New EU medical device and IVD regulations have entered into force By MHRA Published: 15 December 2017 On 25 May 2017, new EU regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR) entered into force, marking the start of a three- and five-year transition period. During the transition period, new devices can be placed on the market under the current EU Directives, or the new Regulations (if they fully comply with the new Regulations). However, devices placed on the market after the transition period will need to fully comply with the MDR, unless they wish to make use of the extended period of CE certificate validity (see MHRA’s guidance page for more information on placing a device on the market under the new Regulations). The new Regulations have introduced a number of key changes Changes to risk classifications and increased scope The introduction of new risk classification rules means that certain devices will be reclassified into high risk categories, and thus will require a more stringent assessment. For example, certain devices, currently classified as Class I (low risk) devices under the Medical Device Directives, will be classified as Class IIa devices under the MDR. This means that these manufacturers would now need to undergo a conformity assessment procedure with a notified body. This also applies to IVDs, with the majority of IVDs being up-classified under the new legislation. The definition of a medical device has also been updated to include certain groups of products without an intended medical purpose, listed under Annex XVI of the MDR (for example, non-corrective contact lenses, dermal fillers, and brain stimulation devices). Changes to clinical investigations and performance studies The new Regulations introduce increased requirements for clinical evidence, particularly for higher risk and implantable devices, over the product lifecycle. One of the key changes is that there will be much stricter rules around how manufacturers can use clinical data from equivalent devices on the market. Post-market, manufacturers will be expected to follow their device more closely, continuing to generate evidence through post-market clinical follow-up. There has been a significant alignment with the new Clinical Trials Regulations for clinical investigations. For example, the new Regulations introduce the requirement for damage compensation, clarifies the role of a ‘Sponsor’, promotes the single assessment of clinical investigations across multiple Member States, and includes specific provisions on informed consent. There will also be a requirement for manufacturers to conduct performance studies with in vitro diagnostic devices in order to provide “sufficient clinical evidence”. To bring IVDs more in line with medical devices, applications for performance studies will need to be submitted to competent authorities. Increased traceability of devices and incidents The existing European database (Eudamed) will be undergoing an overhaul. There will be a greater emphasis on traceability throughout the whole supply chain through the introduction of a unique device identification (UDI) system, which manufacturers must fit on their devices, enabling greater control over safety alerts, potential recalls and surveillance tasks. The Eudamed database will also be expanded to capture more complex data on devices. This includes information regarding economic operators, notified bodies, certificates, clinical investigations, vigilance and market surveillance. It will also enable more accurate trend reporting analyses. Much of this information will be made available to the public These new requirements, combined with obligations for sharing of data between competent authorities, should make the new Eudamed far more useful. However, these changes, particularly the assignment of UDI, will incur significant costs, and can be expected to take several years to embed fully. If the Commission has not readied the new Eudamed in time, then these provisions will also be postponed accordingly. Clearer obligations for those involved in manufacturing and supplying devices Manufacturers and authorised representatives will now be required to employ at least one person who will need to fulfil a number of responsibilities to ensure regulatory compliance. The new Regulations also set out more rigorous vigilance reporting requirements, including new reporting timescales, as well as clearer requirements on what a manufacturer’s post-market surveillance (PMS) system should comprise of. How can medical research charities prepare? There are a number of additional changes that the new Regulations introduce to those mentioned above, so we recommend medical research charities should familiarise themselves with these and begin to implement a transition plan for meeting the new requirements. The MHRA have produced an Introductory Guide to the MDR and IVDR, which will help you understand the changes in the new regulations. If you have any queries on the new Regulations, you can contact the MHRA at: [email protected].