On 12 May 2023, the Medical Device Coordination Group (MDCG) published the revised Guidance on…
Q&A on extension of the MDR transitional period and removal of the “sell off” period
Following the publication of the latest amendment to the Medical Devices Regulations (MDR and IVDR),…
Amendment to the MDR and IVDR transitional period is official!
Today, 20 March 2023, the Official Journal of the European Union published the latest amendment…
MDCG: MDR Transitional regime
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…
Legacy devices: European Commission adopts proposal to extend Transitional period & Certificates!
The European Commission has adopted a new proposal to give more time to certify medical…
New extensions to implement MDR: impact on legacy devices
The new Regulation on Medical Devices (MDR) entered into force in May 2021, replacing the…