The adoption of Medical Device Regulation is a new step towards the improvement of the medical device regulatory framework. Regulation 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (or the MDR) replaces the Medical Device Directive 93/42/EEC.

In general, new regulations set forth additional requirements applicable to medical devices. Since the Regulation aims to increase safety and protect public health, it introduces several important changes including the following:

  • Increasing role of Notified Bodies – special entities designated by national regulating authorities to review market applications, conformity assessments, and examine medical products. Notified Bodies are also responsible for post-market surveillance.
  • Additional rules of risk-based classification for several types of medical devices.
  • Additional requirements on pre-market trials and examination to ensure the safety of the products.

The Medical Device Regulation also implemented two entirely new elements:

  • Unique Device Identification (UDI). Each medical device distributed within the EU market would have a special number allowing for individuals to find more details about the device such as its purpose, associated risk, the device manufacturer and its authorized representative. All information would be stored in a special database which would simplify access.
  • Person responsible for compliance. Medical device manufacturers shall designate one particular specialist as the person responsible for regulatory compliance. This person would maintain communications with regulating authorities. To be able to carry on such functions, designated person should have proper qualifications and professional experience.

These new regulations expanded the scope of applications substantially – now it include devices that are not intended for medical purposes, along with different prognosis devices.

The MDR became effective on May 25, 2017. There is a special transitional period that will last for three years until May 26, 2020, that provides medical device manufacturers with enough time to comply with new regulations.

Blank space

Blank space

About RegDesk™

RegDesk Platform intends to provide medical device manufacturers with all necessary information on regulatory issues in an accurate and timely manner. Regulatory requirements incur substantial changes in the market, and to be aware of new amendments and improvements while maintaining compliance with all applicable regulations is extremely pertinent.

Blank space

Blank space

136 Comments

  1. I read this piece of writing completely on the topic of the difference of
    latest and earlier technologies, it’s remarkable article.

    Reply
  2. We came across a cool web-site that you might enjoy. Take a look when you want.

    Reply
  3. Please pay a visit to the web-sites we stick to, like this 1, because it represents our picks through the web.

    Reply
  4. There is clearly a lot to know about this. I consider you made various good points in features also.

    Reply
  5. Wow, wonderful blog layout! How long have you been blogging for? you make blogging look easy. The overall look of your site is great, as well as the content!

    Reply
  6. pretty useful material, overall I think this is worthy of a bookmark, thanks

    Reply
  7. You made some decent factors there. I regarded on the internet for the difficulty and located most individuals will associate with together with your website.

    Reply
  8. What i do not realize is if truth be told
    how you’re now not actually a lot more neatly-appreciated than you may be right now.
    You are very intelligent. You realize thus
    significantly on the subject of this matter, made me in my
    opinion consider it from a lot of numerous angles. Its like women and men aren’t fascinated unless it is something
    to do with Lady gaga! Your personal stuffs excellent.
    Always maintain it up!

    Reply
  9. It as hard to find experienced people in this particular subject, but you sound like you know what you are talking about! Thanks

    Reply
  10. Thanks for writing this. Great read. Nice read. Good job on this article!

    Reply
  11. Some nice points there. Interesting content. I enjoyed your post. Thank you. I enjoyed your post. Thank you.

    Reply
  12. Thanks for sharing, this is a fantastic blog.Really looking forward to read more. Will read on…

    Reply
  13. Thanks-a-mundo for the article.Really looking forward to read more. Fantastic.

    Reply
  14. the time to read or visit the material or internet sites we have linked to beneath the

    Reply
  15. I really liked your post.Thanks Again.

    Reply
  16. Greetings! Very useful advice within this post! It is the little changes that make the most important changes. Thanks for sharing!

    Reply
  17. below you will uncover the link to some internet sites that we consider you must visit

    Reply
  18. Really appreciate you sharing this article.Really looking forward to read more. Great.

    Reply
  19. Types Of Hybridisation Biology Sci Tech Moygashel

    Feel free to visit my web page :: ebook

    Reply
  20. Dialect In Film And Literature Reese Witherspoon Book
    Club Picks 2019

    Also visit my site – best books

    Reply
  21. I really liked your post. Fantastic.

    Reply
  22. we came across a cool internet site that you simply might take pleasure in. Take a search if you want

    Reply
  23. below youll discover the link to some web sites that we feel you need to visit

    Reply
  24. Fantastic blog post. Really Great.

    Reply
  25. Your style is unique in comparison to other people I have read stuff from. Thank you for posting when you have the opportunity, Guess I’ll just book mark this site.

    Reply
  26. Support the man born of prophecies Cuong Truong a.k.a. King of kings and Lord of lords 777 immortality smart contracts space coffins in space funeral homes.

    Reply
  27. I cannot thank you enough for the blog post.Really looking forward to read more. Really Great.

    Reply
  28. Great, thanks for sharing this blog article.Really thank you!

    Reply
  29. we like to honor numerous other net web-sites around the web, even though they arent linked to us, by linking to them. Beneath are some webpages worth checking out

    Reply
  30. although sites we backlink to beneath are considerably not associated to ours, we really feel they’re essentially really worth a go by, so have a look

    Reply
  31. Pride And Prejudice Volume 1 Summary Science Quotes

    Also visit my site … library

    Reply
  32. the time to study or check out the content material or web-sites we have linked to beneath the

    Reply
  33. always a huge fan of linking to bloggers that I love but really don’t get lots of link really like from

    Reply
  34. the time to study or pay a visit to the content material or web-sites we have linked to below the

    Reply
  35. Bbc Bitesize Ks3 Lord Of The Flies Neverwhere Mr Croup

    Feel free to visit my web blog – pdf

    Reply
  36. Good job on this article! I have almost no doubt that it’s extremely difficult to apply this stuff in the real world. Some nice points there. It’s like you wrote the book on it or something.

    Reply
  37. Appreciate you sharing, great post. Keep writing.

    Reply
  38. I am so grateful for your blog post.Much thanks again. Cool.

    Reply
  39. I really enjoy the post.Really thank you! Will read on…

    Reply
  40. Spot on with this write-up, I actually think this web site needs much more attention. I’ll probably be back again to read through more, thanks for the advice!

    Reply
  41. I simply want to tell you that I’m beginner to weblog and honestly savored this web page. More than likely I’m want to bookmark your site . You really come with exceptional well written articles. Thanks for sharing with us your web site.

    Reply
  42. here are some links to web-sites that we link to because we assume they’re really worth visiting

    Reply
  43. The details talked about within the write-up are a few of the best accessible

    Reply
  44. Leading Online Pharmacy – Contact us at +1 (917) 259-3352 for unbelievable rates, discount and offers on any medicine. Get it delivered free of cost at your door steps, call us today. Phone : +1 (917) 259-3352

    Reply
  45. although internet sites we backlink to below are considerably not associated to ours, we really feel they’re essentially worth a go by, so have a look

    Reply
  46. Really appreciate you sharing this blog.Thanks Again. Really Cool.

    Reply
  47. Just beneath, are numerous completely not associated web pages to ours, nevertheless, they’re certainly worth going over.

    Reply
  48. A Court Of Thorns And Roses Series Free Download Literature Reading Reacting Writing Pdf

    Feel free to surf to my page; book epub

    Reply
  49. Thumbs up! I enjoyed reading this. Nice write up. I enjoyed reading this.

    Reply
  50. Department Of Higher Education Missouri Popular
    Books Have Been Written By

    Also visit my blog: book epub

    Reply
  51. although web-sites we backlink to beneath are considerably not connected to ours, we feel they are basically really worth a go by, so possess a look

    Reply
  52. Here is a good Weblog You might Come across Fascinating that we Encourage You

    Reply
  53. one of our guests recently proposed the following website

    Reply
  54. one of our visitors not too long ago proposed the following website

    Reply
  55. Wonderful story, reckoned we could combine some unrelated information, nonetheless truly worth taking a search, whoa did one particular master about Mid East has got additional problerms at the same time

    Reply
  56. we like to honor lots of other internet sites around the net, even if they arent linked to us, by linking to them. Beneath are some webpages really worth checking out

    Reply
  57. Say, you got a nice blog.Much thanks again. Really Great.

    Reply
  58. I just want to say I’m newbie to blogs and definitely loved this blog site. Likely I’m going to bookmark your website . You certainly come with remarkable articles and reviews. Thanks a bunch for sharing with us your website page.

    Reply
  59. always a massive fan of linking to bloggers that I adore but do not get a great deal of link really like from

    Reply
  60. Below youll obtain the link to some web pages that we think you must visit.

    Reply
  61. The Doors Of Stone Kiedy Premiera Jesus Calling
    Leather Book

    my web-site :: ebook

    Reply
  62. Usually posts some incredibly fascinating stuff like this. If youre new to this site.

    Reply
  63. Everything is very open with a really clear clarification of the challenges. It was truly informative. Your site is very helpful. Many thanks for sharing!

    Reply
  64. I really enjoy the blog. Want more.

    Reply
  65. Pseb 12th Result Gurdaspur Nature Physics Jobs

    Visit my site :: library

    Reply
  66. An outstanding share, I simply given this onto an associate who was doing a little analysis on this. And he actually purchased me morning meal since I found it for him. smile. So let me reword that: Thnx for the treat! Yet yeah Thnkx for investing the time to review this, I really feel highly concerning it and also love learning more on this subject. When possible, as you come to be competence, would you mind updating your blog site with even more details? It is very useful for me. Big thumb up for this article!

    Reply
  67. School Of Education Regent University Frost Science Museum Miami Fl

    Feel free to visit my web page – book epub

    Reply
  68. Always a big fan of linking to bloggers that I adore but do not get a good deal of link appreciate from.

    Reply
  69. The facts mentioned within the article are several of the best readily available

    Reply
  70. hi!,I like your writing so much! share we keep up a correspondence extra approximately your post on AOL? I require a specialist on this space to solve my problem. May be that is you! Looking ahead to peer you.

    Reply
  71. Here are a few of the websites we recommend for our visitors

    Reply
  72. The information and facts mentioned inside the article are a few of the best obtainable

    Reply
  73. Very good information. Lucky me I discovered your website by accident (stumbleupon). I’ve book-marked it for later!

    Reply
  74. The facts talked about within the write-up are several of the very best offered.

    Reply
  75. Awesome blog.Much thanks again. Fantastic.

    Reply
  76. Usually posts some very intriguing stuff like this. If youre new to this site.

    Reply
  77. Leading Digital Marketing agency in India and Kolkata, Leading Web Design company. Providing web designing and Digital marketing services, Digital marketing course, and certification with an internship.

    Reply
  78. Well I really enjoyed reading it. This tip provided by you is very constructive for accurate planning.

    Reply
  79. Can I simply say what an alleviation to discover someone who actually understands what theyre talking about on the net. You certainly know just how to bring a problem to light and also make it essential. Even more individuals require to read this and also understand this side of the tale. I angle believe youre not a lot more preferred because you certainly have the present.

    Reply
  80. Hey! I could have sworn I’ve been to this website before but after reading through some of the post I realized it’s new to me. Anyways, I’m definitely delighted I found it and I’ll be bookmarking and checking back frequently!

    Reply
  81. I cannot thank you enough for the article post.Much thanks again. Will read on…

    Reply
  82. It’s hard to find knowledgeable people in this particular subject, but you sound like you know what you’re talking about! Thanks

    Reply
  83. A fascinating discussion is worth comment. I do believe that you ought to publish more on this subject, it might not be a taboo matter but typically folks don’t discuss these issues. To the next! Kind regards!!

    Reply
  84. Really enjoyed this blog.Really thank you! Cool.

    Reply
  85. Wonderful story, reckoned we could combine a couple of unrelated information, nevertheless truly really worth taking a look, whoa did one particular understand about Mid East has got much more problerms as well.

    Reply
  86. I bet anything you spit knowledge. I enjoyed reading this. It’s like you read my thoughts! Great read.

    Reply
  87. usually posts some very interesting stuff like this. If youre new to this site

    Reply
  88. Aw, this was an incredibly good post. Spending some time and actual effort to produce a top notch article… but what can I say… I put things off a whole lot and don’t seem to get nearly anything done.

    Reply
  89. Here are some hyperlinks to web-sites that we link to mainly because we feel they are worth visiting.

    Reply
  90. I really like and appreciate your article post. Keep writing.

    Reply
  91. Sites of interest we’ve a link to.

    Reply
  92. the time to study or visit the content material or internet sites we have linked to beneath the

    Reply
  93. Greetings, I believe your website may be having internet browser compatibility problems. When I take a look at your website in Safari, it looks fine but when opening in IE, it has some overlapping issues. I simply wanted to provide you with a quick heads up! Apart from that, excellent website!

    Reply
  94. always a significant fan of linking to bloggers that I really like but do not get lots of link adore from

    Reply
  95. Sites of interest we’ve a link to

    Reply
  96. This information is magnificent. I truly appreciate this post. You appear to know a lot about this. Great post!

    Reply
  97. I like the valuable info you provide in your articles. I will bookmark your weblog and check again here frequently. I’m quite certain I’ll learn many new stuff right here! Good luck for the next!

    Reply
  98. This website is really a walk-through for all of the details you desired about this and also didn?t know that to ask. Look right here, and you?ll certainly discover it.

    Reply
  99. You are a very persuasive writer. Thanks for writing this. Nice read. I enjoyed reading what you had to say.

    Reply
  100. I’m the owner of JustCBD Store company (justcbdstore.com) and am aiming to develop my wholesale side of company. I really hope that someone at targetdomain can help me ! I considered that the most effective way to do this would be to talk to vape companies and cbd retail stores. I was hoping if anyone could suggest a dependable site where I can get Vape Shop Business Leads I am already reviewing creativebeartech.com, theeliquidboutique.co.uk and wowitloveithaveit.com. Unsure which one would be the most suitable solution and would appreciate any guidance on this. Or would it be simpler for me to scrape my own leads? Ideas?

    Reply
  101. Having read this I believed it was rather informative. I appreciate you finding the time and energy to put this informative article together. I once again find myself spending a lot of time both reading and commenting. But so what, it was still worthwhile!

    Reply
  102. The next time I review a blog, I really hope that it does not disappoint me as long as this set. I suggest, I know it was my selection to check out, yet I really assumed youd have something intriguing to say. All I hear is a number of yawping regarding something that you can take care of if you werent too active trying to find attention.

    Reply
  103. It’s like you wrote the book on it or something. You are a very persuasive writer. {Your article has proven useful to me. |You’ve really changed my way of thinking about things on more than a few things today.|I enjoyed reading what you had to say.|I enjoyed your post. Thank you.|I’ve been saying exactly the same thing for years. Some nice points there.

    Reply
  104. An intriguing conversation deserves remark. I believe that you ought to create extra on this subject, it may not be a forbidden subject yet typically people are not enough to speak on such topics. To the following. Thanks

    Reply
  105. Hi there! I could have sworn I’ve been to this site before but after browsing through many of the articles I realized it’s new to me. Regardless, I’m certainly delighted I stumbled upon it and I’ll be bookmarking it and checking back often!

    Reply

Submit a Comment

Your email address will not be published. Required fields are marked *