In September 2024, the MDCG published a revised version of MDCG 2021-4. This guidance addresses…
Classification of medical devices: Which legal provisions and guides to consider?
A key moment in the compliance process of products is their classification. It is the…
US and EU regulatory systems for medical devices in comparison
Switzerland relies significantly on imported medical devices. With the implementation of the EU Medical Devices…
Regulatory lookout: Which other new regulations may be applicable to medtech manufacturers?
The EU is preparing and implementing several new legislations that may impact medical device manufacturers…
MDR: 39th Notified Body on NANDO!
The NANDO database lists a new Notified Body under the MDR! HTCert (Health Technology Certification…
MDR: 38th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! SZUTEST Konformitätsbewertungsstelle GmbH is…
Conformity assessment: Annual report on Clinical Evaluation Consultation Procedures (CECP)
According to Article 54 of the Medical Devices Regulation (MDR), Notified Bodies have to follow…
MDR: 37th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! SLG PRÜF UND ZERTIFIZIERUNGS…
Notified Body: templates for Lists of Standard Fees
Notified Bodies assist manufacturers in the conformity assessment of certain medical devices before being placed…
MDCG Position Paper on Hybrid Audits
Implemented during the pandemic and helped by new technologies, hybrid audits have become more frequent.…