A medical device is an instrument, device, equipment or software intended by its manufacturer to be used in humans for such purposes as diagnosis, prevention, monitoring, treatment, alleviation of disease or injury. Medical devices are heavily regulated health products. To be put on the EU market, a medical device must obtain a CE marking, which requires the conduct of a conformity procedure on the medical device in question.
In the European Union, medical devices must undergo a conformity procedure to demonstrate that they meet the legal safety and intended performance requirements. EU member states can designate accredited notified bodies to conduct conformity assessments. Depending on the type and class of the medical device, these assessments usually involve:
- an audit of the manufacturer's quality management system; and
- a review of the technical documentation prepared and provided by the manufacturer on the device's safety and performance.
The existing EU legislation regulating medical devices – the EU Medical Device Directive (93/42/EEC), the In Vitro Diagnostic Medial Devices Directive (98/79/EC) and the Active Implantable Medical Devices Directive (90/385/EEC) – will be replaced by the Medical Devices Regulation (2017/745), which:
- changes the European legal framework for medical devices;
- broadens the scope of the products and operators covered under this legislation; and
- provides for increased responsibilities and obligations for manufacturers and notified bodies.
The Medical Devices Regulation entered into force in May 2017 and will fully apply from 26 May 2020; however, its implementation over the three-year transitional period has been staggered. During this period, manufacturers can place devices on the market under the existing EU directives or the Medical Devices Regulation as long these are fully complied with.
The Medical Devices Regulation's implementation has not proceed as expected and several problems have occurred.
For example, the Medical Devices Regulation requires all notified bodies which are responsible for certifying medical device companies and their products to reregister; however, there have been significant bottlenecks in this regard. Currently, only 21 out of 59 notified bodies in the European Union have applied to be newly appointed as certified notified bodies once the MDR enters into force. Of these, five are based in the United Kingdom, whose future as an EU member state remains uncertain due to Brexit.
The European Commission estimates that no more than 12 notified bodies will be appointed by the end of 2019 (five months before the Medical Devices Regulation deadline). With tens of thousands of medical devices undergoing the certification process and notified bodies requiring three to nine months to certify a product – or possibly longer due to increased demands – capacity issues are expected.
Further, there are no guarantees that notified bodies will have enough capacity to ensure the continued authorisation of products by May 2020, particularly as numerous product categories will require certification for the first time due to the Medical Devices Regulation's new classification criteria. Moreover, the European Databank on Medical Devices (Eudamed) and important national regulations are still not in place.
Some medical device sector players consider the Medical Devices Regulation to be threat to small and medium-sized companies, which will need financial support and incentives due to high costs (eg, for acquiring sites, physicians and patients to participate in clinical trials in order to obtain the clinical data required under the Medical Devices Regulation). In particular, the development of orphan medical devices with small case numbers are seen to require governmental support programmes and special regulatory regimes to ensure high-quality patient care; otherwise, product development could be slowed and deter potential founders.
Immediate and coordinated action by EU member states, the European Commission and the European Parliament will be necessary to guarantee access to medical devices required for patient care. Further, the medical devices industry will require the European Commission to communicate openly and transparently on registering notified bodies, Eudamed's functionality and the expert panel process to enable medical device companies to prepare for the upcoming changes.
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