MDR application may be halted for 1 year. European Commission announces proposal to help the fight against COVID-19.
Today’s live read-out by the European Commission spokesperson Stefan De Keersmaecker announced a proposal to delay the application of the new MDR. “The European Commission is working on a proposal to postpone the entry into force of the new Medical Devices Regulation for 1 year. We are working hard to submit this proposal early April and we call on Parliament and on Council to adopt it quickly as the deadline for entry into force is at the end of May. This will relieve pressure from national authorities and industry and it will allow them to focus fully on urgent priorities related to the coronavirus crisis”.
Earlier this week, Medtech Europe has issued a press release calling for a pause on IVDR and MDR implementation to facilitate the fight against COVID-19 and to safeguard Healthcare Systems. “The industry is working relentlessly to provide personal protective equipment (PPEs), diagnostics, respiratory devices and other critical medical equipment to patients, healthcare workers, and hospitals on the COVID-19 frontline.”
The date of application of the MDR was set to be 25 May 2020.
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Table of Contents
Build a Defensible Clinical Evidence Strategy Under EU MDR
Build a defensible clinical evidence strategy under MDR Annex XIV, from the clinical evaluation plan to PMCF and notified body review.
Getting a CE mark for medical devices: a step-by-step guide
Practical guidance on the CE mark for medical devices under EU MDR, from classification and evidence to conformity assessment and EUDAMED
A Practical RBQM Framework for Medical Device Trials
Risk-based quality management for medical device trials, with practical actions for risk assessment, monitoring, data review, and trial oversight
EU Breakthrough Medical Devices Under MDCG 2025-9 (BtX)
EU breakthrough medical devices gain a clearer regulatory pathway under MDCG 2025-9, with early advice and lifecycle evidence planning
What Swissmedic Fast-Track Means for Clinical Trial Sponsors
Swissmedic swissethics Fast-Track Pilot Project accelerates eligible trial reviews and makes coordinated regulatory preparation increasingly important.
FDA Breakthrough Device Acceleration
How innovative MedTech companies can accelerate FDA approval, secure Medicare coverage, and reach patients faster—starting with Breakthrough Device Designation.
This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
