In October 2022, Team-NB published several position papers. The first position paper concerns the technical documentation to provide to Notified Bodies, whereas a second one…
NB Position Papers on Cybersecurity and “Off-Label” Use
Team-NB recently published various position papers. Two of the latest publications concern Cybersecurity and “Off-Label” use of medical devices under MDR. Team-NB is the European…
NB Position Papers on Class D devices in absence of EURLs and time to implement guidance documents
Between September and October 2022, Team-NB published various position papers. One of them addresses class D devices and their conformity assessment in absence of EU…
NB Position Paper: What are Hybrid Audits and how to perform them?
In September 2022, Team-NB published a position paper on hybrid audits for quality management system assessments of medical devices under MDR/IVDR. Team-NB is the European…
MDR: 33 Notified Bodies on NANDO
The NANDO database newly listed 33 Notified Bodies under the MDR! POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.ul. Puławska 469 02-844 WarszawaCountry : Poland Phone :…
Swissdamed: Database for Medical Devices in Switzerland
In Switzerland, Swissmedic enforces the registration of economic operators and medical devices. For this purpose, Swissmedic introduced a new database: Swissdamed. Swissdamed stands for “Swiss…
MDR & IVDR: Manual on borderline classification issued!
In September 2022, the Medical Devices Coordination Group (MDCG) issued a manual addressing borderline and classification under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic…
MDCG position paper on Notified Body capacity and availability of medical devices and IVDs!
The Medical Device Coordination Group (MDCG) released a new position paper on the transition to the Medical Devices Regulation (MDR) and In Vitro Devices Regulation (IVDR) this…
Reclassification of products without an intended medical purpose: European Commission publishes a draft act
The new draft act available on the website of the European Commission aims at regulating active products without an intended medical purpose falling under Annex…
Notified Body Designation process: MDCG guidance
The Medical Devices Coordination Group (MDCG) has released this August a guidance on the designation, re-assessment and notification under MDR & IVDR of conformity assessment…