The 5 most important steps to CE certification - The EU medical device approval process

This video introduces the Europan medical device regulations, in particular the Medical Device Regulation MDR, the conformity assessment procedures (sometimes referred to as "certification process") and the medical device classification.
It explains when an ISO 13485 certified quality management system is required and which are the most relevant documents manufacturers have to compile
You find the checklist mentioned in the video and additional information in our starter-kit: www.johner-ins...

[@bommabhargavi3444]

Excellently explained....giving a wealth of information just in very less minutes. Look forward for more topics..

[@Harlem55]

As long as you're good with the U.S. FDA, you surpass the requirements for CE.

[@anoopbaghel7866]

Nicely explained..one thing i would request u 2 to explain that who is having final authority to classify the medical devices, if disagreements/ confusion in rule procedure and manufacturer interpretation prevails. One more thing i want u to clarify regarding class 1 devices that whether manufacturer DoC which is just a simple declaration in a paper can be considered that product is approved in EU or product is CE certified..?
Thanks in advance.

[@medizinischesoftware]

If there is a dispute the national authorities have the authority. If you don't agree with authority neither, you have to go to court.
There is no "approval" for class I devices. It is just the DoC. Class I sometimes is referred to as "self declaration". This is not quite correct, as it is always the manufacturer making this declaration. But the general notion is okay.
However, if the authority reviews your technical documentation and detects non-conformities, you are in trouble.

[@anoopbaghel7866]

@@medizinischesoftware Thanks for such prompt response. does any acknowledgement document or any certificate against such submission of DoC is being issued by any certification body or regulatory agency. And where does manufacturer submit their EC DoC. Is it through some online system or hard copy need to be submitted. Also, during such submission of DoC does detailed technical dossier of product also need to be submitted.?

[@medizinischesoftware]

@@anoopbaghel7866 You do not submit your DoC in case of class I products (yet). However, you have to register your product. This registration is online, in future via EUDAMED.
The registration may trigger the authority to ask for your documentation including the DoC. However, you would send it typically via e-mail. The registration still has to done per country. EUDAMED will change this, too. Just one registration is required, however, you have to check the countries you plan to market your device.

[@anoopbaghel7866]

Thanks for clarification.

[@orlandowan5847]

The summary presented was very useful and refers to downloadable documents. When visiting your website though I could not find the documents you mention being the comparison of MDR and MDD Essential Requirements as well as the Check List.

[@johnerinstitute4586]

I just updated our starter-kit: www.johner-institute.com/starter-kit/. It is in the subfolder /Laws/MDR/Checklists

[@mayasavaikar7804]

May you please confirm the class for Cold/cool therapy spray ?

[@JohnerInstitut]

Hello Maya, in order to make a classification we need an intended use description. You can contact us via our website www.johner-institute.com.

[@ericb6481]

Very good information thank you!

[@vikassengar9100]

May you please confirm the class for Non Sterile 3 ply Surgical Face Mask

[@medizinischesoftware]

We do offer free consultancy here: johner-institute.com/institute/ask-an-expert/. Just post your question.

[@ghulammohyuddinbhatti3292]

A very useful Lecture, we also need comparison of MDR and MDD Essential Requirements as well as the Check List as hard copy. Can we download all such requirements, so please give us track for the purpose. Thanks for guidance

[@johnerinstitute4586]

I just added a link comparing MDD and MDR requirements here: johner-institute.com/articles/regulatory-affairs/medical-device-regulation/

[@MrDamkohler]

I’m surprised of what it is said around 3:30. For devices not including sw, conformance to Annex IX (and therefore audit of the development process) is not required?

[@JohnerInstitut]

There are conformity assessment procedures that indeed rely only on testing of the individual products. This makes sense for manufacturers that only produce a very limited number of devices (instances) e.g. 50 or less.
The matter that the notified body dos not assess the quality systems does not mean that the manufacture does not need one. Every manufacturer has to establish such a system according to MDR article 10. On the other hand: What is not (externally) audited/inspected sometimes does not fulfill the requirements.

[@udaybachalakura7336]

Thank you

[@titotito8054]

COULD YOU PLEASE HELP ME TO KNOW HOW TO FIND CE CERTIFICATE FROM MIDMARK COMPANY ?

[@tanvirmahmood8738]

Sir,
How can I check it. this certificate is original & real. have any proses to justify CE certificate in online/google.

[@JohnerInstitut]

this depends on the class. for class IIa, IIb and class III check the website of the notified body that is mentioned (just number) on the certificate/ce mark. For class I products it is not really possible. and there is also no certification at all, it is only the declaration of conformity.

[@tanvirmahmood8738]

@@JohnerInstitut Sir, pliz send me your mail. i want talk to you by mail.

[@JohnerInstitut]

@@tanvirmahmood8738 [e-mail]

[@Kritzz-]

Where can I download the checklist?

[@johnerinstitute4586]

I just updated our starter-kit: www.johner-institute.com/starter-kit/. It is in the subfolder /Laws/MDR/Checklists

[@BrandHubz]

Hand Crutches fall under which class

[@JohnerInstitut]

Class I

[@tampot9007]

makhi thi panner par