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EU MDR Templates, Documents & Tools
Become self reliant when writing your technical documents
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Powerful & customisable, engineered for success
Build your technical file through proven frameworks enhanced by detailed guidance from our specialists.
- Eliminate doubt when building EU MDR systems
- CERs, CEPs, Risk Management & more
- Freedom to choose the resources you need
- Step-by-step guidance from EU MDR experts
- Direct, immediate & future-proof access
Choose what you need
Pick from our library of EU MDR resources and use your existing product knowledge to build your medical device technical files.
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Build MDReady Starter Guide Free Download
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Build Gap Analysis Tool Evaluation Checklist
Quickly evaluate your regulatory strategy against EU MDR requirements for all your medical devices
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Build CER Template Guidance Document
Produce Clinical Evaluation Reports for any class of medical device using a proven start-to-finish methodology
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Build CEP Template Guidance Document
Produce Clinical Evaluation Plans for any class of medical device using a proven structure designed by experts
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Build Risk Management Templates Technical Documents
Build an adaptive & ISO 14971:2019-compliant Risk Management system for all your medical devices
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Build Annex II Templates Technical Documents
The comprehensive solution to producing EU MDR Annex II technical documents for your medical devices
EnableCE Learn Online EU MDR Video Training Courses
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Choose from our range of professional online video training courses suitable for any existing level of regulatory knowledge.