The MDCG published on Friday a guidance document, where it further clarified Article 120 (2),…
From MDD to MDR: Transition management tool
Transition management tool (TMT) presents seven techniques for a smooth transition of economic operators to the new EU regulatory framework on medical devices — REGULATION (EU) 2017/745. Check From MDD TO MDR free preview!
Understanding transitional Period in MDR
MDR and IVDR have been published in April 2017, entered into force into 2017, and will become fully applicable respectively in spring 2021 and spring 2022. The implication of this is that a transitional period has been envisaged for MDR and IVDR manufacturers to go through to get ready to fully comply with the Regulation. This document provides guidance on how to make best use of the transitional period.
This MDR Implementation Tool was updated in May 2020 following the new Regulation amending certain provisions of the MDR.
Implementing MDR: Focus on transition period by COCIR and CAMD
Today, COCIR* issued a Position paper on the implementation of the future Regulation on Medical…
From MDD to MDR: New Transition Management Tool now on MDlaw.eu!
TMT (Transition Management Tool) is the new tool accessible on MDlaw.eu, which aims at presenting seven techniques for…
Dedicated webpages on MDR & IVDR (European Commission)
The European Commission has released dedicated webpages, which are divided in several areas, where you…
New MDR NB & UK MHRA Guidance & QMS Remote Audits
SGS FIMKO OY has joined the list of certification bodies notified under the Regulation (EU)…
MDR & IVDR: How many NBs we have?
The end of Brexit transition period (31/12/2020) has brought many important changes also for the…
Brexit & EU MDR/IVDR: Update from MHRA
The UK Competent Authority (MHRA) shared today some important insights with specific deadlines on how…
MDR/IVDR Standardisation Request
As we can read in the recently published minutes from the 19th June meeting of…