What it is
What is the MDR?
The MDR is a comprehensive regulatory framework enforced across the EU, governing the production and distribution of medical devices. It became fully applicable on 26 May 2021. Transition periods for legacy devices were extended (to 2027 or 2028 depending on risk class) — but only for manufacturers meeting strict conditions.
- Increased clinical evidence and post-market surveillance
- More detailed technical documentation
- Stricter requirements for high-risk devices
- Greater transparency through the EUDAMED database
- Mandatory Person Responsible for Regulatory Compliance (PRRC)
Why it matters
Why MDR compliance is important
- Legal market access across the EU
- Demonstrated commitment to safety and quality
- Protection against legal liability and recalls
- Transparency that strengthens clinician and patient confidence
How we help
Our MDR services
- Gap analysis and MDD-to-MDR transition planning
- Technical documentation creation and updates (Annex II & III)
- Clinical evaluation report (CER) preparation
- Post-market surveillance (PMS) and PSUR planning
- EUDAMED registration and PRRC support
- Notified Body submission and query management
01
MDR specialists
In-depth knowledge of EU regulatory requirements and Notified Body expectations.
02
Regulatory alignment
Your QMS aligned to both ISO 13485 and MDR requirements.
03
End-to-end support
From initial gap check to Notified Body submission.
04
Timely execution
Reduced time-to-market and lower audit risk.
The regulatory journey
From regulatory strategy to MDR approval
- 01Framework identificationWe confirm the regulatory pathway that applies to your product and target market — MDSAP, MDR, FDA, TGA or MHRA.
- 02Regulatory strategyDevice classification, pathway selection and a realistic timeline to support launch planning.
- 03Technical documentationRisk management, clinical/performance evidence, labeling and QMS records built to each authority’s expectations.
- 04Submission and liaisonWe prepare and submit the application, manage questions from the authority or Notified Body, and track progress.
- 05Approval and market accessClearance, CE or UKCA marking, ARTG inclusion or registration, enabling your product to be placed on the market.
- 06Post-market complianceOngoing surveillance, vigilance, periodic updates and renewals to maintain compliance.
