Before CE marking
Before CE marking: the first technical file under MDR
CE marking a medical device under MDR means proving conformity with the general safety and performance requirements and documenting that proof in a technical file your notified body can audit. Nitro cOS tells engineers which documents that file requires for the work in front of them, before the work starts rather than during review.
What the regulation requires
The Medical Device Regulation (EU 2017/745) requires a manufacturer to demonstrate conformity with the general safety and performance requirements in Annex I and to compile technical documentation according to Annexes II and III. For most devices above Class I, a notified body assesses that documentation and the quality management system before a CE certificate is issued.
The technical file is not one document. It is a set of linked records: device description and intended purpose, design and manufacturing information, risk management under ISO 14971, verification and validation evidence, clinical evaluation under Article 61 and Annex XIV, labelling and instructions for use, and a post-market surveillance plan. Each has to be consistent with the others, and the whole set has to be kept current for the life of the device.
Most of these requirements are discovered late. The engineer building a feature rarely knows which requirements it touches or which records it will generate, so the gap shows up at design review or notified body audit, when it is most expensive to close.
How Nitro helps
Nitro cOS connects to the QMS and SharePoint you already use and reads your existing documents, templates and specifications. When an engineer describes what they are building, Nitro returns the list of documentation that work requires, with references to the relevant MDR articles, annexes and harmonised standards.
Drafts are written from your own earlier documents, product specs and policies, with citations back to the source, so they use your terminology and your templates rather than generic text. The dependency map shows how each new document relates to the risk file, the clinical evaluation and the rest of the technical file.
Every draft is reviewed and approved by a named person before it enters your quality system. Nitro does not replace your QMS or change your processes; it sits on top of them.
Questions
- Does Nitro CE mark the device for us?
- No. CE marking is the manufacturer's declaration and, for most classes, requires a notified body. Nitro helps your team know which documentation is required and produce it from your own material. Conformity assessment stays with you and your notified body.
- Which parts of the technical file does Nitro cover?
- Nitro works with the documents in your QMS and SharePoint: design inputs and outputs, risk management, verification and validation, clinical evaluation, labelling and post-market surveillance. It tells engineers which of these their work affects and drafts the ones that need writing.
- Does Nitro work with our existing templates?
- Yes. Nitro reads your templates and earlier approved documents and drafts in the same structure. Nothing is migrated or moved, and a named reviewer approves every change.