EU market access · MDR and IVDR
CE certificate and EC certificate for medical devices
“CE certificate” is widely used, but it can conceal three different things: the CE mark, the manufacturer’s EU declaration of conformity and a certificate issued by a Notified Body.
Which documents you need depends on whether the product is governed by the MDR or IVDR, its risk class, its characteristics and the selected conformity assessment route. A certificate is not a substitute for the rest of the compliance system.
The conformity route connects the evidence. It does not turn these elements into the same document.
Start with the terminology
One informal phrase, three different regulatory elements
There is no single document formally called the “CE certificate” that every medical-device manufacturer must obtain. The phrase is often used as shorthand, but the legal documents and their issuers are different.
A marking
CE marking
The CE mark is affixed to a compliant device before it is placed on the EU market. Where a Notified Body is involved, its four-digit identification number normally follows the mark.
The manufacturer after completing conformity assessment
A manufacturer document
EU declaration of conformity
The declaration identifies the device and states that the applicable regulatory requirements have been fulfilled. By signing it, the manufacturer assumes responsibility for conformity.
The manufacturer
Third-party evidence
Notified Body certificate
A designated Notified Body issues a certificate after completing the applicable assessment. The formal title depends on the regulation and conformity assessment route.
A Notified Body designated for the relevant scope
The classification decides
Who needs a Notified Body certificate?
Every manufacturer must complete conformity assessment. The difference is whether the manufacturer can complete it without a Notified Body or whether independent assessment and certification are required.
Regulation (EU) 2017/745
Medical devices
Class I
Devices that are not sterile, do not have a measuring function and are not reusable surgical instruments generally do not require a Notified Body certificate.
Class Is, Im and Ir
A Notified Body is involved only in the sterile, metrological or reusable-instrument aspects specified by MDR Article 52(7).
Class IIa, IIb and III
A Notified Body must perform the applicable conformity assessment and issue the certificate or certificates linked to the selected route.
Regulation (EU) 2017/746
In vitro diagnostic devices
Class A non-sterile
The manufacturer generally completes conformity assessment and issues the EU declaration of conformity without a Notified Body certificate.
Class A sterile
A Notified Body is involved only in the aspects relating to establishing, securing and maintaining sterile conditions.
Class B, C and D
A Notified Body performs the applicable assessment. Higher classes may also require additional technical documentation, laboratory or expert-review procedures.
These are the general routes for devices placed on the market. Custom-made devices, investigational devices, performance-study devices, in-house devices and transitional legacy devices require separate analysis.
The complete pathway
A certificate is one output of conformity assessment
Certification sits inside a wider sequence. Starting with a certificate request before the product and regulatory route are defined usually creates rework rather than market access.
Qualify and classify
Confirm the product status, intended purpose and risk class.
Select the route
Choose the applicable MDR or IVDR conformity assessment procedure.
Build the evidence
Prepare the QMS, technical documentation and clinical or performance evidence.
Complete external assessment
Engage a properly designated Notified Body where the route requires it.
Issue the declaration
Draw up and sign the EU declaration of conformity for the covered device.
Affix the CE mark
Apply the marking and Notified Body number where applicable.
A connected evidence set, not a standalone certificate
The certificate must remain aligned with the approved QMS, technical documentation, device scope, EU declaration of conformity, registration data, labelling and post-market controls.
Read the actual title
Notified Body certificates are route-specific
The MDR and IVDR do not reduce conformity assessment to one generic certificate. The exact document depends on the annex route and what the Notified Body assessed.
EU quality management system certificate
Evidence that the Notified Body approved the quality management system for the stated regulatory scope and device groups.
EU technical documentation assessment certificate
Evidence of a successful product-specific technical documentation assessment where the applicable route requires it.
EU type-examination certificate
Evidence that a representative type conforms to the applicable regulatory requirements under the Annex X route.
Production assurance or product verification certificate
Evidence linked to the Annex XI conformity route and the controls applied to production or product verification.
Why “EC certificate” is still heard
The terminology changed, but legacy certificates still exist
Certificate titles under the former medical-device directives used “EC” terminology, including EC design-examination and EC type-examination certificates. The MDR and IVDR generally use “EU” in the formal titles of certificates issued under the new regulations.
A document called an EC certificate is therefore not automatically false or invalid. It may be a genuine certificate issued under a former directive. Its relevance depends on the applicable transitional provisions, certificate validity, device status and continued fulfilment of the conditions for a legacy device.
Certificate due diligence
Check the certificate, the issuer and the scope
A professional-looking PDF is not enough. Confirm that the issuing body was designated for the relevant legislation and scope, and that the certificate actually covers the manufacturer and devices being supplied.
- Issuing body
- Name and four-digit Notified Body number
- Legal manufacturer
- Exact entity name and registered address
- Regulatory basis
- MDR or IVDR and the applicable annex route
- Covered scope
- Device groups, models, Basic UDI-DI or certificate schedule
- Certificate status
- Issue date, expiry date, supplements and restrictions
Verify the Notified Body in NANDO
Match the four-digit number and confirm that the body is designated under the MDR or IVDR for the procedures and device technologies concerned.
Open NANDOVerify the certificate with its issuer
Use the Notified Body’s certificate database or contact the body directly. Check the certificate number, current status, covered sites, device scope and any supplements.
Match the certificate to the supplied device
Confirm that model names, Basic UDI-DI data, intended purpose, classification and manufacturer details align across the certificate, declaration, label and technical documentation.
“CE certificate” with no identifiable issuing body
Notified Body number that does not match NANDO
Certificate scope that does not cover the supplied device
Expired, suspended or withdrawn certificate presented as current
What the certificate cannot do
Certification does not freeze compliance in time
A valid certificate records a conformity assessment decision for a defined scope. It does not remove the manufacturer’s continuing obligations or automatically approve every future product change.
Technical documentation must remain current.
Significant changes may require prior Notified Body approval.
Surveillance audits and post-market obligations continue.
The manufacturer remains responsible for product conformity.
Primary sources
Check the route against the official text
The correct outcome depends on the product and the complete regulatory route. Use the current consolidated legislation and the official designation data for the selected Notified Body.
Frequently asked questions
Before relying on a certificate
These answers address the common terminology and route questions. The conclusion for a specific product still depends on its qualification, classification and conformity assessment strategy.
Is there an official CE certificate for medical devices?
CE is a conformity marking, not the formal name of one universal certificate. The manufacturer issues an EU declaration of conformity, and a Notified Body issues route-specific certificates where independent assessment is required.
Do all medical devices require a Notified Body certificate?
No. Under the MDR, most class I devices that are not sterile, do not have a measuring function and are not reusable surgical instruments can be self-declared. Class Is, Im and Ir devices require limited Notified Body involvement. Class IIa, IIb and III devices require Notified Body conformity assessment.
Do all IVDs require a Notified Body certificate?
No. Under the IVDR, class A non-sterile IVDs can generally be self-declared. Class A sterile devices require limited Notified Body involvement, while class B, C and D devices require a Notified Body conformity assessment.
What is an EC certificate?
Formal certificate titles under the former medical-device directives used EC terminology. Certificates issued under the MDR and IVDR generally use EU terminology. Always check the legal basis, annex route, validity and covered devices.
Is an ISO 13485 certificate enough for CE marking?
No. ISO 13485 certification does not by itself demonstrate conformity with the MDR or IVDR. It does not replace the applicable regulatory conformity assessment, technical documentation, EU declaration of conformity or CE marking steps.
How can a medical-device certificate be checked?
Check the Notified Body and its designation scope in NANDO. Then verify the certificate number, manufacturer, covered products, validity dates, annex route, supplements and current status with the issuing body or the applicable EU certificate system.
Define the route before the audit
Know which certificate your device actually needs
MDRC can confirm the regulatory status and class, map the applicable conformity assessment procedure, identify the required certificate set and prepare the evidence interfaces for Notified Body review.
Review your certification routeThis page provides general regulatory information and does not replace a product-specific classification or conformity assessment review.