Annex II & III Technical Documentation · GSPR · CER · PMS · PMCF · PSUR · Notified Body Remediation
EU MDR and IVDR require different pieces of regulatory evidence to tell one consistent story about the device. DnA supports manufacturers when documentation needs to be created, reviewed or brought into alignment for European compliance.
Developing or updating Annex II and Annex III technical documentation
Closing gaps identified during regulatory or notified-body reviews
Preparing GSPR documentation with supporting evidence
Establishing PMS and PMCF documentation for continued compliance
Compile device information, design and manufacturing records, verification and validation evidence into organised technical documentation.
Map applicable safety and performance requirements to standards, risk controls, test evidence, clinical documentation and supporting records.
Structure PMS and PMCF activities to capture relevant information after market entry and keep regulatory documentation current.
A technical file may contain all the expected documents and still have inconsistencies between them. DnA Regulatory Solutions reviews how device claims, risk controls, clinical evidence, testing, labelling and post-market documentation relate to one another, helping manufacturers uncover gaps that may otherwise surface during regulatory review.
Review documentation for missing, outdated or conflicting information
Trace regulatory requirements to the evidence used to demonstrate conformity
Align clinical, risk, validation, labelling and post-market records
Clear Traceability Matters:
A reviewer should be able to follow the evidence from a regulatory requirement to the documents that support it. DnA helps create that connection across the technical file, making the documentation easier to review, maintain and update.
DnA supports Annex II and III technical documentation, GSPR, clinical and performance evidence, PMS, PMCF and related regulatory documentation for medical devices and IVDs.
Yes. DnA can assess existing files for missing, outdated or inconsistent information and support remediation before regulatory or notified-body review.
Applicable requirements can be mapped to standards, risk controls, testing, clinical evidence and other supporting records so conformity evidence is easier to follow.
Strengthen technical documentation, close evidence gaps and keep regulatory records aligned as the device progresses through its lifecycle.