EC certificates for medical devices

Question 01

Is “EC certificate” a valid term? #

It depends on the regulatory context.

Under the former European medical-device directives, several official certificate titles contained “EC,” including EC type-examination certificates and EC design-examination certificates. The term therefore has a genuine regulatory history.

Under the current Medical Device Regulation (EU) 2017/745, however, “EC certificate” is not the official name of one particular document. The MDR defines several certificates issued by Notified Bodies, including:

• EU quality management system certificates
• EU technical documentation assessment certificates
• EU type-examination certificates
• EU product verification certificates
• EU quality assurance certificates

In everyday regulatory work, “EC certificate” is still widely used as an informal umbrella term for these certificates. It is concise and generally understood, but it does not tell you which conformity-assessment procedure was followed or what the certificate actually covers.

Question 02

What does an EC certificate actually confirm? #

An EC certificate confirms that a Notified Body has completed a particular part of the conformity assessment and found that the assessed elements comply with the applicable MDR requirements.

The scope depends on the certificate type. One certificate may cover the manufacturer’s quality management system. Another may cover the technical documentation for a particular product design. A certificate may instead relate to type examination, product verification or production quality assurance.

This distinction matters. An EC certificate is not a general statement that everything connected with the product has been approved. It confirms only the conformity-assessment elements identified in its scope.

Question 03

Is an EC certificate required to sell a medical device in the EU? #

Sometimes, but not always.

A certificate issued by a Notified Body is normally required when the applicable conformity-assessment procedure requires Notified Body involvement. This is generally the case for:

Ordinary Class I devices that are not sterile, do not have a measuring function and are not reusable surgical instruments generally do not require Notified Body certification.

These devices are subject to manufacturer self-declaration. “Self-declaration” does not mean that regulatory requirements can be ignored. The manufacturer must still establish an appropriate QMS, prepare technical documentation, perform a clinical evaluation, implement risk management and PMS, demonstrate GSPR conformity, issue the EU Declaration of Conformity and affix the CE marking.

The applicable routes are established in Article 52 of the MDR ↗. Special rules apply to custom-made, investigational and certain other devices.

Question 05

How does an EC certificate relate to CE marking? #

A Notified Body certificate is often a necessary step in obtaining CE marking, but the certificate and the CE marking are not the same thing.

The Notified Body assesses the elements assigned to it under the selected conformity-assessment route. If the assessment is successful, it issues the applicable certificate or certificates.

The certificate does not authorize the manufacturer to ignore the remaining MDR obligations. Nor does the Notified Body assume the manufacturer’s responsibility for the product.

The CE marking represents the manufacturer’s declaration that the device complies with the applicable requirements. The Notified Body certificate supports that declaration where third-party involvement is required. See Articles 19 and 20 of the MDR ↗.

Question 06

Who issues EC certificates? #

Certificates under the MDR are issued by Notified Bodies. A Notified Body is an organization designated by a national authority to perform specified conformity-assessment activities. It may assess only products and procedures falling within its designated scope.

Not every Notified Body can assess every medical device. Before applying, the manufacturer should verify that the organization is designated for:

• The MDR
• The relevant product type
• The applicable MDA or MDN codes
• Relevant MDS or MDT codes
• The intended conformity-assessment procedure

The European Commission’s NANDO database ↗ can be used to check the current designation and scope of a Notified Body.

Question 07

Can one medical device require more than one certificate? #

Yes. There is no universal certificate covering every conformity-assessment route.

Depending on the route, the manufacturer may receive a combination of certificates. One may cover the quality management system, while another covers the technical documentation for a particular product design. A certificate may even state that another certificate is required before the covered device can be placed on the market.

Question 08

How long is an EC certificate valid? #

Under Article 56 of the MDR, a certificate is valid for the period stated on it, which may not exceed five years. The manufacturer may apply for renewal for further periods of up to five years following reassessment under the applicable procedure.

There is no general MDR rule limiting certificates for high-risk devices to one year. A five-year expiry date also does not mean that nothing happens during those five years.

Continued validity depends on ongoing conformity, successful surveillance, implementation of the approved QMS, appropriate PMS and vigilance, proper change control and compliance with certificate conditions. The maximum validity and renewal rules are set out in Article 56 of the MDR ↗.

Question 09

What can happen if the manufacturer no longer complies? #

The MDR uses more precise language than “invalidation.” If the manufacturer no longer meets the applicable requirements, the Notified Body may restrict, suspend or withdraw the certificate.

The Notified Body should consider proportionality and may allow the manufacturer an appropriate period to implement corrective action.

• Serious or persistent QMS nonconformities
• Failure to implement adequate corrective action
• Failure to maintain the technical documentation
• Failure to meet surveillance obligations
• Unreported substantial changes
• Changes implemented without required approval
• Failure to maintain MDR conformity
• Failure to comply with certificate conditions

A new or revised standard does not automatically make a certificate invalid. The manufacturer must assess the change, determine its regulatory impact and update the compliance strategy where necessary.

Loss or restriction of a Notified Body’s designation also does not necessarily make every certificate it issued immediately invalid. The responsible authority assesses the effect and determines the required action.

Question 10

Must the Notified Body be informed about every product or QMS change? #

Not necessarily every change, but relevant changes must be evaluated through a controlled process.

Under Annex IX, the manufacturer must inform the Notified Body about planned substantial changes to the approved QMS or the covered device range.

The Notified Body may conclude that the change is covered by existing certification, requires more documentation, requires an audit or testing, needs a certificate supplement, or triggers a new conformity assessment.

Question 11

Will changing a contract manufacturer affect the certificate? #

It can, but a certificate update is not automatic in every case.

Changing a contract manufacturer may affect the approved QMS, manufacturing controls, product specifications, validation status, supplier-control arrangements, assessed sites or continued product conformity. The legal manufacturer remains responsible even when manufacturing is outsourced.

1. 01Qualify the new contract manufacturer
2. 02Assess regulatory and product risks
3. 03Update supplier-control documentation
4. 04Review manufacturing and validation requirements
5. 05Update the QMS and technical documentation
6. 06Determine whether the change is substantial
7. 07Notify the Notified Body where required
8. 08Obtain approval before implementation where applicable

The Notified Body may review the documentation, perform an additional audit or inspect the new site. If the change is substantial, approval may take the form of a supplement to the QMS certificate. A newly issued certificate should not be assumed necessary before the change and its impact are evaluated.

Question 12

What should a manufacturer check when receiving a certificate? #

Do not stop at the certificate title. Check the complete scope.

A certificate is useful only when its scope matches the manufacturer, product, conformity-assessment procedure and activities actually performed.