CE marking is a legal requirement for medical devices intended for sale in Europe.
There are three European CE marking directives that specifically apply to medical devices manufacturers:
- The Medical Devices Directive (MDD) applies to all general medical devices not covered by the Active Implantable Medical Devices Directive or the In Vitro Diagnostics Directive.
- The Active Implantable Medical Devices Directive (AIMDD) applies to all active devices and related accessories intended to be permanently implanted in humans.
- The In Vitro Diagnostics Directive (IVDD) applies to all devices and kits used away from the patient to make a diagnosis of patient medical conditions.
BSI is designated as a Notified Body with a comprehensive scope under the MDD and the AIMD and can provide the full scope of services under the IVD Directive via a Notified Body partner. These services include:
- Technical documentation/file or design dossier assessment/review
- Device type examination
- Product quality assurance (based in ISO 13485)
- Production quality assurance (based in ISO 13485)
- Full quality assurance (ISO 13485)
- Batch verification/release
Nice Article I really enjoyed this post Thanks for Sharing check this out
ReplyDeleteCE Marking Certification
Thank you so much for sharing this great blog. Very inspiring and helpful too.
ReplyDeleteCE Marking Certification Egypt
Very Nice. This blog is very useful to me. Now I have clarified my doubts on CE Certification .
ReplyDeleteThis blog is entirely different from others. Thank for sharing like this post.
ReplyDeleteCE MARKING CERTIFICATION
This blog is the Best place for learning and contribution.
ReplyDeleteCE Certification Argentina
This blog helps me to get more information. Thank you sharing.
ReplyDeleteCE Certification in Qatar
Your blog very helpful, great blog i appreciate. CE Certification is a compulsory process. Before the final launch of any product, it is important to verify the quality. Moreover, to impress a customer CE certification is really vital
ReplyDeleteCE Certification
Very Nice. This blog is very useful to me. Now I have clarified my doubts. Thanks for sharing the information. CE Marking Certification
ReplyDeleteNice post. I learn something totally new and challenging on sites . It's always helpful to read content.
ReplyDeleteCE Certification
This is really a great post. Thanks for sharing. CE Marking in Bahrain
ReplyDeleteI would definitely thank the admin of this blog for sharing this information with us. Waiting for more updates from this blog admin.
ReplyDeleteCE Marking Certification
Looking for WPC License Agent, Eikonsem is India's top Regulatory, Compliance Advisory firm which provides WPC License Online Application Services in India.
ReplyDeleteCE certification in Bangladesh
ReplyDeleteIt is really very helpful for us and I have gathered some important information from this blog.
ReplyDeleteCE certification
I would definitely thank the admin of this blog for sharing this information with us. Waiting for more updates from this blog admin.
ReplyDeleteCE certification
Really it was an awesome article… very interesting to read….. CE Certification
ReplyDeleteThanks you for sharing this unique useful information content with us. Really awesome work. CE Certification in Qatar
ReplyDeleteHi, It's a nice Blog. The information you shared is very effective for everyone. So keep sharing this kind of nice Blog.
ReplyDeletece certification thailand
It is really very helpful for us and I have gathered some important information from this blog. CE Certification
ReplyDeleteI like your suggestions they are really helpful. Thank you so much for sharing this post.
ReplyDeletece certification in bangladesh
It is really very helpful for us and I have gathered some important information from this blog.. CE Certification in Dubai
ReplyDeleteBEE 5 star rated ceiling fans Bee 5 star rated ceiling fans | BEE Five-star Rated Ceiling Fans
ReplyDeleteWe now come to an electronic equipment that has dodged our interest so far. It is the quintessential ceiling fan. Researches are on regarding the power guzzling capabilities of the ceiling fan. They have been found to guzzle more power, than we actually think they do.
Management System Certification Information Security Management System is the International Standard Designed to specify the requirements for the implementation of the Security Controls in an Organization. Eikonsem provide the management system certification services please contact us.
ReplyDeletece certification. 6 Simple steps to get Ce certification in India. Eikonsem is the best consultant in Delhi NCR for any query related to certification services like bis cerification, Ce certification, bee star certification and e waste management certification and so more. our team will get in touch asap. #eikonsem #cecertification #bestcertificationserviceprovider
ReplyDeleteManagement System Certification. Management System Certification is the International Standard Designed to specify the requirements for the implementation of the Security Controls in an Organization. The AIM of ISO 27001 is a consistent and centrally controlled Management system for Protecting Information. In Addition threats to all business processes are reduced by effective monitoring and control of IT Security Risks.
ReplyDeletehello everyone, useful content. we are also provide some backlink.do please check this one. visit: CE Marking Certification
ReplyDeleteNice Post
ReplyDeletece certification cost
Thanks for sharing
ReplyDeleteCE certification