Written and maintained by CASRAI Editorial Board
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This page describes products and general use; it is not medical advice.
Who this is for: clinic staff, buyers and procurement teams who have been asked for, or handed, a “certificate of conformity” for a medical device and need to know what it is, whether one should exist, and how it differs from the other documents in a supplier file.
What is a certificate of conformity for a medical device?
In the EU system, the document usually meant is the certificate a notified body issues after it assesses a manufacturer’s technical and clinical documentation and quality management system. The Norwegian Medical Products Agency (DMP), applying the EU MDR and IVDR, says that if the documentation meets the requirements, “the notified body shall issue a certificate”, and that the manufacturer must have this certificate to affix the CE marking and place the device on the market (checked 2026-11-01). “Certificate of conformity” is also used loosely for other paperwork, so confirm which document a supplier means before accepting one.
Not every device has one. Whether a notified body certificate exists at all depends on the device’s risk class.
Which devices have a notified body certificate?
| Device category (DMP, applying MDR/IVDR) | Notified body involved? | What a buyer should expect |
|---|---|---|
| Medical devices class IIa, IIb, III; IVD class B, C, D | Yes, before the device can be placed on the market | A notified body certificate, plus the manufacturer’s declaration |
| Class I placed on the market sterile (Is), with a measuring function (Im), or reusable surgical instruments (Ir) | Yes | A notified body certificate, plus the manufacturer’s declaration |
| Custom-made implantable class III devices | Yes | A notified body certificate |
| IVD class A placed on the market sterile | Yes | A notified body certificate |
| Other class I medical devices; other IVD class A | No, assessed by the manufacturer | A manufacturer’s declaration only; there is no notified body certificate to request |
Source: DMP, Conformity assessment involving notified body, updated 14 November 2025; checked 2026-11-01. The third column applies the DMP statements to a buyer’s file; it is an editorial reading, not DMP wording.
Certificate of conformity vs declaration of conformity
They are issued by different parties. The certificate comes from a notified body. The EU declaration of conformity is, in DMP’s words, “the manufacturer’s written declaration that the device meets the requirements of the regulations that apply to the device”, and the CE marking is affixed as a symbol of it (DMP, EU Declaration of Conformity, checked 2026-11-01). For the full contents and signatory rules, see declaration of conformity.
The two documents point at each other. DMP lists what the declaration must contain as a minimum (Annex IV of the MDR/IVDR), including “the name and identification number of the notified body and certificates issued, if applicable”.
Which document proves what
| Document | Issued by | What it attests | Level |
|---|---|---|---|
| Notified body certificate | Notified body | The manufacturer’s documentation and quality management system were assessed and met the requirements (DMP) | Device type and manufacturer |
| EU declaration of conformity | Manufacturer | The manufacturer declares the device meets the applicable regulation (DMP) | Device type |
| CE marking | Affixed by the manufacturer | A symbol of the conformity assessment and declaration (DMP) | Device type |
| Certificate of analysis (CoA) | Producer of the lot | Test results and a release statement for a specific lot (see certificate of analysis) | Lot or batch |
The practical difference: the first three describe the product design and its maker’s system, while a CoA describes one production lot. A device-level certificate does not replace lot-level results, and a CoA does not show that the device type was assessed by a notified body.
CoC vs CoA: device conformity vs lot results
“CoC” can stand for certificate of conformity or certificate of conformance, and no single legal definition applies across all uses. When a supplier offers a “CoC”, ask whether it is the notified body’s certificate or the manufacturer’s declaration. A CoA is different: it reports results for a lot. Our certificate of analysis guide covers its required fields.
Certificate of analysis for medical supplies
For medical supplies, a CoA, where the producer issues one, is lot-specific evidence. It sits beside, not instead of, the conformity documents above.
What to ask a supplier for, and how to cross-check
- Find the device’s risk class in the declaration (Annex IV requires it). Use the table above to see whether a notified body certificate should exist.
- If one should exist, check that the declaration names the notified body and its identification number, and the certificates issued.
- Match the details: the declaration states the manufacturer, device name and intended use (Annex IV); check that the certificate refers to the same manufacturer and device.
- Verify the certificate itself against the public databases: see CE certificate verification for medical devices for the NANDO and EUDAMED steps. A PDF from a supplier is a copy.
- For lot-level needs, request the CoA for the lot you received. The wider paperwork list is in the vendor onboarding documentation checklist.
Common mistakes
- Asking for a notified body certificate for a plain class I device, where DMP says the manufacturer assesses conformity alone.
- Treating the CE marking as the certificate; the mark is a symbol of the assessment and declaration (see what CE marking is).
- Accepting a declaration that names no notified body for a class IIa, IIb or III device.
- Using a CoA for one lot as proof for another lot.
FAQ
What is the difference between a CoC and a CoA?
A conformity document (certificate or declaration) covers a device type against regulatory requirements. A certificate of analysis reports results for a specific lot.
Does every medical device need a notified body certificate?
No. Per DMP, class I devices that are not sterile, measuring or reusable surgical instruments are assessed by the manufacturer without a notified body.
Is a declaration of conformity the same as a certificate?
No. The manufacturer makes the declaration; the notified body issues the certificate. The declaration names the certificate where one applies.
Who designates notified bodies?
Authorities designate them; in Norway DMP does, and designated bodies are listed in the European NANDO database. See notified body designation and audits.
Sources
- Norwegian Medical Products Agency, Conformity assessment involving notified body: https://www.dmp.no/en/medical-devices/development-and-manufacturing/conformity-assessment/conformity-assessment-involving-notified-body (checked 2026-11-01).
- Norwegian Medical Products Agency, EU Declaration of Conformity: https://www.dmp.no/en/medical-devices/development-and-manufacturing/conformity-assessment/declaration-of-conformity (checked 2026-11-01).
- Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), as referenced by DMP.
