In February 2026, Qualtech hosted an in-depth regulatory webinar led by Dr. Arkan Zwick, Regulatory Affairs Lead and an experienced regulatory expert with 18+ years in the medical device sector, providing a comprehensive update on the evolving European medical device regulatory landscape.
With 2026 marking a turning point in the implementation of the Regulation (EU) 2017/745 (MDR), the session covered transition deadlines, EUDAMED mandatory modules, the proposed Annex VII Implementing Regulation, and the broader MDR revision currently under legislative negotiation.
Below is a summary of the key insights shared during the session.
2026: A Critical Year for MDR Implementation
The EU Medical Device Regulation (MDR) replaced the former Directive 93/42/EEC (MDD) and became fully applicable in May 2021. However, many manufacturers remain in transition.
To prevent market disruption, the EU adopted Regulation (EU) 2023/607, extending MDR transition timelines under strict conditions.
Updated Transition Deadlines
Under Article 120 MDR:
- Until 31 December 2027
- Class III devices
- Class IIb implantable devices (excluding well-established technologies)
- Until 31 December 2028
- Class IIb implantable WET devices
- Class IIb non-implantable devices
- Class IIa devices
- Class Is (sterile), Im (measuring), Ir(reusable) devices
- Up-classified devices requiring Notified Body involvement
However, transition is not automatic. Manufacturers must demonstrate:
- Continuous compliance with MDD/AIMDD
- No significant design or intended purpose changes
- No unacceptable safety risks
- MDR-compliant QMS (since May 2024)
- MDR application submitted and written agreement signed with a Notified Body
Failure to meet these conditions results in loss of transition eligibility.
EUDAMED Goes Live: Mandatory Modules from May 2026
A major operational milestone discussed during the webinar is the go-live of mandatory modules within EUDAMED.
From 28 May 2026, the following modules become mandatory:
- Actor Registration
- UDI / Device Registration
- Notified Bodies & Certificates
- Market Surveillance
The Vigilance module is expected to follow in 2027 after audit and Official Journal publication.
Key Industry Actions
Manufacturers, Authorized Representatives, importers, and system/pack producers must:
- Obtain your Single Registration Number (SRN) (Actors ID).
- Register devices (Basic UDI-DI, UDI, Certificate information).
- Align certificate data with notified body records
- Clarify responsibility allocation among economic operators (manufacturer vs AR vs importer)
- Review legacy portfolios still placed on the market
Early preparation is critical, as EUDAMED readiness will directly affect market access.
Annex VII Implementing Regulation: Short-Term Structural Change (2026)
One of the most impactful near-term developments is the proposed Annex VII Implementing Regulation, introduced by the European Commission in December 2025.
Unlike the broader MDR revision, this act specifically harmonizes requirements for Notified Bodies.
Key Measures Introduced
Binding Maximum Timelines
- Application review & contract: 30 days
- QMS audit: 120 days
- Technical documentation review: 90 days
- Certification decision: 15 days
Parallel assessments between QMS and technical documentation will become mandatory.
Cost Transparency, Notified Body quotations must include
- Detailed cost breakdowns
- Surveillance and unannounced audit estimates
- Justification for cost increases
Targeted Re-Certification
- No full repetition of initial certification
- Focus on PMS, changes, and risk management
Notified Body performance becomes visible , mandatory monitoring of
- Timelines
- Costs
Annual public reporting to Commission and manufacturers
This reform aims to improve predictability, shorten lead times, and enhance transparency across Notified Bodies.
MDR Revision: System-Level Reform (2026–2028+)
In parallel, a broader legislative reform of the MDR is underway under the ordinary legislative procedure (European Parliament and Council negotiations).
The European Commission proposal (COM(2025)1023) introduces 31 targeted changes to address systemic inefficiencies.
Core Regulatory Shifts
Simplification & Proportionality
- Removal of fixed 5-year recertification cycles
- Wider acceptance of clinical and non-clinical data (including in silico evidence)
- Introduction of the Well-Established Technology (WET) concept
- Simplified PRRC requirements
Reduced Administrative Burden
- Narrower scope of SSCP
- Less frequent PSUR updates
- Reduced technical documentation sampling
- Longer vigilance timelines
Digitalization
- Digital Declaration of Conformity
- Digital Technical Documentation
- Remote audits explicitly enabled
Predictability
- Defined timelines for consultations (NB, EMA, SoHO)
- Greater transparency of costs
- Structured dialogue with notified bodies
- International cooperation and regulatory reliance
Innovation Pathways
- Breakthrough device framework
- Orphan medical device pathway
- Conditional certificates
- Regulatory sandboxes
The reform reflects a strategic shift: balancing strict safety standards with competitiveness, innovation, and global alignment.
Stronger EU-Level Governance
The revision also strengthens coordination mechanisms:
- Formal dispute resolution between authorities
- Expanded role for expert panels and the European Medicines Agency (EMA)
- Enhanced coordination between MDCG and Notified Body Coordination Group
- Explicit public interest mandate for Notified Bodies
What This Means for Industry
If adopted as proposed, the combined effect of Annex VII and MDR revision may result in:
- More predictable timelines and certification costs
- Greater lifecycle flexibility
- Reduced administrative burden
- Earlier patient access to innovation
- Improved international convergence
However, legislative timelines remain subject to negotiation, and scope adjustments are possible.
What Happens Next?
Two parallel tracks are shaping 2026–2027:
Annex VII Implementing Regulation
- Expected adoption: 2026
- Direct operational impact on conformity assessment timelines
MDR Revision
- Parliamentary negotiations throughout 2026
- Potential adoption: late 2026 / early 2027
- Phased application from 2027–2028 onward
Manufacturers should monitor developments closely and build regulatory scenarios into strategic planning.
Recommended Actions for 2026
- Secure MDR transition eligibility for legacy devices
- Prepare for EUDAMED mandatory registration
- Anticipate Annex VII timeline and cost implications
- Monitor MDR revision negotiations and assess portfolio impact
2026 is not a passive transition year — it is a strategic preparation year.