TF according to MDR 745/2017

[Woodray]

I am really confused. I am preparing a TF SOP and would like some clarification if someone can help shed the light

1. Is the TF now based on the MDR 745/2017. Is the last directive ESSENTIAL REQUIREMENTS ACCORDING TO ANNEX 1 EC DIRECTIVE 93/42/EEC still valid

2. Is there a format for declaration of conformity

3. Previously, the TF has a Part A and Part B. Do we still use this now

4. Essential requirements Check List?? Is it applicable now

I am a greenhorn, but I have to start somewhere. Would appreciate any and all advice

Thanks

 

[shimonv]

Hi Woodray,
The MDR's date of application is May 2020; until then the MDD is valid.
Furthermore, the Notified Bodies will be notified (=authorized for MDR) by end of 2018/ beginning of 2019.

Furthermore, some of the elements of MDR (i.e. EUDAMED, UDI) are not in place. I also think they should release some guidance documents to help industry understand how to implement some of the regulation.

I suggest that you keep in touch with your notified body for updates, and keep on reviewing the content of the MDR.

-Shimon

 

[Woodray]

Hi Shimon,

Thank you very much for the reply which was very informative. I now can proceed with a SOP based on MDD and can ignore MDR for the moment but I guess the CE mark will need to be renewed in May 2020 and the additional information provided then. To me this is beneficial as the need for clinical trials under the old MDD is not so stringent and the CE mark once obtained can be used for further product extensions with an easier route for the requirement of clinical trials.

Is there a fixed format for a declaration of conformity??

I know that Part One and two of the tech file is based on NB-MED/ 2.5.1/ Rec 5 Technical Documentation, General Rules, Is this right?

Thanks again and look forward to your reply

 

[shimonv]

Is there a fixed format for a declaration of conformity??

No fixed format but the minimal content is found in the 'blue guide' page 57.

I know that Part One and two of the tech file is based on NB-MED/ 2.5.1/ Rec 5 Technical Documentation, General Rules, Is this right?

Yes it is. Here is a short quote from this guidance:
"Further it will be recommended that the technical documentation is built up in a kind of a two layer system (“Summary” (so called part A in the Recommendation) and part B, the entire “Technical documentation”)"

It is reasonable to assume that the MDR will follow this two layer concept.

-Shimon

 

[Woodray]

Hi Shimon,
Thanks for the reply, its been a great help.
Cheers
Raymond

 

[Charlotte Percy]

Hi Woodray, There is an EKMED document specifying what is required in a Declaration of Conformity. EK-Med 3.9 A 4.