European medical regulating authority, the EC, recently published a new guidance on medical device vigilance systems covering issues related to the distribution of information between national competent authorities. The document, intended to clarify definitions, set forth the form of Manufacturer’s Incident Report and describes the difference between particular information exchange systems – EU NCAR and IMDRF NCAR

Clarification of Definition

To simplify the use of applicable regulations and make them understandable for all parties involved, the guidance contains detailed definitions.

National Competent Authority Report (NCAR) – information on particular issue disseminated between National Competent Authorities (CA, national regulating authorities conducting marketing approval of medical devices, supervision, and regulation of medical device circulation on the local market).

Field Safety Corrective Action (FSCA) states for an action conducted by manufacturer to reduce risks associated with the use of a particular medical device. It covers all issues related to the devices being present at the market that could bear risk of causing serious harm to the health of patients.

Field Safety Notice (FSN), described as a special form used by medical device manufacturers to communicate with customers and users about issues related to the Field Safety Corrective Action.

According to the guidance, such actions may include the following:

  • Return of a medical device to the supplier (when manufacturers decides to revoke the devices)
  • Request for additional examination of the device by the customer
  • Modification by manufacturer
  • Request to retrofit the modification conducted by manufacturer
  • Exchange
  • Destruction
  • Providing additional advice describing the use of medical device.

General Principles

FSCA has been introduced as an additional measure for preventing harm to the health of the patients caused by devices that are already present in the market. According to the guidance, if manufacturers decide to perform any corrective actions, similar actions should be performed on all markets where such devices are already present. The same rule should be applied to safety notices – they should be provided in all countries where the device is being distributed even if there were no incidents related to the device in the particular country. It is required to provide FSN with all products of such type until the reason would no longer be valid.

The guidance also contains detailed requirements applicable to the Field Safety Notice. For example, FSN should be performed in the language accepted by the national regulating authority. It is also strictly prohibited to include any advertising materials in this type of communication. At the same time, the national regulating authority may request manufacturers to revise FSN in case of any amendments needed. 

Cooperation Between Regulating Authorities

The guidance specifies two approaches for international cooperation between national regulating authorities. According to the first one, it is necessary to determine a single coordinating authority. Such an approach could be used in case of any concerns regarding incidents, the actions performed by manufacturers, or when the broader opinion or coordination is needed. It can also be applied in the case where the manufacturer is a foreign company, so the engagement of the national regulating authority of that country would improve the process and information exchange. 

The second approach provides dissemination of information between several regulating authorities. It could be applied in the case where a manufacturer has already performed FSCA in an order set forth by applicable regulations, or when certain regulating authorities request manufacturers to perform such actions to improve them. Another reason for the dissemination of information could be if a manufacturer fails to submit a final report in time.

39 Comments

  1. Spot lets start on this write-up, I really think this amazing site needs much more consideration. I’ll more likely once more to see a great deal more, thank you that info. Nairobi xxx

    Reply
  2. You re in point of fact a just right webmaster. The website loading speed is amazing. It kind of feels that you’re doing any distinctive trick. Moreover, The contents are masterpiece. you have done a fantastic activity on this subject! how to get a service dog for anxiety

    Reply
  3. I found that site very usefull and this survey is very cirious, I ‘ ve never seen a blog that demand a survey for this actions, very curious… how to change default google account

    Reply
  4. I can set up my new idea from this post. It gives in depth information. Thanks for this valuable information for all,.. What Is Intercultural Communication

    Reply
  5. I was just browsing through the internet looking for some information and came across your blog. I am impressed by the information that you have on this blog. It shows how well you understand this subject. Bookmarked this page, will come back for more.

    Reply
  6. Great post i must say and thanks for the information. Education is definitely a sticky subject. However, is still among the leading topics of our time. I appreciate your post and look forward to more. How To Change Favicon WordPress

    Reply
  7. Your blog would increase in ranking if you post more often..”“ learn more

    Reply
  8. Hey what a brilliant post I have come across and believe me I have been searching out for this similar kind of post for past a week and hardly came across this. Thank you very much and will look for more postings from you.

    Reply
  9. Excellent and very exciting site. Love to watch. Keep Rocking.

    Reply
  10. Great post and amazing facts right here.Keep it up the wonderful work. superslot

    Reply
  11. Truly, this article is really one of the very best in the history of articles. I am a antique ’Article’ collector and I sometimes read some new articles if I find them interesting. And I found this one pretty fascinating and it should go into my collection. Very good work!

    Reply
  12. These are in fact wonderful ideas in concerning blogging. You have touched some good factors here. Any way keep up wrinting. ufabet1688

    Reply
  13. Thank you for such a well written article. It’s full of insightful information and entertaining descriptions. Your point of view is the best among many.

    Reply
  14. This was really an interesting topic and I kinda agree with what you have mentioned here!Hello, I have browsed most of your posts. This post is probably where I got the most useful information for my research. Thanks for posting, maybe we can see more on this. Are you aware of any other websites on this subjec 슬롯사이트

    Reply
  15. You can now easily login for a favorite online casino
    and click on the mobile tab. Not everybody is able to find
    a very good site as a way to make use of the cheap deals and entertainment though.
    Nowadays gaming websites provides best features and functionalities
    that assure an interactive platform.
    부산달리기

    Reply
  16. Thanks for your marvelous posting! I actually enjoyed reading it, you could be
    a great author.I will remember to bookmark your blog and will
    eventually come back from now on. I want to encourage you to continue your great
    writing, have a nice weekend!

    Website:바카라

    Reply
  17. wow your article,was amazing ,am looking forward to reading your articles more often

    Reply
  18. Positive site, where did u come up with the information on this posting?I have read a few of the articles on your website now, and I really like your style. Thanks a million and please keep up the effective work. https://mytechmore.com/how-to-delete-roblox-account/

    Reply
  19. I definitely enjoying every little bit of it. It is a great website and nice share. I want to thank you. Good job! You guys do a great blog, and have some great contents. Keep up the good work. https://livetechguide.com/what-is-runtime-broker/

    Reply
  20. Thank you again for all the knowledge you distribute,Good post. I was very interested in the article, it’s quite inspiring I should admit. I like visiting you site since I always come across interesting articles like this one.Great Job, I greatly appreciate that.Do Keep sharing! Regards, https://protechbox.com/mouse-polling-rate/

    Reply
  21. Im no expert, but I believe you just made an excellent point. You certainly fully understand what youre speaking about, and I can truly get behind that. https://www.hitechwork.com/diablo-3-pets/

    Reply
  22. We need to do better. Our country deserves people willing to have difficult conversations and solve problems together. We need to turn toward each other, not away from each other into spaces where uncomfortable discussions are treated like a crime. Without civil discourse, we risk tumbling toward civil unrest.
    카지노사이트

    Reply
  23. That Mnuchin had to put so much effort into coaxing Trump to do the right things and blocking his instinct to do terrible things aligns with all we know about the 45th president. From the beginning of his term to the end, chaos emanated from the White House. Though many hoped he might “pivot” toward normalcy, he never did stop making a mockery of his office.
    카지노사이트

    Reply
  24. While up-and-coming gender-fluid and non-binary designers like Harris Reed and Ella Boucht have begun to make their mark, it’s also no secret that the fashion establishment hasn’t made much of an effort to design for non-binary people — at least that’s if the collection after collection of drab, supposedly “gender-fluid” beige hoodies and graphic tees is to judge by.
    카지노사이트

    Reply
  25. roasting each subpar unisex capsule collection). However, in the past year or so, TikTok has becomes the grounds for a thriving style community, where non-binary content creators swap gender-affirming fashion tips or simply — but no less importantly — freely express their style. 카지노사이트

    Reply
  26. Sabatine has racked up over 948,000 followers on TikTok with an eclectic mix of videos that includes queer-focused fashion advice (as well as roleplaying a range of hyper-specific lesbian characters), For them, fashion has been an important aspect of having their gender and identity affirmed.
    카지노사이트

    Reply
  27. With 6 million views on the #nonbinaryfashion tag and 10.4 millions views on the #unisexfashion tag at the time of publish, there are numerous inspirational outfit-of-the-day posts, advice-based clips with titles like “outfits with both masc + femme energy,” and challenges like “show me your favourite non-binary outfit equation, I will start.”
    카지노사이트

    Reply
  28. transforms two old pairs of fishnets into a sheer strappy top that, as Vice narrates, makes people “think I’m wearing Mugler when I walk down the street.” For the less crafty among us, videos by the likes 카지노사이트

    Reply
  29. According to Momo Amjad, senior strategic researcher at trend forecaster The Future Laboratory, a distaste toward the fashion establishment and its norms is partly why non-binary fashion has found such a home on TikTok, especially with a capitalism-sceptic Gen Z audience.인터넷카지노

    Reply
  30. I’m truly enjoying the design and layout of your blog.
    It’s a very easy on the eyes which makes it much more pleasant for me to come here and
    visit more often. 바카라사이트

    Reply
  31. I’m truly enjoying the design and layout of your blog.
    It’s a very easy on the eyes which makes it much more pleasant for me to come here and
    visit more often. 카지노

    Reply
  32. I’m truly enjoying the design and layout of your blog.
    It’s a very easy on the eyes which makes it much more pleasant for me to come here and
    visit more often. 카지노사이트

    Reply
  33. I’m truly enjoying the design and layout of your blog.
    It’s a very easy on the eyes which makes it much more pleasant for me to come here and
    visit more often. 온라인카지노

    Reply
  34. Simply desire to say your article is as amazing. The clearness on your post is simply spectacular and that i could assume you are a professional on this subject.
    카지노사이트

    Reply

Submit a Comment

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