European Commission updates on MDR and IVDR implementation timeline
The European Commission updated its “rolling plan” for adopting implementing acts and other actions/initiatives ahead of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
The update follows the delay of implementation of the MDR by one year amid COVID-19 and the decision to postpone Eudamed’s rollout by two years last December.
The plan is divided into two sections: implementing acts, and other actions/initiatives.
The part Implementing acts contains following subjects:
- Notified bodies scope of Designation
- Reprocessing of single-use medical devices
- Common specifications for products without a medical purpose
- Setting up of expert panels
- Setting up of expert laboratories
- Setting up of new structures under IVDR: – EU reference laboratories
- Rules to facilitate fulfilment of tasks by EU reference laboratories and to ensure their compliance with criteria
- Fees for EURL services
- Unique Device Identification (UDI) System: designation of issuing entities
- EUDAMED
- Common specifications for IVD Class D
The part Actions/initiatives (other than implementing regulations/acts) contains following subjects:
- Notified Bodies designation
- EUDAMED go-live
For more information, please see the original Implementation rolling plan document from European Commission or download it from the EC website.
Meditrial can help – Contact us for immediate support
Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:
- Identify patients requiring follow-up
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Contact Meditrial for immediate assistance in Europe or the US.
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.
