MDCG Pre-Registration Assessment case studies
MDCG Pre-Registration Assessment · Put your knowledge to work in context.
The MDCG Pre-Registration Assessment is an independent study credential for professionals preparing to submit medical device or IVD documentation under the EU MDR 2017/745 and IVDR 2017/746. It targets regulatory affairs specialists, quality managers, notified body reviewers, consultants, and clinical/performance evaluation staff who need to demonstrate command of the pre-registration phase: classifying devices, selecting conformity assessment routes, assembling Annex II/III technical documentation, planning clinical or performance evaluation, and applying MDCG guidance. The MDCG Pre-Registration Assessment case studies are 5 cases and about 3,251 words.
1AI Triage Software for Intracranial Haemorrhage: Rule 11 and Clinical Evidence
An SME has developed a cloud-based deep learning tool, NeuroFlag, that analyses non-contrast CT head images and places suspected intracranial haemorrhage cases at the top of the radiology worklist. The intended purpose states it is a 'triage aid for trained radiologists; it does not replace primary reading'.
704 words, about 4 min2Companion Diagnostic for a KRAS Inhibitor: IVDR Classification and Article 48 Consultation
An IVD manufacturer has a real-time PCR kit that detects KRAS G12C mutations in formalin-fixed paraffin-embedded tumour tissue. The kit is intended to identify patients with non-small cell lung cancer who may be eligible for a specific targeted therapy.
659 words, about 3 min3Legacy Infusion Pump and Article 120: Can We Keep Shipping?
MediFlow GmbH manufactures a Class IIb infusion pump for intravenous chemotherapy. The device is covered by an MDD certificate issued by a notified body that expires on 26 May 2024.
652 words, about 3 min4Sterilisation Supplier and Raw Material Change: QMS and Risk Management Gaps
During a pre-registration assessment for a Class IIa sterile single-use syringe, the notified body's auditor reviews the manufacturer's supplier controls. The syringe is sterilised by a contract facility in another member state.
641 words, about 3 min5PMCF for a Novel Coated Hip Implant: Is the Plan Sufficient?
A manufacturer has developed a ceramic-on-ceramic total hip replacement with a novel diamond-like carbon coating. The device is Class III under MDR Rule 8 (implantable).
595 words, about 3 min