Becoming increasingly important also for the med tech sector in view of the technical advancement,…
Public consultations: reprocessing of single-use MD and cybersecurity
Public consultations have opened for the below two documents: → Commission Implementing Regulation concerning reprocessing…
Implant Card under the MDR {MDCG}
The MDCG released on 1st of July 2019 a Guidance on the Implant Card (IC)…
MDCG releases guidance on Person Responsible for Regulatory Compliance
On July 1st 2019, a MDCG guidance has been published to better clarify the role…
Draft EMA Guideline + MDCG Guidance to be endorsed
EMA (European Medicines Agency) has opened public consultations on the draft Guideline for drug-device combination…
UDI issuing entities: first names revealed
The European Commission was mandated and released a draft Commission implementation Decision together with the…
MDCG Q&A for Notified Bodies
The MDCG has just published useful Questions & Answers document, especially relevant for the Notified…
MDCG on registration of devices in EUDAMED (timelines)
In the most recently endorsed document, the MDCG addressed the issue of inconsistency between Article…
MDCG on registration of ”legacy” devices
The second document related to EUDAMED was published today on the European Commission website. The…
New MDlaw Checklist: Crucial tool to show compliance with Annex I MDR
New GSPR Checklist, now available in our MDlaw e-shop was carefully prepared by our experts…