SciMed’s
A free monthly digital magazine for Clinical, Regulatory & Quality teams: MDR/IVDR updates, Clinical Evaluation deep dives, PMCF & PMS guidance.
MedTech Horizon
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Written by Senior MedTech Regulatory Specialists
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Is Your AI-Enabled Medical Device Creating Regulatory Debt?
Will your AI-enabled medical device be classified as high-risk under the EU AI Act? This article explains how the AI Act interacts with MDR and IVDR, why classification is only the beginning, and how manufacturers can avoid creating regulatory debt through stronger governance, evidence, and lifecycle planning.
Legacy-Device CER Updates Under MDR
Many legacy-device Clinical Evaluation Reports fail MDR review for the same recurring reasons: outdated equivalence claims, frozen state-of-the-art sections, weak literature methodologies, disconnected PMCF evidence, and unsupported benefit-risk conclusions. This article examines the most common gaps identified during CER updates and explains how manufacturers can address them before they become costly review findings.
EU MDR Post-Market Surveillance: Building a Continuously Audit-Ready Evidence System
EU MDR has transformed post-market surveillance from a periodic compliance exercise into a continuously operating evidence system. Increasingly, Notified Bodies are not assessing individual PMS, PMCF, CER, Risk and PSUR documents in isolation, they are assessing the integrity of the evidence thread connecting them.
In this article, SciMed’s MD Alastair Selby explores why many otherwise well-written PMS systems fail under audit scrutiny, how evidence fragmentation creates operational and regulatory risk, and what a sustainable, continuously audit-ready MDR surveillance system looks like in practice.
From state-of-the-art monitoring and PMCF integration to lifecycle governance and benefit-risk consistency, he examines the operational realities manufacturers now face several years into MDR enforcement, and the practical steps required to maintain a coherent, defensible evidence ecosystem over time.
Medical Device Claims Under EU MDR and UK MDR
Making claims about a device appears deceptively simple as a statement about what a device does. But in regulatory practice - especially under the EU MDR and UK MDR - claims are far more than that. They define the device’s intended purpose, which not only describes what the device is designed to do but also dictates the regulatory scope of the device itself.
Building a Defensible Clinical Literature Review
A poorly planned literature review can lead to insufficient evidence, regulatory delays, and increased scrutiny from notified bodies. Many compliance challenges arise not from a lack of data, but from poorly designed literature strategies, making the quality of the review process critical to a defensible clinical evaluation.
12 Reasons Your CER Might Fail a Notified Body Review in 2026
Notified Body reviewers approach CERs differently than they did three years ago. The evidential bar has risen, scrutiny on equivalence claims has tightened, and structural weaknesses that once passed without comment now generate major findings. This article covers the twelve failure modes we see most often — and what needs to change in each case.
Spotlight on the Clinical Evaluation Process
Clinical Evaluation is more than documentation. It is an ongoing process of analysing evidence, assessing safety and performance, and demonstrating that a medical device delivers clinical benefit throughout its lifecycle.
MDR Clinical Data - New for 2026
In December 2025, the European Commission proposed targeted amendments to the EU medical device framework aimed at simplifying MDR and IVDR requirements. Among the most significant changes are broader acceptance of clinical and non-clinical data, more flexible equivalence provisions, and the introduction of “well-established technologies” for legacy devices - developments that could reshape clinical evidence strategies in 2026 and beyond.
How to Build a Compliant PMS System
A compliant Post-Market Surveillance (PMS) system is not a reactive process. Under the EU Medical Device Regulation, it must proactively collect, analyse, and feed post-market data back into risk management, clinical evaluation, and corrective actions to demonstrate ongoing safety and performance throughout the device lifecycle.
EU MDR Clinical Evaluation for MedTech Start-Ups
For MedTech start-ups, clinical evaluation under the EU MDR is no longer a box-ticking exercise - it’s a strategic part of product development. By planning early, leveraging existing evidence, and embedding regulatory thinking from day one, companies can turn compliance into a competitive advantage and a pathway to credible market entry.
Proving Safety Without Clinical Investigations
This article outlines how clinical evaluation under the EU MDR can, in certain cases, be conducted without new clinical trials, and explains the regulatory pathways, evidence requirements, and role of PMCF in demonstrating safety and performance.
MDR Clinical Data in 2025
This article outlines the types of clinical data sources that are accepted, identifies common sources of non-compliance, and provides practical guidance for building a robust, compliant clinical evidence strategy under the MDR framework.
How to Prepare a Clinical Evaluation Plan Aligned with MDR Annex XIV
Under MDR Annex XIV, the CEP is your anchor document. Define scope, map data, integrate risk and PMS, and show foresight. A robust CEP reassures notified bodies and builds a sustainable compliance framework for product safety and performance.
How to Update your Clinical Evaluation for Legacy Devices
MDR demands stronger clinical justification for legacy devices. Whether relying on WET status, Article 61(10), or targeted PMCF, manufacturers need structured Clinical Evaluation planning to demonstrate compliance and safeguard CE certification.
Is Your Clinical Evaluation MDR-Ready?
A structured guide to Article 61 and Annex XIV clinical evaluation requirements, and what “MDR-ready” truly means under current Notified Body scrutiny.
UK PMS Regulations vs EU MDR
Whilst the UK's new post-market surveillance requirements under SI 2024/1368 deliberately mirror the EU MDR, the differences matter in practice. A mandatory PMS Plan for all device classes, revised report update intervals, new PSUR content requirements around UK population estimates, and a separate PMSR vs PSUR determination based on UK classification all mean an EU MDR-compliant system needs reviewing before it can be considered compliant in Great Britain.
This article walks through who the regulations apply to, how the UK and EU frameworks compare side by side, which document type is required for which device class, and what specifically needs to change in an existing system to meet MHRA expectations.