Hungarian Notified Body is 12th to be Designated Under MDR

Regulatory NewsRegulatory News
| 20 March 2020 | By Zachary Brennan 

Hungary’s CE Certiso Orvos-és Kórháztechnikai Ellenőrző és Tanúsító Kft. has been designated as the 12th notified body under the EU’s incoming medical devices regulation (MDR) on Friday.

The Hungarian notified body is also designated under the EU’s medical devices directive (MDD), the active implantable devices directive and the in vitro diagnostics directive. Since the beginning of 2020, CE Certiso is just the third notified body to be designated and listed in the European Commission’s NANDO database.

Other notified bodies, meanwhile, are anticipating designations after 26 May, which is when MDR fully applies.

The European Commission has yet to offer any indication that the 26 May date will be pushed back due to the coronavirus, although the association Team-NB has indicated that travel restrictions have hampered MDR implementation efforts and affected ongoing surveillance and unannounced audits necessary for conformity assessment to the existing directives.

According to the European Commission’s latest update on joint assessments of notified bodies in the medical device sector, 40 on-site assessments have been completed under MDR and three more notified bodies may be soon added to the NANDO database.

And notified bodies may currently be focused on certificates issued under the MDD before the MDR fully applies that may remain valid for up to four additional years.

NANDO MDR Database


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