On 5 April 2017, four and a half years after the European Commission first proposed measures to replace the existing directives governing medical devices and in vitro medical devices, the European Parliament formally adopted the Medical Device Regulations and In Vitro Diagnostics Regulations (the "Regulations"). The Regulations aim to enhance patient safety and modernise public health by introducing an enhanced governance framework around the definition, supervision, traceability and risk based classification system for medical device equipment.
Some key elements of the new legislation include:
- Expansion of definition of medical devices: The breadth of medical devices has been significantly expanded and includes certain products which previously did not fall under the definition of a medical device, for example, eye contact lens solution, liposuction equipment and laser equipment used for hair and tattoo removal.
- Enhanced vigilance and market surveillance: Once devices are available for use on the market, manufacturers will be obliged to collect data about their performance and EU countries will coordinate more closely in the field of market surveillance.For traceability purposes, most medical devices will have to have unique identifiers with these details being recorded in an EU database.
- Tighter controls: The new rules will impose tighter pre-market controls on high-risk devices and apply a more stringent approach to the conduct of both clinical evaluation and the clinical investigation of clinical trials. EU cross-border clinical trials will be subject to a single coordinated assessment. Stricter requirements on the use of hazardous substances are also introduced. The legislation will also demand a more in depth review on the bodies that can approve the marketing of medical devices. Notably authorised bodies will provide more frequent, unannounced and in depth manufacturing site inspections.
- Introduction of a risk based classification system: A new system for risk classification in line with international guidelines will apply to in vitro diagnostic medical devices in addition to a wider medical device classifications definition for all products. The legislation will also require EU member states to inform patients of the consequences of DNA tests taking into consideration ethical requirements.
- PMSS: As part of their quality management system, manufacturers must also establish a "post-market surveillance system" (PMSS), which should be proportionate to the risk class and the type of device in question. Medical device manufacturers will be required to designate at least one person with responsibility for regulatory compliance who possesses the requisite expertise in the field of medical devices.
- Strengthening transparency of information for consumers: The new regulations will ensure vital information is easy to find. For instance, patients will receive an implant card with all the essential information, and a unique device identifier will be mandatory for every product so that it can be found in EUDAMED - the new European database of medical devices.
- Financial compensation measures must be in place: The Regulations require manufacturers to have measures in place to provide sufficient financial coverage in respect of their potential liability. Such financial coverage shall be proportionate to the risk class, type of device and the size of the enterprise.
Following their publication in the Official Journal of the EU (OJ), the new Regulations will have a staggered transitional period, with some aspects becoming legally binding after 6 months. However, all legislation in relation to medical device products will be entered into force three years (2020) after the publication in the OJ, and after five years for In Vitro diagnostic medical devices (2022).