EMA’s high-risk-device consultation page now includes an updated list of clinical evaluation consultation procedure (CECP) opinions already issued for devices whose conformity assessments are still awaiting finalisation.

An empirical global mapping of early feasibility studies describes how early-stage device evidence is being generated and highlights gaps relevant to a more structured European EFS framework.

A device-specific review examines MDR certification and transparency challenges for continuous glucose monitoring systems, including access to clinical evidence and delays in EUDAMED implementation.

SGS explains why MDR post-market surveillance must operate as a continuous evidence system linked to clinical evaluation, PMCF, risk management, CAPA, and technical documentation.

SGS explains what certification-body reviewers expect from MDR clinical evaluations and identifies recurring CER failure modes.

Team-NB argues that broader EU-wide access to EUDAMED vigilance and clinical-study information is needed for genuinely risk-adapted surveillance.

Revision 11 consolidates the former MDSAP Audit Model and Process Companion into one Audit Approach and updates expectations around risk-based QMS control, lifecycle risk-management oversight, personnel competence, cybersecurity and postmarket feedback, PCCPs, UDI, and jurisdiction-specific requirements.

EMA authors review Article 117 implementation for integral drug-device combinations and the interface between medicinal-product and medical-device requirements.

This review systematically maps benefit–risk assessment requirements and methodologies for medical devices, with a primary focus on EU MDR and related regulatory sources, and distinguishes how benefit–risk assessment operates across different lifecycle and regulatory contexts.

A cross-company survey assesses the current operational impact of MDR/IVDR implementation on manufacturers of different sizes.

MDCG clarifies that UDI-DIs for distributor-branded devices must still be assigned and legally linked to the manufacturer.

The Commission publishes Member State summaries of 2025 annual monitoring and on-site assessments of MDR/IVDR notified bodies.

The European Commission updates the medical-device submission request template used in the EU HTA framework.

Dashboard version 3.5 updates Commission monitoring data on medical-device availability, notified-body activity, and economic-operator experience.

The Commission refreshes its consolidated list of notified bodies’ publicly available standard fees.

BSI explains how Implementing Regulation (EU) 2026/977 changes Annex VII requirements affecting notified-body quotations, timelines, interruptions, monitoring, and recertification.

Team-NB proposes a risk-adaptive surveillance model that would vary ongoing oversight intensity by device and manufacturer risk.

This scoping review examines how the EU handles early feasibility studies and where the current framework leaves innovators and regulators with fragmented pathways.

A June 2026 multisociety consensus paper offers indication-specific recommendations for study design, endpoints, safety monitoring, transparency, and post-market evidence generation.

A scoping review maps methods for generating and evaluating clinical and performance evidence for high-risk and innovative medical devices and IVDs across the lifecycle.

Official HTACG webinar explaining JCA, JSC, and related guidance for high-risk devices and IVDs.

MDCG clarifies how SS(C)Ps will be handled in EUDAMED after the first four modules became mandatory.

Team-NB outlines its position on how micro and small manufacturers should be supported under MDR.

A joint stakeholder statement raises concerns about the Commission’s WET delegated regulations and asks for further refinement.

Team-NB sets out a harmonised view of MDR pre-application, application, and post-application phases for notified-body certification.

MedTech Europe argues that the Commission’s simplification proposal should shift MDR/IVDR oversight toward a more risk-based life-cycle model.

Team-NB survey report on manufacturers’ MDR transition progress and technical-documentation submission readiness.

Team-NB post sharing a legal expert opinion on proposed MDR Article 50 fee and access provisions.

European Commission news item summarizing Implementing Regulation (EU) 2026/977 on uniform requirements for conformity assessment and notified bodies.

The Commission highlights that EUDAMED use becomes mandatory from 28 May 2026 for the first four modules.

MedTech Europe frames Implementing Regulation 2026/977 as a step toward more predictable and less burdensome conformity assessment.

The Commission updated MIR PDF 7.3.1 and clarified which versions are accepted from 1 May 2026.

MedTech Europe’s May 2026 revision paper argues for simplification, broader recognition of clinical evidence, digital submissions, and clearer AI integration.

Commission Implementing Regulation (EU) 2026/977 sets uniform quality-management and procedural requirements for notified-body conformity assessment under MDR and IVDR.

Commission update publishing MIR 7.3.1 support files for manufacturer database implementation.

Updated borderline/classification manual published as version 5 on the EC site.

Team-NB paper outlining when a manufacturer may justify reliance on non-clinical data under MDR Article 61(10).

Updated Team-NB best-practice paper for MDR technical-documentation submissions, including CEP, CER, PMCF, and SSCP sections.

Updated official classification guidance published as MDCG 2021-24 rev.1 in April 2026.

Team-NB feedback package on the targeted MDR/IVDR revision.

Official Article 10a Q&A update plus decision tree for supply interruption/discontinuation notifications.

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.

European Commission high-level conference on system performance, innovation, and patient safety.

BSI webinar on human factors and usability engineering in MDR/IVDR compliance.

Open-access perspective on standards gaps for data-driven devices under MDR.

TOPRA course on regulatory strategy for drug-device combinations and related technologies.

Team-NB document-page entry showing a new 2026 paper on MDR/IVDR revision impact.

GMED training focused on systematic literature review methods for medical devices.

Official HTACG subgroup meeting page for joint clinical assessments on 24 February 2026.

Official HTACG subgroup page for identifying emerging health technologies.

Open-access article mapping overlapping AIA and MDR post-market obligations for high-risk AI SaMD.

Official HTACG meeting page for the 12 February 2026 meeting.

BSI webinar linking design controls, risk management, and clinical planning into submission-ready MDR/IVDR documentation.

Commission onboarding page for mandatory EUDAMED use.

SGS webinar on the December 2025 MDR amendment proposal and likely effects on submissions, clinical evidence, and timelines.

DQS interpretation of the new PMS guidance in more operational language.

Frontiers policy review comparing EU and US approaches to orphan medical devices, including evidentiary and post-market implications.

BSI webinar on practical risk mapping for MDR/IVDR-ready development.

Official new PMS guidance linking planning, data collection, analysis, reporting, and QMS feedback loops.

Commission evaluation supporting the simplification proposal.

Commission proposal to simplify and reduce burden under MDR and IVDR.

Open-access consensus statement on PMS and post-market obligations for AI medical devices in Europe.

Official EC/HTACG webinar explaining joint clinical assessments, joint scientific consultations, and HTA IT platform workflows for high-risk devices and IVDs.

Brussels session of the official EUDAMED workshop series.

Official guidance for the EU breakthrough-devices pilot.

Commission timeline showing phased EUDAMED rollout and mandatory-use milestones.

Commission announcement confirming the legal trigger date for mandatory use of the first four modules.

TÜV SÜD webinar on MDSW certification preparation and regulatory requirements.

MedTech Europe paper arguing for proportionate PMCF expectations.

Official follow-on EUDAMED workshops with the same onboarding content as Stuttgart.

MedTech Europe summary of the Commission call for evidence on future MDR/IVDR reform.

Updated borderline/classification manual published as September 2025 on the EC guidance page.

Updated UDI implementation guidance listed as August 2025 on the MDCG page.

Team-NB / NBCG-Med paper on future governance changes.

Open-access article examining what may count as sufficient evidence for a Class IIb non-implantable device.

European Commission conference on implementation of the HTA Regulation, including implications for devices and broader evidence planning.

RAPS article on designing and executing stronger PMCF surveys under MDR.

TOPRA introductory medical-device course for teams building core EU device regulatory capability.

Official FAQ addressing MDR/IVDR and AI Act overlap.

European Commission pilot for coordinated assessment of clinical investigations and performance studies across Member States.

Official IVD study Q&A published on the MDCG guidance page.

Official software-focused MDCG guidance.

TÜV SÜD webinar on the Commission guidelines for defining an AI system under the AI Act, with medical-device focus.

Open-access article proposing an evidence matrix for digital medical devices in the EU.

Official EUDAMED workshop with presentations and onboarding material.

BSI webinar focused specifically on clinical evaluation challenges for software as a medical device.

Peer-reviewed perspective on device-approval priorities and predictability in Europe.

Team-NB’s updated best-practice paper for technical documentation submission quality.

GMED newsletter summarizing MDR/IVDR PMS requirements and their documentation links.

BSI webinar on MDR requirements for software, typical gaps, and lessons learned from notified-body review.

MedTech Europe report detailing burden drivers under MDR and IVDR.

Joint MedTech Europe paper pressing for earlier high-level clinical-strategy dialogue with notified bodies.

Updated IVD classification guidance listed as March 2025 on the MDCG page.

Open-access perspective proposing a structured score to scale premarket and post-market evidence expectations for AI-based medical device software.

Official roadmap of MDCG subgroup work for 2025.

Official EMDN version-history record.

Updated MDR PAR template referenced on the MDCG guidance page.

Official summary of EMDN submissions and annual revision outcomes.

Official EMDN procedure update published on the MDCG guidance page.

Updated IVDR PAR template referenced on the MDCG guidance page.