WHITEPAPER
The EU AI Act meets MDR
Everything AI-enabled medical device manufacturers need to know.
This whitepaper outlines obligations that arise when AI functions make a device, or its safety component, subject to both MDR and the EU AI Act. It frames risk classification, AI management systems, documentation depth, and conformity assessment touch points with notified bodies. It helps plan a more integrated compliance approach across development, testing, deployment, and post-market phases for AI-incorporated medical devices.
GUIDE
Conformity Assessment Routes
A comparison of MDR Annex routes, device class implications, and when to use product-specific versus QMS-based pathways.
A summary of MDR conformity assessment options by device class and regulatory scenario. It contrasts product-specific and QMS-based routes, clarifies documentation and sampling expectations, and points to when additional consultations (e.g., expert panels) are triggered. Use it to select the most efficient pathway for your product portfolio and to plan evidence generation, timelines, and notified body interactions accordingly.
GUIDE
MDR Documentation Submission: Best Practice Guidelines
How to convey clinical evidence, synchronize versions, and support your clinical route to conformity without submission gaps.
A practical companion for preparing MDR submissions, this guide shows how to align CEP/CER content, define outcome measures, and tie clinical evidence and traceability to relevant GSPRs. It emphasizes version control, explicit intended purpose/indications, risk methods, and benefit-risk acceptability parameters. Use its checklists to ensure your technical file reports a consistent, audit-ready status across all modules and lifecycle documentation phases.
WEBINAR
Medical Device Software Under the MDR: Perspectives from a Notified Body
NB expectations on Rule 11 classification, key GSPRs, core software standards, and what your technical file must demonstrate.
Presented from a Notified Body (NB) perspective, this session clarifies the EU concept of "software as a medical device" (SaMD) independent of a dedicated hardware platform, Rule 11 classification outcomes, and the most-applied conformity standards (EN 62304, EN 82304-1, EN 62366-1). It highlights what NBs look for, such as platform/OS constraints, cybersecurity controls, lifecycle traceability, software updating, usability engineering, and validation of performance claims. A concise roadmap to building a software certification evidence pathway under MDR.
WEBINAR
Clinical Evaluation of Medical Device Software
What counts as "clinical data" for software used in medical devices, planning Annex XIV evaluations, and avoiding common software-specific regulatory pitfalls.
This webinar explains how to scope and execute clinical evaluations for software, distinguishing non-clinical algorithm testing from true clinical data generated in real use. It covers intended purpose, state of the art, risk-based evidence planning, and PMCF considerations for medical device software. Manufacturers learn how assessors interpret Article 61, GSPRs, and Annex XIV as they related to software used in medical devices, and how to document expertise, methods, and conclusions that help satisfy notified body review.
GUIDE
Best Practice Guidance: Submission of Clinical Evaluation Documentation for Conformity Assessment by the Notified Body
Practical instructions for aligning CEP, CER, PMS/PMCF content and update cadence to MDR Annex XIV expectations.
A detailed guide for MDR clinical evaluation documentation. It explains how to structure the Clinical Evaluation Plan and Report, define intended purpose, outcomes, and benefit-risk parameters, and maintain consistency across the technical file. The guidance flags common pitfalls (misaligned versions, vague claims) and outlines documentation for higher-risk classes and special device categories, helping teams avoid notified body challenges and refusals.
WHITEPAPER
Article 61.10: Clinical Evaluation Based on Non-Clinical Data
When and how to justify reliance on non-clinical evidence for certain lower-risk devices.
An explanation of the admittedly narrow conditions under which Article 61.10 may apply, the types of devices typically suitable, and why insufficient clinical data alone is not a valid justification. The paper contrasts non-clinical and clinical data, introduces "indirect" clinical evidence, setting expectations for documentation and argumentation. Essential reading for manufacturers considering 61.10 to avoid refusals and to shape realistic clinical strategies.
WEBINAR
Interplay of Medical Devices and AI
Mapping MDR and the EU AI Act for AI-enabled devices including classification, high-risk obligations, documentation, and change control.
This webinar connects MDR obligations with the EU AI Act for all AI-enabled (including non-medical) devices. It outlines high-risk AI requirements, the role of AI-focused technical documentation, post-market and change-management expectations, and areas like drift, bias, cybersecurity, and human oversight. It covers assessment pathways during and after the transition period, preparing unified MDR/AI evidence and lifecycle controls.
GUIDE
CE Certification with BSI: Certification Process under Medical Devices and IVD Regulations
Step-by-step overview of BSI's MDR/IVDR application, technical documentation review, QMS audits, decisions, and post-certification surveillance.
This guide walks manufacturers through BSI's MDR/IVDR conformity assessment from initial proposal and contract, through QMS Stage 1/Stage 2 audits and technical documentation review, to certification decision and EUDAMED notification. It highlights sampling approaches, particular cases (e.g., medicinal substances, human/animal tissues, Class D IVDs), language and submission expectations, and ongoing surveillance activities.
