PCBC - Notified Body in the scope of the MDR Regulation

We are happy to announce that the long-awaited official confirmation of PCBC S.A.’s competences to implement processes according to the new guidelines of the MDR Regulation has become a fact.

As the second notified body in Poland, we obtained notification in the field of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amendment of Directive 2001/83 / EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385 / EEC and 93/42 / EEC.

Official entry in the NANDO database available at [link]

This is the success of the entire PCBC S.A. Team and especially the employees of the Medical Device Certification Department, who have shown great commitment and knowledge at the highest level. We sincerely thank them for this and we would like to invite our clients to cooperate in the field of certification of medical devices.

Photo: PCBC archive

We sincerely thank them for this and we would like to invite our clients to cooperate in the field of certification of medical devices.