All medical device manufacturers should be aware that the last CE certificate renewal deadline expires later this month. Those who miss it could face regulatory issues, delays, and additional expenses.

CE Certificate Renewal Requirements

According to the Medical Device Regulation (MDR 2017/745 EU), all medical device manufacturers should renew the CE safety conformity certificate for their products obtained under the Medical Device Directive (93/42/EC) that had been replaced by the MDR. The Regulation enters into effect in May 2020, so manufacturers have to renew certificates for existing products prior to that date. In accordance with the new rules set forth by the MDR, appropriate submissions should be filed to Notified Bodies – special entities designated by national regulating authorities to perform functions in the sphere of medical device circulation. Notified Bodies are responsible for reviewing new medical device applications. The issue is that there are only a few entities designated at the moment which creates grounds for reasonable concerns that they will not be able to handle the substantial number of submissions filed by medical device manufacturers within a short period of time. This situation could probably lead to delays in medical device supply that could be harmful for healthcare institutions and patients using such devices. This is the primary reason as to why medical device manufacturers strongly recommend to accelerate the renewal process to be able to market their products within the European Union. 

 

 

Terms and Timelines

As for now, medical device manufacturers have two options, depending on the expiration date of the certificates. They are:

  • To renew the existing certificate in accordance with the MDD
  • To file for the certificate issued under the MDR.

The second approach is preferable since it simplifies further procedures. Notified Bodies already have the responsibility of reviewing submissions under the MDR. The reclassification process required under the new regulations should be completed as soon as possible. After this, medical device manufacturers would have to notify authorized bodies on any important changes to the medical device, its functions, and purpose. The whole renewal process could take four months or even more since Notified Bodies are likely to be overloaded with submissions. Some of these Notified Bodies already ceased to accept submissions for Class IIa, Class IIb and Class III medical devices while the acceptance of submissions for Class I (Sterile or Measuring devices) would be suspended at the end of August, so medical device manufacturers have very limited time to file an application for the CE certificate renewal. The acceptance suspension dates set by different Notified Bodies may vary, but in general they are almost the same. 

 

 

About RegDesk™

RegDesk’s platform provides medical device manufacturers with important updates and changes to regulations in a reliable and timely manner. Compliance with Medical Device Regulations is important for any manufacturer that plans to distribute its products in the EU market. 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.

42 Comments

  1. Normally I don’t learn post on blogs, but I wish
    to say that this write-up very forced me to try and do it!
    Your writing style has been surprised me. Thanks, very nice article.

    Reply
  2. Nice write up. Nice write up. I enjoyed reading what you had to say. Good job on this article!

    Reply
  3. Thanks so much for the post. Cool.

    Reply
  4. I have been looking everywhere for this! You appear to know a lot about this. You’ve made my day! Thx again. I enjoyed reading what you had to say.

    Reply
  5. Hey, thanks for the blog article.Really looking forward to read more. Fantastic.

    Reply
  6. Thank you ever so for you blog.

    Reply
  7. Im grateful for the blog post.Thanks Again. Really Great.

    Reply
  8. Im obliged for the blog article.Really looking forward to read more. Want more.

    Reply
  9. Awesome article.Much thanks again. Really Great.

    Reply
  10. 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
  11. Enjoyed every bit of your article.Really looking forward to read more. Really Great.

    Reply
  12. Do you ever get burnt out from writing all these great articles? Great post! You are a very persuasive writer. You appear to know a lot about this.

    Reply
  13. Thank you for your article post.Thanks Again. Keep writing.

    Reply
  14. Major thanks for the blog article. Cool.

    Reply
  15. Thanks-a-mundo for the blog.Much thanks again. Really Cool.

    Reply
  16. I just want to tell you that I am very new to blogging and site-building and seriously enjoyed you’re blog. Almost certainly I’m going to bookmark your blog . You actually have incredible stories. Thanks for revealing your web-site.

    Reply
  17. I think this is a real great article.Thanks Again. Want more.

    Reply
  18. Good job on this article! Great post! my hobbies include and .

    Reply
  19. I really liked your post.Thanks Again. Fantastic.

    Reply
  20. I simply want to tell you that I am new to blogging and actually liked your web site. Probably I’m want to bookmark your website . You certainly have great stories. Bless you for sharing with us your web site.

    Reply
  21. I truly appreciate this blog.Thanks Again. Really Cool.

    Reply
  22. I enjoyed reading this. like and . It’s like you read my thoughts!

    Reply
  23. Thanks-a-mundo for the article.Thanks Again. Want more.

    Reply
  24. Cheap Gucci Handbags Is usually blogengine much better than wp for reasons unknown? Should be which is turning out to be popluar today.

    Reply
  25. An impressive share, I just given this onto an associate that was doing a little evaluation on this. As well as he as a matter of fact purchased me breakfast since I discovered it for him. smile. So let me rephrase that: Thnx for the treat! Yet yeah Thnkx for investing the time to discuss this, I feel highly concerning it and also love finding out more on this topic. Preferably, as you end up being expertise, would you mind upgrading your blog with more details? It is extremely useful for me. Large thumb up for this post!

    Reply
  26. Precisely that is close to my heart… Many thanks! Exactly where are your contact details though?

    Reply
  27. Wow, great article post.Really looking forward to read more. Really Great.

    Reply
  28. This information is magnificent. I have been looking everywhere for this! This is an excellent, an eye-opener for sure! Not everyone is great at being both creative and still being organized.

    Reply
  29. An intriguing discussion might be priced at comment. I do believe you should write much more about this topic, it will not be considered a taboo subject but usually people are there are not enough to talk on such topics. To the next. Cheers

    Reply
  30. Hey! I’m at work browsing your blog from my new iphone! Just wanted to say I love reading through your blog and look forward to all your posts! Carry on the excellent work!

    Reply
  31. You bring up a lot of great facts there. You are obviously very knowledgeable. Nice write up. I enjoyed reading what you had to say.

    Reply
  32. Thanks for ones marvelous posting! I genuinely enjoyed reading it, you could be a great author.I will always bookmark your blog and will often come back someday. I want to encourage you to definitely continue your great work, have a nice afternoon!

    Reply
  33. You made some suitable points there. I viewed on the web for the concern and also found most individuals will certainly go along with with your internet site.

    Reply

Submit a Comment

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