Build a medical device compliance record (MDR and IVDR)

What applies today

The MDR and IVDR require device identification through the UDI system and registration in EUDAMED, conformity assessment by a notified body for most device classes, and published summaries of safety and clinical performance for implantable and class III devices (MDR) and of safety and performance for class C and D in vitro diagnostics (IVDR).

What the pack checks

DPP Shield validates a passport against the bundled EU-MDR pack, which is a draft readiness pack, plus the ESPR core checks every category shares: identifiers, the economic operator, the data carrier, substances of concern and passport availability. Required findings block publication; findings to check are flagged for review. Each finding in the console names its rule and source.

Required - blocks publication

• The Basic UDI-DI and the UDI-DI.
• The manufacturer's single registration number (SRN) from EUDAMED.
• A notified body for devices above class I (and for class I sterile, measuring or reusable surgical instruments) and for IVD classes B, C and D.
• The notified body certificate, still valid.
• A summary of safety and clinical performance for class III and implantable devices, or of safety and performance for IVD classes C and D.
• SVHC information above 0.1 % w/w, with the SCIP number.

What it flags for review

These do not block publication, but resolve each one before the passport goes public.

Check - flagged for review

• Manufacturer identity.

Evidence to collect

Attach these in Documents and link them to the passport, or request them from suppliers.

Typical evidence

• Notified body certificates with their validity dates.
• EUDAMED registrations (SRN, Basic UDI-DI, UDI-DI).
• The summary of safety and (clinical) performance.
• Electronic instructions for use.
• The justification and labelling for CMR or endocrine-disrupting substances above 0.1 %.

Build the passport step by step

1. Create the product with the category Medical devices - in Products, by CSV import or from a connected store.
2. Open DPPs and choose Create passport: the form shows the medical devices fields together with the shared blocks (identifiers, manufacturer, materials, substances of concern, data carrier and passport availability).
3. Choose the regulation (MDR or IVDR) and the risk class first; they decide which checks apply.
4. Record whether the device is sterile, single-use or implantable.
5. Keep clinical evaluation, post-market surveillance and manufacturing records restricted.
6. Attach the evidence in Documents and send supplier requests for anything you cannot support yourself.
7. Run Validate EU and work through the findings until no required finding is left.
8. Preview the public page, redact commercially sensitive fields, then publish.

Before you publish

Because the bundled packs are drafts, publishing needs an accountable override approved by a second owner or administrator until your platform operator activates a legally reviewed pack. The readiness score is not a legal assessment: confirm the obligations that apply to your product with your compliance adviser.

Certificate dates matter: set the expiry on the certificate document in the vault so expiry warnings reach you before it lapses.