On October the 5th, 2015, the EU Council of Ministers agreed on its baselines on the looming two Regulations on medical devices and in-vitro medical devices. Closely related to the Commission’s relevant proposal and the adjacent EU Parliament and EU Council reports, both Regulations will aim to modernize the existing legislation, taking into account the latest advancements in medical technology and the need for high protection of patient safety.
Main forthcoming changes are summarized as follows:
- The new rules will take the form of a Regulation, which, by replacing the existing Directions, will presumably contribute to the harmonization of the legal regime and its uniform application in all the European countries.
- The scope of the Regulation will be extended, including non-viable human tissues (e.g. syringes prefilled with human collagen) and invasive products for cosmetic purposes (non- corrective contact lenses, implants) as well as diagnostic probes and cameras.
- The new regime imposes key obligations on manufacturers, regarding the performance of the clinical evaluation needed to demonstrate the safety and performance of their devices. The proposals by the European Commission suggest that demonstration of compliance with the general safety and performance requirements should be based on clinical data that, for class III medical devices and implantable medical devices should, as a general rule, be sourced from clinical investigations. Τhese will be completed under the responsibility of a sponsor, who can be the manufacturer or another legal or natural person authorized to carry out the investigation. Additionally, an electronic publicly accessible database on clinical investigations is planned to work interoperable with future databases of clinical trials on medicinal products. This database is intended to serve as a tool for the cooperation between Member States. Specifically, sponsors, when conducting investigations in more than one countries, will submit a single application, thereby reducing administrative burdens. It should be underlined that the Commission has taken the right of personal data protection into high consideration. For this reason, no personal data of subjects participating in a clinical investigation should be recorded in the electronic system.
Furthermore, in order to ensure the compliance to safety standards, it is proposed that the instrument of common technical specification used for IVDD shall be introduced in the field of MDD.
- Another important measure of the new legislation concerns the parallel trade of medical devices already in the market. According to EU law and the decisions of the European Court of Justice, this is a lawful form of trade within the internal market with some conditions imposed. Therefore, the European institutions agreed that the requirements for relabeling and repackaging medical devices should be strictly specified. According to the EC proposal, prior to making the relabeled or repackaged device available, the distributor or importer shall inform the manufacturer and the competent authority of the Member State where he plans to make the device available and, upon request, shall provide them with a sample or a mock-up of the relabeled or repackaged device, including any translated label and instructions for use. Additionally, he shall submit to the competent authority a certificate, issued by the notified body.
- Moreover, an issue which has caused heated debate among the interested parties concerns the reprocessing of single-use devices. The proposal contains strict rules on the reprocessing, in order to ensure a high protection level of health and safety. According to the Commission, reprocessing of single-use devices is considered as manufacture of new devices, resulting in the reprocessor’s need to comply with the obligations incumbent upon manufacturers.
- Furthermore, a Unique Device Identification (UDI) system is going to be implemented, which, together with the further development of EUDAMED (European databank on medical devices), involving the registration of devices, manufacturers, importers and distributors and of all the elements concerning a product (certificates, clinical investigations, vigilance and market surveillance) aim to combat lack of transparency and enhance the traceability of the devices.
- The new regime is intended to reinforce the notified bodies’ accreditation and supervision and enhance the quality control processed by these bodies with new measures, namely by restricting the outsourcing of auditing work, by authorizing a Qualified Person within the organization (similar role to that defined in pharmacovigilance legislation). The empowerment of Notified Bodies is going to be achieved by providing them with the right to undertake unannounced controls at the premises of medical device industries.
- Finally, a scrutiny mechanism is created; it concerns the obligation of Notified Bodies to address an expert committee about new applications for conformity assessment of high-risk devices. According to the European Commission, this scrutiny mechanism empowers the authorities to have a ‘second look’ at individual assessments and make their views heard before a device is placed at the market.
The Commission’s Proposal foresees that the Regulation on medical devices will be applicable three years after its entry into force, while the Regulation on IVD will apply after 5 years. The Parliament has therefore supported a three-year transition period for IVDs, too.
Our law firm’s comment:
The European legislator is called upon to introduce a new regulatory framework, which will adapt to the rapid development of medical technology and satisfy the needs of citizens for better safety regulations in all EU member states. Striking the right balance between innovation and safety, competitiveness and control, has always been a challenge; more so within a fast development pace of technological change.
Not all cards are yet on the table; there are still remaining issues over which the representatives of European industries of medical devices and in-vitro medical diagnostics (EUCOMED and EDMA respectively) have expressed opposing views and supporting arguments, particularly regarding:
- the upwards reclassification of medical devices implying new modes of assessment,
- the “scrutiny mechanism”,
- the rules on reprocessing single use medical devices,
- the risks for intellectual rights violations due to information disclosure on devices and manufacturers,
- the device labeling requirements about hazardous substances (carcinogenic, mutagenic, toxic etc.).
We consider that the European legislator should avoid measures which impose unnecessary and disproportionate bureaucratic burdens and expenses on the industry as well as on –already strained – national public health systems. It is of vital importance that stakeholders and scientists, based on both vision and experience, maintain communication with the European institutions in order to defeat any temptations of suspicion and to strengthen transparency for the long-term interests of the EU citizens.