Following the clarifications from the MDCG, our MDR dedicated e-books were updated to reflect the recent updates and prepare you adequately for the requirements of…
First Guideline on cybersecurity of medical devices incorporating software (MDIS)
Becoming increasingly important also for the med tech sector in view of the technical advancement, cybersecurity aims at incorporating measures, both technical and organisational, that…
Public consultations: reprocessing of single-use MD and cybersecurity
Public consultations have opened for the below two documents: → Commission Implementing Regulation concerning reprocessing of single-use medical devices (rules and common specifications) until 20th…
Implant Card under the MDR {MDCG}
The MDCG released on 1st of July 2019 a Guidance on the Implant Card (IC) disciplined by MDR Article 18 and on information to be…
MDCG releases guidance on Person Responsible for Regulatory Compliance
On July 1st 2019, a MDCG guidance has been published to better clarify the role of PRRC. The main clarifications focused on qualification of the…
Draft EMA Guideline + MDCG Guidance to be endorsed
EMA (European Medicines Agency) has opened public consultations on the draft Guideline for drug-device combination products that will close on the 31st of August 2019.…
UDI issuing entities: first names revealed
The European Commission was mandated and released a draft Commission implementation Decision together with the Annex listing the following four issuing entities designated to operate…
MDCG Q&A for Notified Bodies
The MDCG has just published useful Questions & Answers document, especially relevant for the Notified Bodies. It focuses on the Notified Bodies’ requirements under MDR…
New expert group under MDR
A new expert subgroup of the MDCG was established to cover Annex XVI products; therefore issues with products without an intended medical purpose but falling…
Clinical Evaluation Report: New MDR implementation tool
The results of clinical evaluation and clinical evidence on which it is based shall be documented in a clinical evaluation report (CER), which shall support…