On April 5, 2017, the EU adopted the Medical Device Regulation, replacing the two existing directives, the Medical Devices Directive and the Active Implantable Medical Devices Directive.
The purpose of the new MDR is to increase safety and efficiency in the EU medical device market. The predecessors of the MDR; the Active Implantable Medical Devices Directive (AIMDD) and the Medical Devices Directive (MDD), which were introduced in the early nineties, served their purpose for a long time and helped create the market for medical devices in Europe.
This note provides an insight into key requirement of MDR.
Product scope expansion – The MDR applies to an expanded range of medical devices including products that were not previously covered by the MDD and AIMDD. Specific examples of newly covered medical devices include those that do have not a medical intended purpose, such as colored contact lenses and cosmetic implant devices and materials. Also included in the scope of the MDR are devices designed for the purpose of “prediction and prognosis” of a disease or other health condition.
Identification of “person responsible for regulatory compliance” – Device manufacturers are now required to identify at least one person within their organization who is ultimately responsible for all aspects of compliance with the requirements of the MDR. The organization must document the specific qualifications of this individual relative to the required tasks. Special relief for some of these provisions may be applicable to small enterprises and start-up entities.
Reclassification of devices according to risk, contact duration and invasiveness – Annex VIII of the MDR details the requirements governing the classification of medical devices. In several instances, the MDR classification requirements are more rigorous than those in the MDD or AIMDD, resulting in the assignment of a higher risk class for some devices and the need to meet more stringent requirements than in the past.
More rigorous clinical evidence for class III and implantable medical devices – Device manufacturers are now required to conduct clinical investigations to support claims of both safety and performance in a medical device in cases where sufficient clinical evidence is not available. Manufacturers are also required to collect and retain post-market clinical data as part of the ongoing assessment of potential safety risks.
Systematic clinical evaluation of Class IIa and Class IIb medical devices – Manufacturers should carefully consider the MDR’s strict requirements on the use of evidence of equivalence in determining whether or not a clinical investigation is required.
Implementation of unique device identification –The MDR mandates the use of unique device identification (UDI) mechanisms with medical devices. This requirement is intended to support the ability of manufacturers and Authorities to trace specific devices through the supply chain, and to facilitate the prompt and efficient recall of medical devices that have been found to present a safety risk. In addition, the European Databank on Medical Devices (EUDAMED) has been expanded to provide more efficient access to information on approved medical devices.
Common Specifications for Single-Use Devices – The EU Commission has published a set of “Common Specifications” applicable to the reprocessing of medical devices intended solely for single use. Published in August 2020 in the Official Journal of the European Union, Commission Implementing Regulation (EU) 2020/1207 presents a detailed set of procedures and steps to be followed by device manufacturers in the reprocessing single-use devices for reuse, quality management system requirements, and traceability provisions.
Rigorous post-market oversight – The MDR mandates increased post-market surveillance (PMS) authority by the Notified Body. Unannounced audits, along with product sample checks and product testing will strengthen the EU’s enforcement regime and help to reduce risks from unsafe devices. Annual safety and performance reporting by device manufacturers is also required in many cases.
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