Author: Dr. Judit Balogh
The French Poly Implant Prosthese (PIP) company, a global trader in breast implants, had been manufacturing and distributing breast implants using self-manufactured and unlicensed silicone gels since 2001. Due to complaints about the implants, more specifically their ruptures, the available products were recalled in 2010, and the French government recommended medical removal of the implants to the tens of thousands women with such implants.
Among other, this scandal has facilitated the European Union to introduce reforms in the regulation of medical devices. The most significant step in these reforms is the MDR Regulation. The MDR Regulation was published by the Commission on April 5, 2017, however the application of the provisions has been phased in. The reason behind is – on the one hand – the smooth conversion from MDD Directive and – on the other hand – the significant number of new obligations that market participants have to comply with.
However, the pandemic also rewrote the above, due to the lobbying activities of MedTech Europe, the European medical device manufacturers association and several other manufacturing companies and advocacy organizations, the Commission postponed the date of full application of the MDR from May 26, 2020 to May 26, 2021. This measure provided an opportunity for medical device manufacturers to focus all their resources on combating the COVID-19.
We highlight that there has been no conceptual change in the regulation of medical devices, the Commission has not deleted any existing requirements, but the MDR Regulation – in order to improve patient safety guarantees – has supplemented new and significant number of requirements to the existing provisions.
The details illustrate that while the MDD Directive consisted 23 articles and 12 annexes, the MDR consists 123 articles and 17 annexes. Given the length of the regulation, in this information letter we only refer to some innovations introduced by the MDR Regulation, while more detailed information will be summarized in our further information letters.
In contrast to MDD, MDR regulates in detail the obligations of each economic operators.
The obligations of manufacturers are the most detailed in MDR. Among a number of other obligations, they shall comply with the general safety and performance requirements set out in Annex I of the MDR Regulation and shall assign a person responsible for regulatory compliance.
As may be inferred from the trigger reason of the legislative process, the MDR Regulation has a significant emphasis on the post-market surveillance system, which aims to establish a monitoring system for the life cycle of the device.
The obligations of distributors include the strict inspection obligation (e.g. whether there is a proper CE marking, EU declaration of conformity, whether a UDI number has been assigned), as well as the requirements for safe storage, registration and data transfer.
One of the main purpose of MDR Regulation was, inter alia, to establish a European database (EUDAMED) which, on the one hand, integrates the various databases and, on the other hand, collects, manages and publishes up-to-date information on medical devices on the market. The obligation in connection with the registration will increase as a result of keeping the EUDAMED system comprehensive database up-to-date. Not only the operators need to register in order to obtain a single registration number (SRN), but they also need to register, among other things, the products, safety and clinical performance summaries (SSCP), vigilance data, clinical trial data.
One of the main innovations of the MDR Regulation was the development of a unique device identification system, the UDI system, aimed at product traceability. Four identification numbers identify the product groups and the given products: Basic UDI-DI (BUDI), UDI-DI, UDI-PI, DI assigned at the level of the device unit of use.
These identification numbers shall be assigned to the manufacturer and placed on the packaging and documentation of the product as defined in the MDR Regulation, but there are also some obligations for distributors, such as checking the UDI number.
As a general rule, before placing devices on the market, manufacturers, authorized representatives, importers and system assemblers (collectively economic operators) are required to register in EUDAMED system.
As a result of the registration or the validation of the registration by the national authorities, these economic operators will receive an SRN (single registration number) which will identify them in subsequent procedures, such as before the competent authorities or during the certification procedure.
Registration had been voluntary since December 2020, but it is already mandatory from 26 May 2021 if the economic operator intend to place a product on the market complying with MDR Regulation or fulfil other obligations under MDR with EUDAMED.
Az eszközök rendeltetésén és kockázatukon alapuló besorolás változatlan maradt, azonban számos termék átkerült más kockázati besorolású osztályba.
The classification based on the purpose and risk of the products remained unchanged, however, many products were transferred to other risk classes.
Significant harmonization may be seen regard to softwares (MDSW), as MDR Regulation draws from so-called „level of concern” rules of U.S. Food and Drug Administration (FDA). It means that the software is to be managed independently in the scope of medical devices, its classification is based on its purpose, while according to the MDD Directive, software that controlled or influenced the use of a device automatically belonged to the product classification controlled or influenced.
The major changes in this area were introduced to MDR Regulation compared to the previous system. In a non-exhaustive way, we mentioned that implantable devices and class III devices, with a few exceptions, shall now undergo clinical trials.
In case of all class III devices and device for administer a medicinal product (or removal from the body), manufacturer shall have the opportunity to consult with group of European experts on his intended clinical development strategy and request a prior review of the strategy.
In order to ensure the stability of the medical device market and the safe supply of equipment to healthcare institutions, the application of MDR Regulation will be phased in and manufacturers will have several years to obtain certificates under MDR Regulation for their current products. This transitional period closely links to the definition of so-called legacy devices. Legacy devices mean such devices whose MDD certificates expires after May 26, 2021 or such Class I devices for the certification of which an organization already notified under the requirements of MDR must be involved. Legacy devices may be legally placed on the market until the expiry of the certificate under MDD Directive, but no later than May 26, 2024, and may be distributed until May 26 2025 (‘Sell-off provision’).
The purpose of Sell-off provision is to remove all MDD-compliant products from shelves by May 26, 2025 and devices certified under the MDD Directive shall obtain either certification under MDR Regulation or withdrawn from the market. This applies to any device that is still in the distribution system and has not reached the final user ready for use, such as a hospital.
The question correctly arises as whether legacy devices should also be registered in EUDAMED system. The answer is yes. As a general rule, these devices must be registered within 18 months from the operation of the EUDAMED device module, expected from September 2021. Within that 18-month period, a serious adverse event or field safety corrective action in respect of the legacy device shall be reported to EUDAMED and the registration thereof is required for these activities.
The question of to whom, when, how, where to register legacy devices and other medical devices under MDR Regulation is far from clear. We will summarize this issue in our next post.
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 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
 Council Directive 93/42/EEC of 14 June 1993 concerning medical devices