Danish Medicines Agency (DKMA) announced that they would provide special consultation on the requirements set forth by Medical Device Regulation (MDR 745/2017). These consultations are intended for small and medium size medical device manufacturers who face issues with regulatory compliance.

DKMA on Regulatory Requirements

According to the information on the pilot project initiated by the DKMA, the authority would provide detailed guidance and consultation to medical device manufacturers looking for additional information on compliance assessment and important issues such as submission filing. The new pilot project is a response to the increasing demand after the EU MDR created new rules increasing the level of safety and customer protection. The implementation of new requirements set forth by MDR could potentially cause delays in the supply of medical devices due to regulatory issues and legal uncertainty. The main goal of the project is to provide information necessary to small and medium entities representing the substantial market share. These companies could face regulatory issues after the implementation of new rules requiring them to:

  • Appoint a special person responsible for regulatory compliance
  • Implement the Unique Device Identification system
  • Comply with new certification requirements
  • Submit a new medical device application to Notified Bodies who are designated to perform application examination, market approval, and post-market maintenance. 


Terms of Consultation

Consultations would be provided in the form of one-on-one meetings with the DKMA representatives. They would discuss various issues related to application requirements, clinical trials, examination procedures, and on certification requirements (including the CE safety certification necessary to market products within the European Union). The guidance provided in the consultations would not cover issues related to the market approval of medical devices. All startups and companies interested in consultation would have to book and schedule a meeting in advance. The consultations would start from August 15th and will be held until the end of the year. DKMA stated that the timeline could be extended if they found it necessary.

There are only a few months left before the new requirements set forth by EU MDR become binding, so the medical device manufacturers will have to accelerate all compliance procedures to be able to market their devices. At the same time, there are only a few entities designated as Notified Bodies, so it is possible that some delays may occur. That is why it is important for the parties involved to clarify all legal aspects in advance to avoid delays in supply. 

RegDesk’s platform provides medical device manufacturers with a wide range of information covering important regulations related to approval, manufacturing, marketing, importation, and labelling of medical devices applicable to various national and regional markets. It is important for manufacturers to maintain compliance with the appropriate regulations to be able to deliver their devices to the customers.


  1. Today, I went to the beachfront with my children.
    I found a sea shell and gave it to my 4 year old daughter and said “You can hear the ocean if you put this to your ear.” She placed the shell to her ear and screamed.
    There was a hermit crab inside and it pinched her ear.
    She never wants to go back! LoL I know this is completely off topic but
    I had to tell someone!

  2. I just want to mention I am just beginner to blogging and site-building and certainly enjoyed your web page. Most likely I’m likely to bookmark your blog . You absolutely have outstanding writings. With thanks for sharing your web site.

  3. Oh my goodness! a tremendous article dude. Thank you Nonetheless I’m experiencing difficulty with ur rss . Don know why Unable to subscribe to it. Is there anybody getting equivalent rss problem? Anybody who is aware of kindly respond. Thnkx

  4. It?s difficult to discover well-informed people on this topic, yet you sound like you recognize what you?re speaking about! Many thanks

  5. My spouse and i were really delighted Emmanuel managed to finish up his investigations because of the precious recommendations he gained from your own web site. It is now and again perplexing to simply find yourself giving freely steps that some other people may have been selling. And we also realize we now have you to give thanks to for that. These explanations you have made, the straightforward web site menu, the relationships you assist to engender – it is mostly wonderful, and it is leading our son in addition to us do think this issue is exciting, which is certainly especially fundamental. Many thanks for the whole lot!

  6. Hi, I think your site might be having browser compatibility issues. When I look at your blog site in Ie, it looks fine but when opening in Internet Explorer, it has some overlapping. I just wanted to give you a quick heads up! Other then that, great blog!

  7. I’m not that much of a online reader to be honest but your blogs really nice, keep it up! I’ll go ahead and bookmark your website to come back later on. Many thanks

  8. I?d need to get in touch with you here. Which is not something I typically do! I delight in checking out a message that will certainly make individuals assume. Likewise, many thanks for enabling me to comment!

  9. I?d need to contact you here. Which is not something I generally do! I take pleasure in reviewing an article that will certainly make individuals assume. Additionally, thanks for permitting me to comment!

  10. There are very a great deal of details this way to take into consideration. That is a excellent denote bring up. I provde the thoughts above as general inspiration but clearly you will find questions such as the one you talk about the location where the most important thing will likely be in honest excellent faith. I don?t know if guidelines have emerged about items like that, but Almost certainly that a job is clearly defined as a good game. Both kids feel the impact of only a moment’s pleasure, for the remainder of their lives.

  11. An impressive share, I just given this onto a coworker who was doing a little analysis on this. And also he in fact purchased me breakfast due to the fact that I located it for him. smile. So let me rephrase that: Thnx for the treat! Yet yeah Thnkx for spending the moment to discuss this, I really feel highly about it and love finding out more on this subject. Preferably, as you end up being knowledge, would you mind updating your blog site with even more information? It is very handy for me. Big thumb up for this post!

  12. You made some respectable points there. I looked on the net for the problem and also found most people will certainly support with your web site.

  13. You made some respectable points there. I viewed on the internet for the problem and also found most people will go along with with your web site.

  14. It’s an amazing article designed for all the online people; they will get advantage from it
    I am sure.


Submit a Comment

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