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

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

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.

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.

@@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.?

@@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.

Thanks for clarification.

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

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

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

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.

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.

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

@@tanvirmahmood8738 mail@johner-institute.com

Class I