In its essence, the MDR requests an extensive product data set including clinical data to document the whole life cycle of a medical device. Moreover, the MDR covers a broader spectrum of applications than the MDD, as it explicitly includes all products for the cleaning, sterilization, or disinfection of other medical devices ( Table 1). Better surveillance after market approval and stricter quality controls with more clinical evidence before medical device certification were requested ( 4). Both episodes forced the legislators to implement stricter rules for medical device certification. The fundamental changes in the MDR from the formerly imposed directive, the Medical Device Directive (MDD, 93/42/EEC), were triggered by the fraudulent use of technical grade silicone for breast implants, the PIP (poly implant prothèse) scandal ( 2) and adverse events related to metal hip implants ( 3). The original intention of the MDR was to “establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation”. Similarly, after Great Britain left the European Union, an adopted United Kingdom MDR was implemented with almost no deviations from the EU MDR ( 1). Switzerland has named their legislative text Medical Devices Ordinance and is referring in a vast majority of the articles to the MDR. Non-EU countries in search of EU agreements such as Switzerland and Great Britain adopted their medical device legislations as well. When entering into force, an EU regulation by definition automatically and uniformly applies to all EU countries, without a requirement to be transposed to national law. This regulation is termed EU 2017/745 or Medical Device Regulation (MDR) and opens a new chapter in the medical device rulebook. On the other hand, the MDR may also act as an antetype for similar regulations in other parts of the world, and could offer new career opportunities for individuals in dental materials research, especially in the regulatory field.Ī new regulation for the marketing and application of medical devices has become applicable in the European Union as of May 2021.
Moreover, the MDR could create a rift between dental materials scientists working at universities and the dental industry, because the latter now has to direct more money towards regulatory affairs rather than product development or innovation. The MDR could and most probably will result in a considerable reduction and price increase of the products that are available to European dentists.
This also means that smaller companies acting out of Europe are affected in a disproportionally negative manner compared to their globally acting counterparts. As is illuminated in this text, the MDR will create more red tape for industrial players to get their products CE (Conformitée Européenne) marked, and more documentation work for dentists. This article discusses the MDR from the dental perspective. The implication of this legislation has broad effects on manufacturers, importers, distributors, users of medical devices, and patients. Initially published and entered into force in 2017, it replaces the former Medical Device Directive 93/42/EEC (MDD), but is still under amendment. This regulation is termed EU 2017/745 or Medical Device Regulation (MDR). 2Conservative and Preventive Dentistry, University of Zurich, Zurich, SwitzerlandĪ new regulation for the marketing and application of medical devices has become applicable in the European Union as of May 2021.
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