The European Parliament has adopted the European Commission’s proposal for new Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR)
The MDR and IVDR were adopted on 5 April 2017, following a final vote of the European Parliament and were published on 5 May 2017 in the Official Journal of the European Union. The new and modernised EU rules as set out in the MDR and IVDR (the Regulations) are essential to patient safety and public health in the arena of medical devices. The Regulations, which will replace the three existing Directives for medical devices and in vitro diagnostics (IVDs), will improve market surveillance and traceability, as well as providing greater transparency and legal certainty for producers, manufacturers and importers.
The European regulatory framework for medical devices has long been in need of revision to bring it up to date with technological developments and to capture products which were not previously covered by the outdated regulations (for example, previously unregulated aesthetic products, such as coloured contact lenses). The new Regulations were first proposed by the European Commission in 2012.
The Regulations are the result of many years of negotiation between the EU institutions to address gaps in legislation that resulted in numerous device-related scandals. These scandals highlighted safety concerns and the need for fundamental amendments to the regulations in this sector. The PIP scandal, relating to breast implants, intensified the requirement for a revision of the legislation, and indeed, traceability of implants and devices so that patients could effectively trace and identify whether there existed a defect within their devices.
The Regulations aim to improve the quality, reliability and safety of medical devices and introduce more stringent premarket assessment of high-risk devices such as breast and hip implants. The tighter controls will require devices to be reviewed by experts at EU level prior to being introduced to the market. Post-market surveillance will also be increased to ensure the effective identification of unexpected or unidentified problems with medical devices.
- A new device identification system will be introduced based on a unique device identifier (UDI), with more information to be made publicly available via EUDAMED (an EU-wide database on medical devices, to be established by Spring 2020).
- The rules introduce a new risk based classification system for IVDs which are in line with international guidelines for the provision of health information, such as HIV and blood testing.
- Genetic testing is also covered by the new legislation which requires medical practitioners within EU member states to advise patients of the consequences of such testing for ethical purposes.
- Controls will be tightened on clinical evaluations and clinical investigations.
- There will be stricter controls on notified bodies, which will have to employ medically skilled staff.
- The Regulations allow for random inspections of producers’ facilities after devices have been placed on the market.
- There will be an additional safety checking procedure for high risk devices, such as implants or HIV tests. In addition to a notified body, a special committee of experts, will also check that all requirements are met.
- Clinical evidence of medical device safety will need to be provided by manufacturers (as for medicines), especially in the case of higher risk classes.
- Each participant in the supply chain, including the distributor and importer, will have its own regulatory responsibilities.
- The classification rules and conformity assessment procedure for devices will be amended. The Regulations state that guidance developed for medical devices at an international level should be taken into account in applying the classification systems.
The MDR will apply following a transitional period of three years (2020), and the IVDR following a transitional period of five years (2022). The Regulations will be directly applicable in all Member States, which will help to standardise conditions for patients and industry stakeholders across the EU. This will give national regulatory bodies and medical device manufacturers sufficient time to ensure compliance with the new Regulations prior to their implementation.