Post-Market Services for UK MDR, EU MDR & IVDR Compliance
Support across post-market clinical follow-up, surveillance planning, and ongoing regulatory evidence management to meet Articles 83–86 (MDR) and 78–81 (IVDR).
Post-Market Clinical Follow-up (PMCF)
Strategic development of PMCF Plans aligned with MDR Annex XIV Part B and MDCG 2020-7. Tailored to address clinical uncertainties and support long-term safety and performance data identification and collection.
Generation of compliant PMCF Evaluation Reports, analysing data from clinical experience, literature, or studies, feeding directly into the CER and ongoing conformity assessment.
Post-Market Surveillance (PMS) System Development
Creation of risk-based PMS Plans that integrate reactive and proactive sources, in accordance with MDR Article 84 and MDCG 2023-4.
Comprehensive PSURs for Class IIa/IIb/III devices and Class C/D IVDs, providing a clear summary of benefit-risk evolution, PMS data trends, and field safety actions.
Clear, structured PMS Reports for Class I medical voices and Class A/B IVDs summarising results and conclusions of planned PMS activities.
Preparation of SSCPs for Class III and implantable devices, ensuring alignment with Article 32 and MDCG 2019-9. Includes dual-targeted content for healthcare professionals and patients.
Navigating your post-market obligations under EU MDR or IVDR?
Explore our expert guidance on Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) — including practical tips for planning, reporting, and maintaining ongoing regulatory conformity.
Ongoing Literature Monitoring and SotA Updates
We maintain up-to-date systematic literature surveillance programs and revise SotA reports to reflect new clinical evidence or standards of care across the device lifecycle.
Expert Review of Notified Body & Authority Feedback
We support manufacturers in responding to Notified Body findings and Competent Authority queries related to clinical and performance evidence, offering clear, strategic responses and rebuttals.
Lifecycle Clinical Data Strategy & Evidence Management
We advise on lifecycle-integrated clinical data strategies, ensuring your technical documentation remains current and inspection-ready as your device evolves.
Your responsibilities don’t end at CE marking — under the EU MDR and IVDR, manufacturers must proactively monitor device safety and performance through structured post-market surveillance (PMS) and post-market clinical follow-up (PMCF) systems. Our consultancy supports you in planning, executing, and documenting these obligations with precision and regulatory confidence.
Whether you're preparing a PMCF Plan, authoring a PSUR, or navigating Notified Body feedback, we deliver science-based, audit-ready outputs that align with the latest MDCG guidance and evolving industry expectations.