MDR · IVDR · controlled regulatory work
Make the compliance work visible
Eight focused checklists for the documents, systems and decisions behind CE marking.
A regulation tells you what must be achieved. A useful checklist turns that obligation into work that can be assigned, evidenced, reviewed and kept current.
Choose a checklist ↓Select the right control surface before the work starts.
The useful boundary
A checklist creates control, not conformity by itself
Use it to expose missing work and evidence. Do not treat a row of ticks as a substitute for regulatory judgment.
- Translate a broad requirement into reviewable tasks
- Connect each task to an owner, record and due date
- Reveal gaps before an audit or dossier assessment
- Support consistent updates after product changes
- Decide automatically which requirements apply
- Replace technical, clinical or quality evidence
- Resolve contradictions between controlled documents
- Guarantee certification or regulatory acceptance
Checklist library
Start with the workstream that owns the risk
Showing 8 resources
MDR technical documentation checklist
Organise the Annex II and Annex III dossier around device definition, GSPR evidence, design and manufacturing information, risk management, verification, validation and post-market documentation.
Open checklist ↗IVDR technical documentation checklist
Structure an IVDR dossier covering intended purpose, classification, design, manufacturing, performance evaluation, analytical and clinical performance, stability and post-market evidence.
Open checklist ↗Technical documentation checklist for medical device software
Connect software architecture, lifecycle records, risk controls, usability, cybersecurity, verification, validation, version identification and clinical evidence in one controlled dossier.
Open checklist ↗MDR-compliant quality system documentation checklist
Review whether the quality system addresses regulatory strategy, management responsibility, resource control, product realisation, suppliers, CAPA, vigilance and post-market processes.
Open checklist ↗Quality system documentation checklist for medical device software
Adapt the quality system to software development, configuration, release, change control, problem resolution, outsourced components, cybersecurity maintenance and post-market updates.
Open checklist ↗Clinical Evaluation Plan checklist
Check the planned scope, clinical claims, state of the art, data sources, appraisal methods, evidence gaps, benefit-risk questions and PMCF strategy before the evaluation begins.
Open checklist ↗Clinical Evaluation Report checklist
Test whether the report supports the intended purpose, clinical benefits, safety and performance claims, residual risks, benefit-risk conclusion and continuing evidence plan.
Open checklist ↗Strategy for regulatory compliance SOP checklist
Build a controlled procedure for regulatory routes, product changes, applicable requirements, economic operators, registrations, certification maintenance and regulatory intelligence.
Open checklist ↗Use method
Turn every checkbox into a traceable handoff
The value comes from the evidence linked to each item and the decision made when that evidence is incomplete.
Confirm the scope
Define the product, regulation, route, class and lifecycle stage before choosing the checklist.
Remove what is not applicable
Document why an item does not apply. Do not delete difficult requirements without an assessment.
Name the owner and evidence
Connect each applicable item to a responsible person, controlled record, dependency and target date.
Challenge completion
Check substance, consistency and approval—not merely whether a document with the expected title exists.
Completion test
Do not ask only “Is it checked?”
Ask whether the evidence is current, approved, internally consistent and tied to the released product configuration.
A completed checklist should make the regulatory story easier to verify—not merely easier to count.
From generic list to product-specific control
Need to adapt a checklist to your device and conformity route?
MDRC can help translate the applicable requirements into owned work packages, evidence expectations and a realistic readiness review.
