commission providing scientific, technical and logistic support
- Existing international guidelines to be incorporated into EU law
Commenting on the wider impact of the proposals, Kreuzer said: “ABHI welcomes many of the changes, such as stricter controls and monitoring of Notified Bodies, increased co-ordination on vigilance, and the establishment of a comprehensive registration database accessible by Governments and patients. These measures will help make the system more transparent and will improve the overall safety of patients in the UK.”
The proposals will now have to pass through the formal EU legislative procedure, with agreement needed between the European Parliament and the Council of Ministers. Once adopted, they will replace the existing directives.