Mdr 745 Specialistv2.1.1

A manufacturer developing AI-based diagnostic software for detecting serious conditions needs to classify it under MDR Annex VIII and MDCG 2019-11 guidelines. This scenario involves applying classification rules, determining risk levels, and documenting the rationale for regulatory submission.

A startup creating an absorbable surgical suture must compile a technical file per Annex II/III, including GSPR compliance, risk management, and clinical evidence. This requires structuring documentation, conducting conformity assessments, and engaging a Notified Body for review.

A Notified Body assesses a manufacturer's CER for a Class III cardiac pacemaker, verifying systematic literature reviews, equivalence assessments, and PMCF plans. This ensures compliance with Annex XIV and Article 61 requirements for clinical investigations.

A company establishes a PMS system per Chapter VII, including PMS plans, PSURs, and vigilance reporting for a short-term invasive device. This involves setting up data collection, trend analysis, and annual audits to monitor safety and performance.

Offering specialized MDR compliance consulting, including device classification, technical documentation preparation, and Notified Body liaison. Revenue is generated through project-based fees or retainer contracts with medical device companies.

Providing a cloud-based platform to automate MDR workflows, such as classification matrices, GSPR checklists, and CER templates. Revenue comes from subscription plans based on user tiers and device volume.

Delivering online or in-person training courses on MDR topics like clinical evaluation and EUDAMED integration. Revenue is earned through course fees, certification exams, and corporate training packages.