The role of creativity and innovation within the European healthcare sector is essential. The current European regulatory pathway for the implementation of these ideas into reality through the product innovation process contributes significantly to the safety, quality and efficacy of new medical devices. However all stakeholders- health companies, industry, competent authorities and notified bodies and medical device practitioners agree the European regulatory approval system needs updating.
Public consultation began on this process on the 8th May 2008 seeking the views of all the stakeholders on how the medical device directives should be updated. When the PIP implant scandal involving faulty breast implants news broke out in early 2010 this brought worldwide media attention to the current directives in place for medical device approval. The French company Poly Implant Prothese (PIP ) allegedly used cheap industrial silicone that was not intended for medical use in the breast implants. The litigation process began in 2011 in France resulting in the owner Jean Claude Mas being sent to jail for 4 years and fined 75,000 euros by a court in Marseille on the 10th Dec 2013
To further compliment the first consultation document the EU commission launched another consultation document on the 29th June 2010 on technical aspects of the directive. The way forward on the new regulatory pathway differed greatly from all the stakeholders perspectives including the political one.
On 26 September 2012, the European Commission approved a package of planned changes on innovation in health consisting of
(i) Communication on safe, effective and innovative medical devices and in vitro diagnostic medical devices for the benefit of patients, consumers and healthcare professionals
(iii) Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009
(iii) Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices
The following are the key planned changes
- Wider, clearer scope for EU legislation on medical devices – extended to include, for example, implants for aesthetic purposes, and clarified as regards genetic tests
- Stronger supervision of independent assessment bodies by national authorities
- More powers for assessment bodies to ensure thorough testing and regular checks on manufacturers, including unannounced factory inspections
- Clearer rights & responsibilities for manufacturers, importers and distributors, which would also apply to diagnostic services and internet sales
- Extended Eudamed database on medical devices – will provide comprehensive information on products available on the EU market. Non-confidential data will 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 dividing medical devices into 4 different risk categories and health & safety requirements, including labelling rules – to keep pace with technological and scientific progress
- Better coordination between national surveillance authorities, with the Commission providing scientific, technical and logistic support
- International guidelines to be incorporated into EU law.
In order for these planned proposals to come into European Union law the texts need to be approved by the European Parliament and Council. This process is currently underway.