Availability and capacity of notified bodies to carry out conformity assessments for COVID-19 related medical devices and in vitro diagnostic medical devices
Posts published in “Notified Body”
Notification of a Body in the framework of a technical harmonization directive – NB 2862 -Intertek Medical Notified Body AB
Contacts to allow the check of the validity of the CE certificates
Notification of a Body in the framework of a technical harmonization directive – NB 0483 – MDC MEDICAL DEVICE CERTIFICATION GMBH
MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies
MDCG 2020-5 Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies
Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions
Team-NB Position Paper on Documentation Requirements for Drug Device Combination Products Falling in the Scope of Article 117 of MDR 2017/745.
Notification of a Body in the framework of a technical harmonization directive – CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft.
State of play of joint assessments of Notified Bodies in the medical device sector