MDR and IVDR Technical Documentation
The technical documentation is where a Notified Body sees your entire device, its design, evidence, risk profile, and claims, assembled in one place. Under the EU MDR (2017/745) and IVDR (2017/746), it has a defined structure and no room for gaps, and reviewers now sample technical files even after certification. EvySaif compiles and authors the technical documentation that presents your device as a coherent, evidence-backed whole.
What the technical file must contain
MDR Annex II and IVDR Annex II define the core technical documentation, with Annex III covering the post-market surveillance element. The connective tissue of the whole file is traceability: every claim must trace to the evidence that supports it, and every applicable GSPR clause must map to where conformity is demonstrated.
Describe the device
Device description and specification, including UDI, variants, and classification, plus the information supplied with the device, meaning labels, Instructions for Use, and packaging.
Assemble design and evidence
Design and manufacturing information, the benefit-risk analysis, risk management documentation, and the product verification and validation data, including the clinical or performance evidence.
Map the GSPR properly
The GSPR checklist cross-references each applicable requirement in Annex I to the specific evidence that satisfies it. Done well it is a precise map a reviewer can follow; done poorly, with generic entries or missing clauses, it is a common cause of findings.
Make it traceable
We build the mapping so each requirement points to real, locatable evidence, and we flag the gaps that need filling before submission rather than after a Notified Body finds them.
Where we fit: we author and assemble the documentation and work alongside your quality and testing functions, which own the underlying validation. We do not run the testing or the QMS audit.
What we prepare
Full technical fileCompilation to MDR or IVDR Annex II and III.
GSPR mappingAnnex I mapping and conformity checklists tied to real evidence.
IFU and labelingInstructions for Use, labeling content, and packaging text.
Benefit-risk and risk managementDocumentation support aligned with ISO 14971.
Device descriptionIntended purpose and classification rationale.
Legacy remediationTechnical file gap analysis and remediation for transitioning devices.
How EvySaif helps
We compile and author the technical documentation so your device reads as a coherent, evidence-backed whole. We build the GSPR mapping to point at locatable evidence, keep claims and evidence in line, and flag gaps before a Notified Body does.
Why EvySaif
EvySaif is one of the best research and medical writing consultancies in India, and it shows in the quality of every deliverable. A technical file fails on incoherence more often than on any single missing study, so we build yours for traceability and consistency, with claims, evidence, and GSPR mapping that line up.
Frequently asked questions
The General Safety and Performance Requirements in Annex I of the MDR and IVDR. Every applicable requirement must be addressed, with the technical file mapping each one to the evidence that demonstrates conformity.
Yes. We prepare IFU and labeling content as part of the technical documentation, aligned with the applicable requirements.
Yes. We perform gap analysis against current MDR or IVDR requirements and remediate documentation for devices transitioning from the old Directives.
Have a different question?
Tell us about your product, market, and timeline, and a clinician on our team will reply with specifics rather than a sales script.
Request a proposalBuilding your technical file?
Tell us about your product and timeline, and we will come back with a scoped proposal for the dossier and strategy work.
Request a proposal