CE marking for Medical devices as per Medical Device Regulation (MDR 2017/745)

[K.P.M.]

Hello ,

We are looking for consulting firm or person who can guide & get "CE mark" approval for our equipment as per
"Medical Device Regulation (MDR 2017/745)"

Please give lead.

Regards,
Kejul

 

[The Obturator]

You may want to see the information contained in this link. One of your requirements will be finding an acceptable Notified Body in your country.

https://leonresearch.com/medical-devices-europe-mdr-2017-745/

and/or

https://eumdr.com/

Or go to the EU pages from here;-

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745

Per ISO-4126, only the term Safety Valve is used regardless of application or design.