Practical reference articles for EU MDR, FDA, ISO standards and market entry — each referenced to specific articles, annexes and standards. No generic summaries.
Everything a manufacturer needs to understand about the European Medical Device Regulation — from device classification and technical file requirements through clinical evidence, EUDAMED registration, UDI, and post-market surveillance. Referenced to specific EU MDR articles throughout.
25 documentation requirements across 7 compliance areas — each mapped to a specific EU MDR article or standard. Class I through Class IIb devices.
Device classification, technical file, clinical evidence, EUDAMED, UDI and PMS — all referenced to specific articles.
What every section of your technical documentation must contain and what notified bodies scrutinise first.
What clinical data your device actually needs and how the equivalence pathway works under Article 61(4).
Actor registration, device registration, UDI assignment and EU Authorised Representative requirements.
What a Post-Market Clinical Follow-up Plan must contain and how to structure it for notified body acceptance.
Legacy certificates, Article 120 transitional provisions and what changes to your technical file.
Predicate strategy, substantial equivalence, special controls and what US FDA reviewers look for.
How to find, evaluate and document a predicate that gives your submission the strongest possible equivalence case.
What changes when you target the US market alongside EU or UK — and what your QMS needs to address.
Annual registration requirements, foreign manufacturer obligations and the FURLS system explained.
Clause-by-clause breakdown of what auditors check and the documentation gaps most manufacturers carry.
What changed in the 2019 revision, how your risk management file must be structured and what benefit-risk evaluation requires.
Essential performance, basic safety, EMC under IEC 60601-1-2 and how particular standards apply to your device.
Formative and summative evaluation requirements and why absence of a usability file is a recurring non-conformity.
Where to start, what NMPA experience transfers, and the documentation your notified body will require.
Practical pathway from CDSCO-registered device to FDA clearance — what transfers and what needs to be built.
Specific guidance for Sialkot and Pakistani stainless steel instrument manufacturers targeting European markets.
How MFDS-registered devices map to EU MDR requirements and what Korean manufacturers typically need to address.