EU MDR Clinical Resource Hub
A curated library of authority updates, notified body resources, published literature, and other relevant resources for EU MDR clinical and medical writing teams, currently dating back to January 2025.
01 Most Relevant
All Resources
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Notified Body Expectations · Technical Documentation
May 18, 2026
Legislation / Regulatory Update
02 High Value
European Commission / DG SANTE
Medical Devices: New Implementing Regulation sets out uniform requirements for conformity assessment and notified bodies
European Commission news item summarizing Implementing Regulation (EU) 2026/977 on uniform requirements for conformity assessment and notified bodies.
Notified Body Expectations · Technical Documentation · Regulatory Systems & Processes
Free
May 7, 2026
Webpage / FAQ
03 Worth a Scan
MedTech Europe
New EU rules: more business predictability and transparency in medtech conformity assessment
MedTech Europe frames Implementing Regulation 2026/977 as a step toward more predictable and less burdensome conformity assessment.
Notified Body Expectations · MDR / IVDR Reform
Free
May 7, 2026
Guidance
03 Worth a Scan
European Commission
Update – new manufacturer incident report PDF file (SB 11154) and important information about which MIR 7.3.1. versions are accepted from 1st May 2026
The Commission updated MIR PDF 7.3.1 and clarified which versions are accepted from 1 May 2026.
Postmarket Evidence · Regulatory Systems & Processes
Free
May 5, 2026
Position Paper
03 Worth a Scan
MedTech Europe
MDR/IVDR Revision: A regulatory system at a crossroads — Position & Proposed Amendments
MedTech Europe’s May 2026 revision paper argues for simplification, broader recognition of clinical evidence, digital submissions, and clearer AI integration.
MDR / IVDR Reform · Clinical Evaluation · Notified Body Expectations
Free
May 4, 2026
Legislation / Regulatory Update
02 High Value
European Commission / EUR-Lex
Commission Implementing Regulation (EU) 2026/977 on notified body quality management and conformity assessment requirements
Commission Implementing Regulation (EU) 2026/977 sets uniform quality-management and procedural requirements for notified-body conformity assessment under MDR and IVDR.
Notified Body Expectations · Regulatory Systems & Processes
Free
April 21, 2026
Position Paper
01 Most Relevant
Team-NB
Clinical Evaluation Based on Non-Clinical Data: EU Medical Device Regulation 2017/745 Article 61.10
Team-NB paper outlining when a manufacturer may justify reliance on non-clinical data under MDR Article 61(10).
Clinical Evaluation · Notified Body Expectations
Free
April 21, 2026
Position Paper
01 Most Relevant
Team-NB
Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745
Updated Team-NB best-practice paper for MDR technical-documentation submissions, including CEP, CER, PMCF, and SSCP sections.
Clinical Evaluation · Notified Body Expectations · Technical Documentation
Free
March 19, 2026
Legislation / Regulatory Update
01 Most Relevant
European Commission / EUR-Lex
European Commission delegated act expands WET list under MDR Article 61(8)
European Commission delegated act amending the MDR to expand the list of implantable and class III devices exempted from the obligation to perform clinical investigations.
Clinical Investigations · Clinical Evaluation · MDR / IVDR Reform
Free
March 9, 2026
Journal Article
03 Worth a Scan
npj Health Systems
Data-driven medical devices and the EU MDR: mapping gaps in standards for regulatory compliance
Open-access perspective on standards gaps for data-driven devices under MDR.
Software / SaMD / AI · Technical Documentation · Clinical Evaluation
Free
February 20, 2026
Journal Article
02 High Value
Abdominal Radiology
The AI Act and the MDR post-market requirements for semiautonomous AI SaMD: a radiology case study in prostate cancer
Open-access article mapping overlapping AIA and MDR post-market obligations for high-risk AI SaMD.
Software / SaMD / AI · Postmarket Evidence
Free
February 10, 2026
Recorded Webinar
01 Most Relevant
BSI
Demystifying Design Controls and Clinical Planning
BSI webinar linking design controls, risk management, and clinical planning into submission-ready MDR/IVDR documentation.
Design / Risk / Usability · Clinical Evaluation · Technical Documentation
Free
January 26, 2026
Recorded Webinar
02 High Value
SGS
Proposed Amendments to the MDR and Impacts to Your Submission
SGS webinar on the December 2025 MDR amendment proposal and likely effects on submissions, clinical evidence, and timelines.
MDR / IVDR Reform · Clinical Evaluation · Technical Documentation
Free
January 14, 2026
Journal Article
03 Worth a Scan
Frontiers in Public Health
Orphan medical devices: addressing the regulatory and access gaps in the EU and US
Frontiers policy review comparing EU and US approaches to orphan medical devices, including evidentiary and post-market implications.
Clinical Evaluation · Postmarket Evidence
Free
December 19, 2025
Guidance
01 Most Relevant
MDCG
MDCG 2025-10 Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices
Official new PMS guidance linking planning, data collection, analysis, reporting, and QMS feedback loops.
Postmarket Evidence · Clinical Evaluation · Technical Documentation
Free
December 12, 2025
Journal Article
03 Worth a Scan
Insights into Imaging
AI medical device post-market surveillance regulations: consensus recommendations by the European Society of Radiology
Open-access consensus statement on PMS and post-market obligations for AI medical devices in Europe.
Software / SaMD / AI · Postmarket Evidence
Free
December 12, 2025
Recorded Webinar
03 Worth a Scan
European Commission / HTACG
The EU HTA Regulation: Webinar for health technology developers of medical devices and in vitro diagnostic medical devices
Official EC/HTACG webinar explaining joint clinical assessments, joint scientific consultations, and HTA IT platform workflows for high-risk devices and IVDs.
Clinical Evaluation · Clinical Investigations
Free
November 12, 2025
Recorded Webinar
03 Worth a Scan
TÜV SÜD
Medical Device Software Regulation: successful MDR certification and how to prepare for it
TÜV SÜD webinar on MDSW certification preparation and regulatory requirements.
Software / SaMD / AI · Regulatory Systems & Processes · Clinical Evaluation
Free
September 1, 2025
Guidance
03 Worth a Scan
European Commission / MDCG
Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v4
Updated borderline/classification manual published as September 2025 on the EC guidance page.
Regulatory Systems & Processes · Clinical Evaluation
Free
July 3, 2025
Journal Article
01 Most Relevant
Therapeutic Innovation & Regulatory Science
“Appropriateness” of Clinical Data Under Regulation (EU) 2017/745 – A Case Study and Survey
Open-access article examining what may count as sufficient evidence for a Class IIb non-implantable device.
Clinical Evaluation · Notified Body Expectations
Free
July 2, 2025
Conference Recording
03 Worth a Scan
European Commission
EU health technology assessment: Advent of a new era of collaboration
European Commission conference on implementation of the HTA Regulation, including implications for devices and broader evidence planning.
Clinical Evaluation · Postmarket Evidence
Free
June 1, 2025
Webpage / FAQ
02 High Value
European Commission
Pilot coordinated assessment for CI/PS
European Commission pilot for coordinated assessment of clinical investigations and performance studies across Member States.
Clinical Investigations · Regulatory Systems & Processes · Postmarket Evidence
Free
June 1, 2025
Guidance
03 Worth a Scan
MDCG
MDCG 2025-5 Questions & Answers regarding performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746
Official IVD study Q&A published on the MDCG guidance page.
Clinical Investigations · Clinical Evaluation · Regulatory Systems & Processes
Free
May 24, 2025
Journal Article
02 High Value
npj Digital Medicine
Classification grid and evidence matrix for evaluating digital medical devices under the European union landscape
Open-access article proposing an evidence matrix for digital medical devices in the EU.
Software / SaMD / AI · Clinical Evaluation · Literature Review
Free
April 22, 2025
Journal Article
03 Worth a Scan
European Heart Journal
Priorities for medical device regulatory approval: a report from the European Society of Cardiology cardiovascular round table
Peer-reviewed perspective on device-approval priorities and predictability in Europe.
MDR / IVDR Reform · Clinical Evaluation
Paid
April 9, 2025
Whitepaper
01 Most Relevant
Team-NB
Best Practice Guidance: Technical Documentation Submission under EU MDR 2017/745 (Version 3)
Team-NB’s updated best-practice paper for technical documentation submission quality.
Technical Documentation · Notified Body Expectations · Clinical Evaluation
Free
March 27, 2025
Recorded Webinar
01 Most Relevant
BSI
Medical Device Software under the MDR – Perspectives from a Notified Body
BSI webinar on MDR requirements for software, typical gaps, and lessons learned from notified-body review.
Software / SaMD / AI · Clinical Evaluation · Notified Body Expectations
Free
February 6, 2025
Journal Article
01 Most Relevant
npj Digital Medicine
CORE-MD clinical risk score for regulatory evaluation of artificial intelligence-based medical device software
Open-access perspective proposing a structured score to scale premarket and post-market evidence expectations for AI-based medical device software.
Software / SaMD / AI · Clinical Evaluation · Postmarket Evidence
Free