The Medical Device Regulation (EU) 2017/745 replaced the Medical Device Directive in May 2021. Five years in, manufacturers still wrestle with its expanded scope, stricter clinical requirements and lifecycle obligations.
1. Expanded scope and reclassification
Several device categories have been reclassified upward. Software as a Medical Device (SaMD) in particular now sits in Class IIa or higher under Rule 11, dragging in notified body involvement that didn't exist under MDD.
2. Clinical evidence is non-negotiable
Equivalence claims are tightly restricted. PMCF is essentially mandatory. Literature-only justifications are scrutinized line-by-line.
3. UDI, EUDAMED and traceability
Every device requires a UDI-DI and must be registered in EUDAMED. The system is becoming gradually mandatory through 2027 — start now.
4. PRRC and quality system maturity
Article 15 introduces the Person Responsible for Regulatory Compliance. Combined with ISO 13485:2016, your QMS has nowhere to hide.
What to do next
Audit your technical file against MDR Annex II line by line. Most legacy MDD dossiers fail at GSPR conformity, clinical evaluation depth, and PMS planning. Closing those three gaps closes 70% of the work.