EC: Kiwa Cermet Italia S.P.A. becomes 21st Notified Body

16.07.2021

News

The European Commission announced on 14 July 2021, that the Italian company Kiwa Cermet Italia S.P.A. has been appointed as the 21st Notified Body under the EU Medical Devices Regulation (MDR) 2017/745. It has been assigned the number 0476 in the EC's Nando database.

Kiwa Cermet Italia S.P.A. offers services in the field of "Testing, Inspection and Certification (TIC)".

Source:

EC: Notification

Kiwa: News

Meet the GMP Compliance Adviser

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.

The demo access is non-binding and ends automatically.

Test it now for free

You may also be Interested in the Following Articles:

What are the quality requirements for pharmaceutical gases?

22.12.2025

Question of the Week

What are the quality requirements for pharmaceutical gases?

You can view the answer here:

EMA: Update on the Guideline “Stability Testing for Variations”

19.12.2025

News

EMA: Update on the Guideline “Stability Testing for Variations”

The EMA has updated the guideline on stability testing for variations (Revision 3, applicable from 15 January 2026).

EU: Proposal for Simplification of Medical Device Rules

19.12.2025

News

EU: Proposal for Simplification of Medical Device Rules

The European Commission has proposed targeted reforms to simplify the Medical Device Regulation (Regulation (EU) 2017/745, MDR) and the In Vitro Diagnostic Regulation (Regulation (EU) 2017/746, IVDR) and to address structural implementation challenges.

19.12.2025

News

EU: Proposal for a European Biotech Act

The European Commission has presented a proposal for a European Biotech Act aimed at strengthening Europe’s biotechnology potential and accelerating the translation of innovation from the laboratory to the market.

EMA: Concept Paper for the Revision of Annex 3 on Radiopharmaceuticals

15.12.2025

News

EMA: Concept Paper for the Revision of Annex 3 on Radiopharmaceuticals

The EMA has published a concept paper outlining a future revision of Annex 3 (Manufacture of Radiopharmaceuticals) of the EU GMP Guidelines. The paper was developed in collaboration with PIC/S and adopted by the GMDP Inspectors Working Group (IWG) at its November meeting.

EMA: Q&A on QP Certification Without Physical EU Import

15.12.2025

News

EMA: Q&A on QP Certification Without Physical EU Import

The EMA has published a new Q&A addressing QP certification for batches that are neither manufactured within the EU/EEA nor intended for the EU/EEA market, and that are not physically imported into the EU/EEA.