The Council of the European propose to amend the dates of application of certain provisions of the Medical Devices Regulation 2017/745 (MDR) superseding the Medical Devices Directive 93/42/EEC and the Active Implantable Medical Devices Regulation 90/385/EEC in accordance with the appropriate proposal submitted by the European Commission earlier on April 3, 2020, suggesting to postpone the MDR implementation.
EU Medical Device Regulatory Background
The new Medical Devices Regulation 2017/745 is intended to improve existing regulation of medical devices marketed in the EU. To ensure the possibility of its implementation, the national regulating authorities of the EU Member States already commenced the process of recognition of the Notified Bodies – specially designated entities entitled to perform conformity assessment to evaluate compliance of the medical device in question with the applicable safety and performance requirements. The devices compliant with the requirements set forth by the MDR are allowed to be marketed on the EU internal market.
It is important to mention that the actual implementation of the new regulatory frameworks faced certain difficulties leading to delays. The most important points of concerns are the following ones:
- According to the new regulations, the EUDAMED database should be established to ensure efficient information exchange among all the parties involved in operations with the medical devices. It was provided that the new database would contain the information about the notified bodies entitled to perform conformity assessment, and also about the medical devices allowed to be marketed in the EU, including the detailed information about manufacturers, authorized representatives, adverse events and field corrective and preventive actions taken by the manufacturers. Due to the numerous reasons, the implementation of the EUDAMED first was delayed and later officially postponed, providing that each module of the new information exchange system would be implemented separately.
- The new regulations provided that the conformity assessment functions should be performed by the duly recognized notified bodies in accordance with the scope of designation. It was allowed to designate notified bodies under the MDR since November 26, 2017, but at the moment there are only a few notified bodies already designated under the new regulatory framework. This situation creates ground for reasonable concerns that the lack of notified bodies designated under the MDR could lead to delays in reviews of the new applications for medical devices resulting in shortages. The number of applications to be filed by the medical device manufacturers could exceed the capacity of already designated notified bodies to review them, that could impact the availability of medical devices on the market.
EU Proposal on the MDR Implementation
The present proposal contains two key points:
- In accordance with the initial framework from the EU Council, all provisions of the Directives should be replaced with the appropriate provisions of the new Regulation until May 26, 2020. Now it is proposed to extend the initial transition period for one additional year till May 26, 2021.
- Under extraordinary conditions, certain derogations from the general conformity assessment procedures should be necessary, so it is proposed to implement the appropriate possibility to introduce such derogations on the international level in case if they are important in order to ensure public health protection.
The outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus” resulted in increasing demand on certain types of medical devices, such as ventilators, accessories thereto and other respiratory devices. At the same time, some of the vitally important medical devices compliant with the Directives could be prohibited from placing on the market before being approved and registered under the MDR, which could result in shortages in supply. To ensure the availability of the critical supply devices to the healthcare institutions, national regulating authorities introduced extraordinary measures aimed at the improvement and acceleration of regulatory procedures allowing medical device manufacturers to place their devices on the market under the simplified procedures. Certain derogations from the general registration procedures, implemented on the international (Union-wide) level could improve significantly the availability of medical devices.
EU MDR Amendments and Derogations
The document proposed by the European Council contains the list of proposed changes and amendments to the Medical Devices Regulation 2017/745, including the amended implementation dates and additional derogations. In particular, it is suggested to amend the MDR in the following way:
- The initial implementation date, indicated as May 26, 2020, should be replaced with the new data – May 26, 2021, providing one additional year of the transition period necessary for all the parties involved to ensure compliance with the requirements set forth by the new Regulation.
- Class I medical devices, compliant with the safety and performance requirements set forth by the Directives, could be placed on the market prior to the prior conformity assessment conducted by the appropriate notified body until May 26, 2024, providing that the manufacturer would maintain compliance with applicable requirements and would not make any significant changes during this period. However, the device would be subject to post-market surveillance procedures in accordance with the MDR.
- The period during which the notified bodies could be designated should be extended until May 26, 2021. At the same time, the notified bodies already designated under the MDR could perform conformity assessment and issue certificates under the new Regulation prior to the actual implementation date.
- Medical devices duly registered and placed on the market in accordance with the applicable regulation in the particular Member Stated before the new MDR implementation date could be marketed in used in the appropriate member state.
It is important to mention that the appropriate amendments to the MDR should be implemented before the initial MDR implementation date. At the same time, the European Council states that during the COVID-19 outbreak the derogations should be implemented as early as possible.
Summarizing the information provided hereabove, due to the delays in the actual implementation of the new medical device regulatory framework to be introduced by the Medical Devices Regulation 2017/745, the European Council issued a proposal to postpone the implementation of the MDR and extend the transition period for an additional year to provide all parties involved in operations with medical devices with the time necessary to ensure compliance with the new rules and requirements. At the same time, to avoid shortages and ensure the availability of vitally important medical devices during the COVID-19 outbreak, the European Council proposes to implement certain derogations introducing additional flexibilities. For example, Class I low-risk medical devices, registered under the Directives, would be allowed to be marketed and used prior to the compliance assessment under the Regulation providing that no significant changes have been made. Thus, the steps proposed by the European Council intended to ensure the uninterrupted availability of medical devices during the public health emergency in spite of legal uncertainty and delays in the implementation of the new regulatory framework.
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