Replacing the MDD by May 2020
The EU Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in the EU and compliance with the regulation is mandatory for medical device manufacturers that want to sell their products in Europe. The MDR replaces the MDD (medical device directives) regulations that manufacturers currently must adhere to. The MDD is being replaced by the MDR to address such factors as advances in software, patient-controlled apps, and a need for greater transparency for the general public. The new MDR will encourage wider compliance with standardized medical device regulations throughout Europe. The United Kingdom, as part or not part of the EU, will also initially follow the MDR.
The regulation was published on May 5, 2017, and comes into force on May 25, 2020. Currently approved medical devices will have a transition time of three years. (until May 26, 2020) to meet the new MDR requirements, after which all devices, new or existing, must comply with the MDRs. For devices already having CE marking, this means that when their CE marking meets its expiration date they must be resubmitted under the new MDRs during the 3-year transition. By May 26, 2020, only medical devices conforming to the new MDRs will be allowed for market in Europe. There will be no grandfathering.
The European Union treats compliance regulations very differently from the United States. The CE mark indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). This makes the CE marking recognizable worldwide even to people who are not familiar with the European Economic Area.
The Medical Devices Regulation is a complex piece of legislation. Compared to the MDD (Medical Devices Directive), the MDR promotes a shift from the pre-approval stage (i.e., the path to CE Marking) to a life-cycle approach. This approach is similar to the life-cycle view advocated by the US Food and Drug Administration (FDA) and advanced by many international standards.
Some significant changes are that
•The MDR places greater emphasis on clinical data and clinical evaluations. Equivalence, currently commonly used to justify references to studies done with other devices, will be more rigorously interpreted. Manufacturers will need to generate and provide more in-depth clinical data to prove safety and performance claims.
•The MDR includes a mandate for Unique Device Identification (UDI) that is intended to facilitate the traceability of all medical devices sold in the region. Devices must be marked with a device identifier (DI) and each batch or production series of the product will be marked with a production identifier (PI).
•The MDR introduces new databases for clinical investigations, product registration, and post-market surveillance. The EUDAMED database will function as part of a system of several databases that allows Notified Bodies, medical device companies, consumers, regulators, and other stakeholders to access the latest data on medical devices for sale in Europe.
•Manufacturers will need to report all incidents, injuries and deaths into an EU portal that will centralize relevant data so that patients have access to more safety-related information. Reporting for incidents that did not result in death or serious deterioration in health is moved to 15 days from 30 days.
•Reclassification of many medical devices to a higher risk class and a new classification for reusable surgical devices requiring notified body oversight.
Regarding the manufacturer’s quality management system, manufacturers shall establish, document and implement a quality system, and maintain its effectiveness throughout the entire device lifecycle. Companies undergoing transition will need to revisit core processes including the quality assurance, risk management, and postmarket expectations. These will require careful review, planning and updating to re-implement in compliance with new requirements.
Medical device companies can still receive compliance certification from Notified Bodies up to the effective date of May 26, 2020, and these certificates will remain valid for five years from the date of issuance, allowing for a smooth transition period. Devices that are legally placed on the market before the effective date can be sold until five years after the MDR takes effect, but their compliance certificates will all become void on 25th May 2024.
The EU MDR joins the ISO 13485:2016 and the MDSAP program driving greater standardization and stronger post-market surveillance requirements, along with process-oriented risk management and a life-cycle approach to device management.