EU Medical Device Regulation Timeline
This includes past and estimated timing for future events:
1. 2014: Parliament 1st reading, Parliament elections, New Commissioners on the job.
2. 2015: EU Council reaches partial agreement on the approach, Trilogues start.
3. 2016: Trilogues end.
4. 201X: Comes into force (MDR/IVDR, Clicicals, EU oversight, Special NBs, EUDAMED, USI, Electronic submission.
Brief comments/references on each MDR chapter regarding Clinicals
Joint audits by NBs - 920/2013EC
Clinical experts (iinternal/external) contribute. RISK: reassessment of already approved files (suspension, cancellation).
Clinical trial evaluations by outside expert: RISK: Notice loss, scope reduction, cancellation.
Annex's I, II, III: criteria for NBs.
New Guides: MEDDEV 2.7.1 Clinical Evaluation, MEDDEV 2.7.2 Authorities on approving Clinical Trials, MEDDEV 2.7.3 Adverse Event Reporting.
Chapter I: Non- viable human tissue, aesthetic products included after defining common specifications.
Chapter II: ISO 14155 remains the basis for Common Specifications,safety, performance, clinicals. unknown: liability chain.
Chapter III: Transparency (UDI, safety/clinical performance) agreed.
Chapter IV: NB system continues, tighter control on high risk NBs.
Chapter V: Risk classes & choice of conformity routes remain, increased classification to class III.
Chapter VI: Class III requires clinicals, equivalence only for line extensions, annual clinical summary update.
Chapter VII: More market surveillance and vigilence reporting, safety updates.
Chapter VIII: Commission seeks more external expertise for state of the art, manufacturers/NB pay for work done.
Chapter IX: Increased detail on confidentiality, Data Protection.
Chapter X: Final provisions agreed by all.
Overall: Increased focus on clinical trials, and clinical data, equivalence limited, no 'grandfathering'.