An extensive library of ready-to-use EU MDR Annex II technical document templates.
Device description & specification
- Device description & specification
- Implementing UDI
- Risk classification as per MDR Annex VIII
Information to be supplied by manufacturer
- Labelling & IFU
Design & manufacturing information
GSPRs
- General Safety and Performance Requirements
- Standards and Common Specifications
Benefit-risk analysis and risk management
Product verification and validation
- Connected devices
- Devices containing CMR or endocrine disrupting substances
- Devices incorporating medicinal substances
- Devices utilising tissue and cells of human or animal origin
- Devices with a measuring function
- Instructions for SSCP
- MRI safety of implants
- Packaging and transit testing
- Product validation and verification
- Reprocessing of devices
- Rule 21 devices
- Sterilisation procedures
EU Declaration of Conformity
Annex II and III documents Checklist
Quick guide - Annex II Templates - Edition 1
Choose from our range of professional resources and use your existing product knowledge to build your medical device technical files
Services
Mantra Systems provides professional MDR & IVDR consulting services to companies seeking compliance & market access for any class of medical device.
Resources
Our free EU MDR Compliance Guide covers 24 topics relating to Medical Device Regulation. It's a great starting point to help direct your regulatory strategy.
Resources
Read our analysis and get guidance on medical device regulatory requirements including our observations on developments in the industry.
If you have any questions about our resources or would like a free & confidential discussion about your medical device, we'd love to hear from you.