Following their adoption by the European Parliament in April 2017, the final versions of the Medical Devices Regulation ("MDR") and In Vitro Diagnostic Regulation ("IVDR") were published in the Official Journal of the European Union on May 5, 2017. The Regulations will enter into force on May 25, 2017, and will become fully applicable following a transitional period of three and five years, respectively. The MDR will apply as of May 26, 2020, and the IVDR will apply as of May 26, 2022. Both Regulations make some exceptions for early application as well as additional transitional periods.
These Regulations will replace the current Medical Devices Directive (93/42/EC on medical devices), the Active Implantable Medical Devices Directive (90/385/EC on active implantable medical devices ), and the In Vitro Diagnostics Directive (98/79/EC on in vitro diagnostic ("IVD") medical devices). The new Regulations are designed to improve the quality, safety, and reliability of medical devices and in vitro diagnostics; to strengthen transparency of consumer information; and to enhance vigilance and market surveillance while supporting innovation.
Summary of the Key Changes
Below is a high-level summary of some of the key changes brought by the MDR and IVDR to the regulatory framework applicable to medical devices.
Inclusion of Products Without Medical Purpose and New Classification Rules. Certain groups of products that do not have an intended medical purpose but that present a risk profile similar to medical devices have been included in the scope of the new MDR. Examples include contact lenses; facial, dermal, or mucous membrane filling substances or articles; and liposuction equipment and laser equipment for skin treatment. For IVDs, entirely new risk-based classification rules have been introduced by the IVDR. Beginning May 26, 2022, IVD medical devices will have to be categorized in classes A to D.
New Post-Market Clinical Requirements. As of the date of application of the new Regulations, medical device manufacturers will be required to include a post-market clinical follow-up or post-market performance follow-up (for IVDs) in their post-market surveillance system in order to continuously update the clinical evaluation of the device. For implantable and class III devices, a summary of safety and clinical performance must be drawn up by manufacturers and validated by notified bodies before being made publicly available.
Stricter Rules for Notified Bodies. All notified bodies will have to be redesignated under the MDR/IVDR and comply with all requirements laid down in the respective Annex VII of the new Regulations. Notified bodies must employ medically trained staff and, among other things, must have documented procedures regarding unannounced on-site audits of manufacturers and, where applicable, of subcontractors and suppliers. The MDR and IVDR also introduce a mechanism for scrutiny of certain high-risk medical devices. Under this procedure, a manufacturer's notified body will be required to notify the competent authorities of certificates it has granted for such high-risk devices. The competent authorities and, where applicable, the European Commission may request scientific advice from expert panels in relation to the safety and performance of any device, based on its reasonable concerns.
Introduction of the Unique Device Identification ("UDI") System. The new Regulations enhance traceability requirements of medical devices throughout the supply chain by requiring that a UDI be affixed to a medical device or to its packaging. Each component that is considered a device and is commercially available on its own will be assigned a separate UDI.
Joint Responsibility of Authorized Representatives. Non-EU manufacturers of medical devices and IVDs must appoint a European Authorized Representative in the European Union. Under the new Regulations, the European Authorized Representative will be responsible for verifying that the EU Declaration of Conformity and technical documentation have been drawn up by the manufacturer and, where applicable, that an appropriate conformity assessment procedure has been conducted. Most importantly, the European Authorized Representative would be legally liable, jointly and severally, with the manufacturer, for defective devices placed on the EU market if the medical devices are not compliant with the Regulations' requirements.
Increased Transparency. The UDI, along with post-market vigilance data and ongoing clinical investigations, must be entered into the European Databank on Medical Devices ("EUDAMED"), which will become accessible to the public. The EUDAMED database is expected to be put into place by 2020.
The two Regulations include transitional provisions permitting CE Certificates of Conformity issued by notified bodies in accordance with the current Directives and prior to May 25, 2017, to remain valid until the end of the period indicated on the Certificates. Notified bodies will also be allowed to issue CE Certificates of Conformity in accordance with the current Directives after May 25, 2017. These Certificates will be issued for a period of validity not exceeding five years and will become void at the latest on May 27, 2024.
It should be noted that medical devices to which these Certificates relate may be placed on the EU market or put into service in the European Union only if, from May 26, 2020, or May 26, 2022, as the case may be, they remain in compliance with the relevant current Directives, and provided there are no significant changes in the design and intended purpose of the medical devices. Moreover, there will be related changes in some obligations related to the devices. The requirements of the MDR and IVDR relating to post-market surveillance, market surveillance, vigilance, and registration of economic operators and of devices will apply in place of the corresponding requirements in the Medical Device and In Vitro Diagnostic Directives.
Medical devices that comply with the MDR may be placed on the EU market before the MDR date of application (anticipated in May 2020) if they have been audited by a notified body designated under the MDR. Notified bodies can apply for redesignation from six months after the regulations take effect. They can test for compliance with the MDR requirements only once they have been redesignated. It has been reported that this process could take up to 18 months from the date of application for redesignation.
Therefore, in addition to monitoring the validity of their Certificates of Conformity, medical device manufacturers should ensure as soon as possible that their notified bodies will be redesignated or otherwise, initiate the process of contracting with a notified body that meets the new requirements of the new Regulations and will therefore be redesignated quickly.
In addition, the European Commission is set to adopt approximately 80 delegated and implementing acts to further specify applicable requirements and obligations under the new Regulations. Manufacturers of medical devices and in vitro diagnostics should monitor closely relevant developments.