The 5 most relevant changes the Medical Device Regulation MDR introduces, that you must know

after 25 years the European medical device directive MDD is replaced by the medical device regulation the MD are a major change for us medical device manufacturer but also as important you representative or engineering partner in this video you will learn the five most relevant changes you must know the medical device regulation is a monster one-handed 77 pages instead of 23 articles in the MVD we are now talking about 123 articles all these guys completely nuts while this explosion in size wasn't the MDD the good alte medical device directive not good enough it all started in the 1990s a Frenchman effects or filled breast implants with low quality industry silicone thousands of women were affected hundreds were forced to exploitation I was interviewed in public German TV as an expert for medical device regulations one of the questions I was asked we need you lost don't we already then my answer was no not at all we do not have a lack in regulations we have a lack of enforcement European authorities didn't actively monitor the market at least not sufficiently also not in this case it was the FDA warning first the European response came late but impressing Li and eloquently they came up with the MDR and this is what we now have to deal with the MDR replaces both the MD D and the directive for active implantable devices the aimd the IVA D is replaced by the IV d our European directives address European nations these nations must implement the directives as national laws companies and citizens must follow national laws in Congress EU regulations such as the MDR and IV dr become effective immediately without national laws okay what's not you I'd like to mention the five most relevant changes let's get started with the first change the conformity assessment procedures good news first we'll still have conformity assessment procedures and it is still the manufacturer declaring the conformity in other words Europe did not introduce an agency approving product such as the FDA or the EMA the european medicine agency only for class one products manufacturers can declare conformity without involving a notified body as in the past obviously all the numbers of the annexes were changed what has been annexed to in the MDD is now annex 9 in the MDR there is no longer an appendix product quality assurance either a notified body verifies all products or there is a quality management system for the entire product the requirements in all appendices are much more coronal and specific as they used to be in the MDD for a critical product such as active implants or products with absorbable materials special procedures have to be followed us the involvement of expert panels for certain critical products the European Commission's trust in the competency of notified body is limited the goal of a conformity assessment procedure is to prove compliance with the essential requirements now refer to as general safety and performance requirements in the past manufacturers used to harmonize standards to prove compliance now the European Commission additionally introduced the so-called common specifications these are quote a set of technical and/or clinical requirements that provides a means of complying with the legal obligations applicable to device process or system in other words manufacturers must follow both harmonized standards and common specifications are on there sufficient standards are under standard sufficient to trust in the work of center committees also seems to be limited by the way the EO foresees common specifications not only four essential requirements but also for other domains such as post market clinical follow-up technical documentation and clinical investigations second change classification the mdro still operates with the four classes 1 to a 2 B and 3 and the mdro still works with classification rules this mind map shows all the rules the color of the Flex indicates the changes green and blue stands for no or minor changes orange from major changes and red reflects near or completely rewritten rules most of the red changes are due to the fact that vmd are now also covers the active implantable products however one change addresses software as you can read this quote surfer intended to provide information which is used to take decisions with diagnosis or therapeutic purposes classified as class 2a or even higher as medical software neill in all cases serves the purpose of diagnosis and therapy otherwise it wouldn't be a medical device kind of no class one software is left a direct management system in the past last one is now class 2b or even class 3a patient data management system at least class 2b this is a disaster for all startups for all medical app and standalone software manufacturers this rule is another killer for innovation I really hope that these guys writing such rules won't need one of the medical products they prevent it by introducing the rule 11 next essential requirements respectively general safety and performance requirements these requirements are still laid down in annex 1 however the number of words in these standards doubled on top of that the new annex 2 was introduced describing requirements for the technical documentation there is a document with a detailed comparison between the old and the new annex 1 I'll give you the download link for this document at the end of this video I summarized these changes in another mind map lots of changes relate to the instruction for use and to software just for the sake of an example let's dive into the software IT security is now explicitly mentioned manufacturers have to take the specific features of different mobile platforms into account if it is a mobile application mdro demands to address screen sizes contrast ratios the physical environment as lighting and interoperability issues a development process needs to be defined and followed suffer must be verified and validated both in house and in the actual simulated environment this must include different hardware configurations if you develop compliant to IC 6 2 2 3 or 4 you already fulfil most of these requirements and this concept holds true for most of the changes the MDR introduced a lot of these requirements that have been demanded in the standards only are no part of the mdro thereby the MDR requirements are more specific and complete in comparison to those in the MDD if you aren't selling in the US market already the next change might hit you pick the unique device identification this is a unique number consisting of device identifier and product identifier the former should be unique for example for the device type or the trade name the letter IDs should be a lot or a serial number not only the products but also the packaging – beer udi labels the idea is to trace all devices to facilitate fast product recalls and thereby to enhance post market safety UDI is also supposed to help fighting counterfeit devices UDI supports tracking of products from development registration to sales logistics post market surveillance to purchase to actual usage and so forth until disposal you see this doesn't only impact the manufacturers but also the entire logistics chain the customers and authorities major new requirement think of all the IT systems that must handle UDI day term think of the changes to the labeling by the way manufacturers must persist UDA data in a european database the Udo met Udo met also collects post market date on the changes to a post market that MVR introduces are substantial the medical device directive barely addresses post market surveillance and post market clinical follow-up the medical device regulation however no has two dedicated chapters I'm talking about chap was not just articles and additionally there are two new appendices let's travel the post marked killing will follow up this is per definition a continuous process that updates the clinical evaluation the requirements with respect to clinical evaluation also became very specific and much about the matter of 2001 revision for don't unless they made the efforts to come up with the PM CF planar continuously collect and every age data and to keep not only the critical evaluation up to date even a little broader is the scope of the pre market surveillance also here our data have to be systematically and continuously being collected updated and evaluated but the outcome of these activities not just an updated clinical evaluation but any other measure such as process improvements medical device reporting product recalls and other corrective and preventive actions MDR gives pretty close guidance on planning on data sources to be considered on evolution of data and on possible measures to be taken besides these measures manufacturers must compile reports either post market surveillance report in case of +1 devices or a periodic safety update report for the other classes dependent on the class these reports must be submitted to the you damnit depending on the class also the frequency of these updates varies obviously there are many more changes introduced by the MBR than just the five ones which are briefly introduced there are new requires will respect the quality management systems there are UL such as the person responsible for regulatory compliance and intent however already the five changes will cause major workload for any medical device companies selling in the European community my tip get family with the MDR as fast as possible more than 170 pages don't sound like fun but you don't have to read them all I detected the beast in a mind map this helps you navigating the MDR easier the mind map as well as the slides are part of our starter kit download the starter kit right away from our website it's Wraith additionally I'll upload another video introducing the steps how to make rate from MVD to MDR we at the Yona Institute support hundreds of medical device manufacturers to mass of this transition as we are also working for notified bodies we exactly know what needs to be done to market your device now and in the future without hassle and unnecessary burdens if you need any help just let us know contact us your another load


  1. can I get a hard copy for this presentation

  2. Nice overview.
    What I see missing is the mapping between the Software as Medical Device and the Rule 11 of the MDR.
    If you have a product both in the European and U.S. market is now difficutl to understand e..g if you softare is class IIb or Class III.
    The unclear point is about the "death" or "irreversible" health state of the patient. This is not covered by SaMD…
    Do you have suggestions about?

  3. Thank you. We had implemented some software solutions with
    . Do you think we can expect them to do some updates to keep up with new regulations?

  4. Thanks, good overview

  5. Well described. Could you please tell me about MDCG and how they are going to help manufacturer?

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