Too complicated and often unclear: Since May 2021, manufacturers of medical devices have had to comply with the Medical Device Regulation (MDR).In its position paper, the VDE names problems with the MDR and makes recommendations.After the Medical Device Regulation (MDR) was postponed during the corona pandemic, the European regulation on medical devices has been in force since May 26, 2021.The MDR regulates how medical devices may be placed on the market in the European Union.These include, for example, ventilators, syringes or implants.But for more than a year, the resentment among the manufacturers has not decreased.For manufacturers in particular, the MDR is one thing above all: too complicated.As a result, hospitals are warning of bottlenecks in the supply of vital medical products.To ensure that the anger of the medical technology manufacturers does not have a threatening effect on the healthcare industry, the VDE has published a position paper: "European Ordinance on Medical Devices (MDR): Recommendations for the implementation of the requirements".Overall, the VDE experts derive 32 recommendations for action for the EU Commission but also for the responsible national authorities and sponsors of medical technologies on 17 sub-topics of the MDR implementation.The requirements for medical devices according to the new MDR have increased significantly.In addition, many of the formulations are unclear.The documentation effort has increased to such an extent that companies have to hire a significant amount of additional staff.This is a not insignificant financial effort, especially for small and medium-sized enterprises (SMEs).There are already around 100 guidelines to explain the incomprehensible and sometimes incorrect texts.There are also translation errors in the different language versions."This particularly affects young, small and medium-sized manufacturers of medical devices who only have limited resources, and it also makes it difficult for start-ups and newcomers.Therefore, in all probability, the MDR will mean that many medical devices and companies will not be able to survive on the market," said Christian Otto Erbe, Managing Director of Erbe Elektromedizin GmbH and Deputy Chairman of the German Society for Biomedical Technology in the VDE (VDE DGBMT).A big problem is the certification process.The so-called notified bodies, which must be notified according to MDR, are responsible for this, i.e. state-appointed private-sector testing organizations.The MDR has also increased the requirements here, and the notification also takes more time.As a result, the number of Notified Bodies has so far been lower than the number of Notified Bodies that were notified under the (old) Medical Devices Directives.drCord Schlötelburg, Head of VDE Health, pointed out that many manufacturers are currently having difficulty finding a notified body with free capacities: "Here it would make sense to introduce an EU service point for free capacities.In addition, there is a risk of a "bow wave" of recertification of existing products at the end of the MDR transition period on May 26, 2024, which will lead to another capacity bottleneck.The VDE recommends carrying out rolling reviews, i.e. step-by-step certification.In addition, it should be possible to make consistent use of remote audits.”In addition, the EU Commission should find a realistic way of dealing with the documentation requirements, especially in the clinical evaluation of existing products whose certification by the notified body is still valid until May 26, 2024 at the latest.An extension of the transition period would be conceivable here with regard to the delivery of clinical data as part of the post-market clinical follow-up (PMCF).An MDR-compliant certificate from a Notified Body could then be issued as part of a rolling review, subject to this evidence still to be provided.The European database for medical devices Eudamed is not yet fully operational.It plays an important role for the MDR.Eudamed is intended to serve as an information base for medical devices placed on the market and as a basis for extensive registration obligations.So far, the EU has not delivered here: out of six database modules, only three are currently (partially) available.In addition, the technical design of Eudamed is not up-to-date and only partially user-friendly.The VDE is therefore calling for the European medical device database to be fully functional as soon as possible.By clicking on "Subscribe to newsletter" I agree to the processing and use of my data in accordance with the declaration of consent (please open for details) and accept the terms of use.I can find more information in our privacy policy.It goes without saying that we handle your personal data responsibly.If we collect personal data from you, we process it in compliance with the applicable data protection regulations.You can find detailed information in our data protection declaration.I agree that 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AktG, I have to register with additional data for access to this content.In return for this free access to editorial content, my data may be used in accordance with this consent for the purposes stated here.I am aware that I can revoke this consent at any time for the future.My revocation does not affect the legality of the processing carried out on the basis of my consent up to the time of revocation.In order to declare my revocation, I can use the contact form available at https://support.vogel.de as one option.If I no longer wish to receive individual newsletters to which I have subscribed, I can also click on the unsubscribe link at the end of a newsletter.I can find more information about my right of withdrawal and how to exercise it, as well as the consequences of my withdrawal, in the data protection declaration, section Editorial newsletters.Furthermore, manufacturers of AI-based medical devices feel that they are being left behind, as in all likelihood further laws will come their way in the EU (Artificial Intelligence Act, AIA, and Artificial Intelligence Liability Act, AILA) and they will therefore not only have to do more, but also with them "double demands" are confronted.It would have to be considered here whether medical devices could be exempted from additional laws.The EU Commission must act quickly, otherwise many medical technologies "Made in Europe" will no longer come onto the market.Prof. Dr.-Ing.Jens Haueisen, Head of the Institute for Biomedical Engineering and Computer Science at the Technical University of Ilmenau and Chairman of the VDE DGBMT.That would not only be fatal for the patients, but also for Europe as a location.Spectaris criticizes MDR: few notified bodies and bureaucratic effortLink: VDE: Recommendations for the implementation of the MDR requirements (external link).Spectaris criticizes MDR: few notified bodies and bureaucratic effort10 tips: bringing medical devices to the European marketCookie Manager Reader Service Terms and Conditions Help Cancellation of Subscription Advertiser Center Media Data Privacy Policy Imprint Subscription Authors AuthorsCopyright © 2022 Vogel Communications GroupThis website is a trademark of Vogel Communications Group.You can find an overview of all products and services at www.vogel.deparentingupstream;(c) greenbutterfly - stock.adobe.com;Gerd Altman;farnell;Netflix;Nvidia;Mazda;public domain;Imec;University of Manchester;On Semi;trinamix;melexis;GE Healthcare;Rutronik;counter;Semicron Danfoss;Rebecca Miller;Lattice Semiconductor;Nadine Stegeman;Qualcomm;agsandrew;Vogel Communications Group;novel on pixabay;SI Scientific Instruments;Yokogawa;(c) Kzenon - stock.adobe.com;(c) WrightStudio - stock.adobe.com;ODVA;Luminovo;(c) Patrick Daxenbichler - stock.adobe.com;Phillips