CE 93/42/EEC explained for medical device import compliance
What CE 93/42/EEC means for today’s shipments
CE 93/42/EEC refers to CE conformity under Council Directive 93/42/EEC, the former EU Medical Devices Directive, often shortened to MDD. When a supplier sends a certificate or declaration showing “93/42/EEC”, the document was usually issued under the old medical device framework, not under the current EU Medical Device Regulation, Regulation (EU) 2017/745. That distinction matters for import compliance. A 93/42/EEC document may still be relevant for some “legacy devices” during EU transition periods, but it is not enough by itself to prove that a medical device can be newly placed on the EU market today.
For importers, distributors, procurement teams and cross-border traders, the issue is not simply whether the CE mark appears on the product. The key question is whether the device, manufacturer, certificate, declaration of conformity and transition evidence still fit the applicable MDR rules. You can also explore more in Compliance.
This article is part of our Compliance coverage for international trade teams that review supplier documents before shipments move.
From MDD to MDR in plain English
Council Directive 93/42/EEC of 14 June 1993 was the long-standing EU legal framework for general medical devices. Under that system, devices meeting the applicable essential requirements could bear the CE marking and be placed on the EU market. Depending on the risk class and conformity assessment route, a notified body might issue a certificate, or the manufacturer might rely on a declaration of conformity for certain lower-risk devices.
The MDD framework has been replaced by Regulation (EU) 2017/745, commonly called the MDR. The MDR entered into force in 2017 and began applying from 26 May 2021 after a one-year postponement. It repealed Directive 93/42/EEC, but the repeal did not immediately remove every MDD certificate from commercial use. Article 120 of the MDR created transitional rules for certain devices that had already been certified or declared under the old framework.
That is why “CE 93/42/EEC” can be confusing in trade documents. It may appear in a valid legacy device file, on an expired certificate, in an outdated supplier template, or in a document that does not match the actual product. The label alone does not answer the compliance question.
Why a 93/42/EEC certificate is not the same as current MDR approval
The MDR changed the regulatory environment in several important ways. It strengthened requirements for clinical evaluation, post-market surveillance, vigilance, traceability, economic operator responsibilities and notified body oversight. It also introduced explicit duties for importers and distributors. In practical terms, the MDR is not just a renamed version of the MDD.
A medical device that is newly entering the EU market generally needs to meet MDR requirements unless it qualifies for a transitional provision. If a supplier says a device is “CE approved under 93/42/EEC”, importers should treat that as the start of due diligence, not the end of it.
Three document types are especially important:
- EU or EC declaration of conformity: The manufacturer’s legal declaration identifying the product, manufacturer, applicable legislation and conformity route.
- Notified body certificate: Required for many higher-risk devices and certain sterile or measuring devices, but valid only for the devices and scope listed on the certificate.
- Transition evidence: For legacy devices, evidence that the manufacturer meets the MDR transitional conditions, such as timely application to a notified body and a written agreement where required.
An MDD certificate can be commercially useful only if the device falls within the allowed legacy framework and the relevant conditions continue to be met. If the product has changed significantly in design or intended purpose, or if the certificate was withdrawn, the legacy route may not be available.
When a 93/42/EEC legacy device may still be accepted
Regulation (EU) 2023/607 extended the MDR transition periods for certain legacy medical devices. This was not a blanket extension for every product with old paperwork. It is conditional and risk-class dependent.
For devices with certificates issued under Directive 93/42/EEC or the Active Implantable Medical Devices Directive, the transition may run until 31 December 2027 for Class III devices and certain Class IIb implantable devices. For other Class IIb devices, Class IIa devices, and relevant Class I devices that were sterile or had a measuring function, the transition may run until 31 December 2028. Certain devices that were self-declared under the MDD before 26 May 2021 but require notified body involvement under the MDR may also fall under the extended route until 31 December 2028.
The transition is available only if the statutory conditions are met. In simplified commercial terms, the device must continue to comply with the old rules, must not have significant changes in design or intended purpose, must not present an unacceptable health or safety risk, and the manufacturer must have taken the required MDR transition steps by the relevant deadlines. For many devices, that meant having a compliant quality management system by 26 May 2024, lodging a formal MDR conformity assessment application by 26 May 2024, and signing a written agreement with a notified body by 26 September 2024.
| Document scenario | What it may mean | Importer action |
|---|---|---|
| Valid-looking MDD notified body certificate | The device may be a legacy device, but the certificate alone does not prove transition eligibility. | Request the declaration of conformity, certificate scope, expiry history, notified body status and transition evidence. |
| Expired MDD certificate | It may still be treated as valid only in limited cases under MDR transition rules. | Check whether the legal conditions for extended validity were met before the relevant cut-off dates. |
| MDD declaration for Class I device | Some Class I devices had self-declared MDD conformity, but many now need MDR documentation. | Confirm whether the device was up-classified or now requires notified body involvement. |
| Supplier sends only a CE logo image | A CE logo is not proof of conformity by itself. | Request the complete regulatory file documents that correspond to the exact model being purchased. |
Practical checks before relying on CE 93/42/EEC documents
Import compliance teams should review 93/42/EEC documents with the same discipline they apply to customs classification, certificates of origin or restricted-party screening. A certificate may be genuine but irrelevant to the actual product, model, manufacturer or shipment date.
Match the product and scope
Start by matching the commercial product name, model number, Basic UDI-DI where available, intended purpose, accessories and variants. A certificate for a product family does not automatically cover every similar-looking item sold by the supplier. If the device has been rebranded, modified or bundled into a kit, check whether the certificate still covers the configuration being imported.
Check the manufacturer and authorised representative
The legal manufacturer on the declaration of conformity should match the manufacturer responsible for placing the device on the market. If the manufacturer is outside the EU, an authorised representative should be identified where required. Importers should be cautious when the trading company named on a proforma invoice is not the legal manufacturer named in the regulatory documents.
Verify the notified body reference
For certificates involving a notified body, check the notified body name, identification number, certificate number, scope, issue date, expiry date, amendments and any suspension or withdrawal information available from official sources. The CE marking on the product label should be consistent with whether notified body involvement was required. See also: Customs.
Request transition documentation
For a legacy MDD device still being supplied into the EU, ask the manufacturer for a written explanation of the MDR transition basis. This may include a manufacturer declaration confirming that Article 120 conditions are met, evidence of timely MDR application, evidence of a written agreement with a notified body, and confirmation that there have been no significant changes in design or intended purpose.
Review importer obligations under the MDR
The MDR gives importers their own obligations. Importers are expected to place only compliant devices on the Union market, verify that the device bears CE marking, confirm that the declaration of conformity has been drawn up, check that the manufacturer and authorised representative information is present, and keep copies of relevant declarations and certificates where applicable. These duties are not satisfied by filing a supplier’s certificate without review.
Common trade risks linked to old MDD paperwork
Old MDD paperwork creates several recurring risks in import transactions. The first is timing: a supplier may present a certificate that was valid years ago but no longer supports placing the device on the market. The second is scope: a certificate may cover one sterile dressing size but not another, or one software version but not the current version being shipped. The third is regulatory mismatch: the product may be a medical device in the EU but marketed under a different category in another jurisdiction.
Another risk is overbroad use of the phrase “CE approved”. CE marking is a manufacturer’s claim of conformity under applicable EU legislation; it is not a single approval issued by a central EU agency for all product types. In medical devices, notified bodies play a key role for many classes, but their certificate must be read together with the manufacturer’s declaration and the applicable legislation.
Importers should also watch for non-medical products that carry CE marking under other EU legislation, such as machinery, electromagnetic compatibility, personal protective equipment or low-voltage equipment. A CE mark under another framework does not show compliance with medical device rules. Conversely, a medical device file under 93/42/EEC should not be used to support a product that is no longer within the same intended medical purpose.
How to handle supplier claims in commercial negotiations
When a supplier states that a device has “CE 93/42/EEC”, the best response is a precise document request rather than a general objection. Ask for the declaration of conformity, the notified body certificate if applicable, label and instructions for use, authorised representative details, importer information requirements, risk class under the MDD and MDR, and a written statement explaining whether the device is supplied under MDR certification or under a legacy transition route.
If the supplier cannot provide transition evidence for a legacy device, the buyer should avoid assuming that old paperwork is sufficient. That does not automatically mean the product is non-compliant, but it means the compliance basis has not been demonstrated. For regulated medical devices, uncertainty can delay customs clearance, procurement approval, hospital onboarding and post-market responsibility assignments.
For cross-border traders, the commercial contract should also reflect document responsibilities. Purchase orders can require the supplier to provide current regulatory documents before shipment, notify the buyer of certificate suspension or withdrawal, confirm that there have been no significant changes affecting legacy status, and provide updated documents when MDR certification is obtained. These clauses are not substitutes for legal compliance, but they help reduce avoidable trade risk.
Frequently asked questions
Is CE 93/42/EEC still valid?
Not as a general route for new medical devices. Directive 93/42/EEC has been replaced by the MDR. Some legacy devices may still be placed on the EU market during extended transition periods if all legal conditions are met. The answer depends on the device class, certificate status, dates, manufacturer actions and whether there have been significant changes.
Can an importer accept an expired 93/42/EEC certificate?
Only with great caution. Some expired MDD certificates may be treated as valid under MDR transition rules if specific conditions are satisfied. The importer should request documented evidence of the transition basis and should not rely on the expired certificate by itself.
Does a CE mark prove the product is compliant?
No. The CE mark is important, but importers need the supporting documents. For medical devices, that typically means the declaration of conformity, any required notified body certificate, labelling and instructions, manufacturer and authorised representative details, and transition evidence where the device relies on MDD legacy status.
What is the difference between MDD and MDR?
MDD refers to the former Medical Devices Directive 93/42/EEC. MDR refers to Regulation (EU) 2017/745, the current EU medical device framework. The MDR introduced broader and more detailed requirements for clinical evidence, post-market surveillance, traceability, economic operators and notified body oversight.
What should buyers do if a supplier only provides a certificate photo?
Request complete, legible documents and match them to the exact product model and shipment. A certificate photo may be incomplete, outdated or outside the product scope. For regulated devices, buyers should not release orders solely on the basis of a CE logo or a cropped certificate image.
