The European Commission’s formal proposals for the revision of the Medical Devices Directives 90/385/EEC and 93/42/EEC (MDD) have today been submitted to the Council and European Parliament (click here to view). Also published are parallel, separate proposals for a revision of the IVD Directive 98/79/EC (not addressed in this alert).
The current medical devices legislation in Europe is over twenty years old. Developments in medical technology and the expansion of the EU have made modernisation and strengthening of the regulatory framework appropriate in particular following the recent PIP breast implant cases. The stated objective of the Commission’s proposals is to create a legislative framework that is consistently implemented across the EU and guarantees patient safety, high quality and rapid access to the latest medical technologies. The framework is also intended to encourage research and innovation, and reduce administrative burdens for SMEs in particular. The decentralised approach adopted in the current regulatory system will be maintained under the revised regime.
The following are likely to be of interest to industry:
- An EU Medical Devices Regulation (MDR) has been proposed with the aim of promoting uniformity of practice across the member states (MSs). However, the twin objective of achieving free circulation within the single market is maintained. Enforcement will still be via national MS laws.
- The Commission will be granted significant implementing powers within the new MDR, in consequence of which interpretative issues, previously dealt with via guidance (MEDDEVs) will likely have force of law in future.
- The MDR will cover both active implantable medical devices (AIMDs) as well as general medical devices (MDs) - but not IVDs.
- The Commission’s response to the European Parliament’s call for a pre-market authorisation for high risk devices has been addressed via a pre-market scrutiny mechanism. This entitles the (to be) formally constituted Medical Devices Coordination Group (MDEG) to require sight and prior review of a Notified Body’s preliminary conformity assessment of new Class III devices, and potentially other categories of devices too. This power of scrutiny is to be exercised on the basis of specified, scientifically valid health reasons and according to specified criteria, such as novelty of the technology.
- The supply chain will be directly regulated, especially at the point of first entry into the EU. This constitutes a marked change from the MDD regime. Industry should therefore carefully review the way its own supply chain is structured and check that relevant contract provisions are put in place to accommodate the new requirements. Much of this supply chain regulation is predictably linked to the significantly increased registration requirements which will be managed centrally by the Commission via the Eudamed database and which are directed at improving traceability and market surveillance of MDs, amongst other matters.
- Some clarification is provided as to when the obligations of a manufacturer transfer to others in the supply chain, e.g. where there has been product modification following first placing on the market. Reprocessing of single use devices (SUDs) is also regulated, as is in-house manufacturing by health institutions.
- The role of the manufacturer’s European authorised representative (AR) is also regulated in more detail. Again manufacturers and ARs should review their contractual arrangements in light of the proposals.
- Both manufacturers and ARs will have to have at least one Qualified Person who must have expert knowledge of medical devices / medical device regulatory requirements. This follows a trend seen in pharmaceutical legislation of designating named individuals with personal responsibility for compliance. The actual scope of responsibility is, however, unhelpfully vague.
- Increased transparency requirements, e.g. manufacturers will have to provide summaries of safety and clinical performance for all Class III and implantable devices. These will be made available publicly via the Eudamed registration process.
- The scope provisions have been clarified (e.g. non-viable human tissue products which are not ATMPs and invasive cosmetic products are now both within the scope of the MDR).
- There are new essential requirements for standalone software, of which entities who are active in the e-health field should take note. The additional regulatory power to introduce the common technical specification has also been introduced for MDs and AIMDs.
- The clinical investigation requirements have been adjusted to accommodate the concept of “sponsor” and to allow some degree of centralised application processing for multi-centre clinical investigations.
The proposals are now open for consideration by both the Council and the European Parliament via the co-decision procedure. The timing of the adoption of the proposals will depend on if and how quickly agreement is reached over any potential amendments to the text, but could potentially be as early as 2014. The new MDR will likely become applicable three years after it enters into force.