22 MDR Notified Bodies on NANDO and MDCG instructions on Clinical Investigation ID · MDlaw – Information platform on European medical device regulations

The NANDO database newly lists 22 Notified Bodies under the MDR!

EUROFINS PRODUCT TESTING ITALY S.R.L. has been the latest NB notified under the Regulation (EU) 2017/745 on medical devices – MDR.

EUROFINS PRODUCT TESTING ITALY S.R.L.
Via Courgnè, 21
10156 – TORINO (TO)
Country : Italy

Phone : +39 011 2222225
Fax : +39 011 2222226

Email : tech@eurofins.com
Website : http://tech.eurofins.it

Notified Body number : 0477

You can find the full scope of its notification on the following link. Below, an extract from NANDO, where conditions are listed :

2. Active non-implantable devices for imaging, monitoring and/or diagnosis – MDA 0201 Active non-implantable imaging devices utilising ionizing radiation
- Excluded Class III Medical Devices
2. Active non-implantable devices for imaging, monitoring and/or diagnosis – MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters
- Excluded Class III Medical Devices
3. Active non-implantable therapeutic devices and general active non-implantable devices – MDA 0303 Active non-implantable devices utilising hyperthermia/hypothermia
- Excluded Class III Medical Devices
3. Active non-implantable therapeutic devices and general active non-implantable devices – MDA 0305 Active non-implantable devices for stimulation or inhibition
- Excluded Class III Medical Devices
3. Active non-implantable therapeutic devices and general active non-implantable devices – MDA 0307 Active non-implantable respiratory devices
- Excluded Class III Medical Devices
3. Active non-implantable therapeutic devices and general active non-implantable devices – MDA 0308 Active non-implantable devices for wound and skin care
- Excluded Class III Medical Devices
…

Moreover, a new MDCG document has been published! It contains instructions for generating CIV-ID for MDR Clinical Investigations via Eudamed2 as EUDAMED is not fully functional. Once operational, sponsors could obtain Single Identification Number (SIN) through EUDAMED and until then, use CIV-ID instead.

CIV-ID (Clinical Investigation ID) serves the purpose of identifying a specific clinical investigation and facilitates the communication between sponsors and Competent Authorities and among Competent Authorities.

You can find it on MDlaw Library of Documents – MDCG/CLINICAL and through this link.

Finally, Team-NB has released its Position Paper on a risk-based approach for medical devices exempted from an implant card and information to be supplied to the patient with an implanted device per Article 18.3. This document is particularly relevant for manufacturers of implants, such as sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.

The document can be found both on MDLaw Library of Documents – POSITION PAPERS and through this link.

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