MDR and CE Marking: A Guide to Purchasing Medical Devices
- 5 min reading time
CE marking shows that the manufacturer has declared a medical device to be in conformity with the EU Medical Device Regulation (MDR, Regulation (EU) 2017/745). Buyers should check the CE mark, risk class, the notified body number where applicable, the UDI and the labelling, and document them traceably. This overview does not replace legal advice.
What CE marking means
As a rule, medical devices may only be placed on the market in the European Economic Area with CE marking. Exceptions apply, for example, to custom-made devices and investigational devices. With the CE mark, the manufacturer declares that the product meets the general safety and performance requirements of the MDR and has undergone the prescribed conformity assessment procedure.
An important point: CE marking is not a quality seal and says nothing about quality compared with other products. If a notified body is involved, its four-digit identification number appears next to the CE mark. For class I products without special characteristics, the manufacturer declares conformity itself, in which case this number is absent.
Risk classes under the MDR
The MDR divides medical devices into four classes according to their risk. The class determines how extensive the conformity assessment is and whether a notified body must be involved.
| Class | Examples | Notified body involved? |
|---|---|---|
| I | non-sterile examination gloves, wooden spatulas | no, declaration of conformity by the manufacturer |
| I sterile, with measuring function or reusable surgical (Is, Im, Ir) | sterile compresses, reusable surgical instruments | yes, for sterility, measuring function or reprocessing |
| IIa | disposable hypodermic needles | yes |
| IIb | ventilators | yes |
| III | heart valves | yes |
Transition periods: why MDD products are still on the market
The MDR has applied since 26 May 2021 and replaced the former Medical Device Directive 93/42/EEC (MDD). Nevertheless, many products with a valid certificate under the old directive may still be placed on the market. Regulation (EU) 2023/607 extended the transition periods, depending on the risk class, until the end of 2027 or the end of 2028, provided the manufacturer meets certain conditions, such as an ongoing MDR application with a notified body. At the same time, the former sell-off deadline for products already placed on the market was removed.
For purchasing, this means that a product with an MDD certificate is not automatically non-compliant. It is still worth asking the supplier about the status of the MDR transition, especially for products that are meant to stay in the range for the long term. You can read more about the current deadlines in our article MDR 2026: What buyers need to know.
Who is responsible? Manufacturers, distributors, operators
The MDR distributes obligations among several economic operators. The manufacturer is responsible for conformity, technical documentation and post-market surveillance. Manufacturers outside the EU appoint an EU authorised representative. Before making a product available, distributors must check, among other things, that it bears the CE mark, that an EU declaration of conformity exists, that labelling and instructions for use are included and, where required, that a UDI has been assigned.
Practices, medical care centres and hospitals are involved as operators and users. In Germany, the Medical Devices Operator Ordinance (MPBetreibV) governs, for example, instruction, the inventory register, the medical device logbook and safety and metrological checks for certain devices. These obligations mainly concern active devices rather than consumables.
UDI, EUDAMED and traceability
The Unique Device Identification (UDI) consists of a static part for the device model (UDI-DI) and a variable part for production, for example batch, serial number or expiry date (UDI-PI). It appears on the label as a barcode or Data Matrix code and in plain text. The obligation to apply it was introduced in stages by risk class and now also applies to class I products.
The European database EUDAMED is becoming mandatory step by step. For buyers, the UDI is a practical tool: if you record batch and UDI at goods receipt, you can quickly determine whether affected products are in stock in the event of recalls or field safety corrective actions. In Germany, the BfArM publishes manufacturers' customer information on such measures.
Checklist for purchasing medical devices
- CE marking present, with the notified body number where required.
- Risk class and certificate status known: MDR, or MDD within a transition period.
- EU declaration of conformity requested from the supplier if needed.
- Labelling and instructions for use in the language required in Germany, usually German.
- Manufacturer and, where applicable, EU authorised representative and importer stated on the packaging.
- UDI, batch and expiry date legible and recorded at goods receipt.
- For gloves: classification as a medical device, as personal protective equipment under Regulation (EU) 2016/425, or both, see Medical gloves compared.
- Manufacturer's quality management, for example according to ISO 13485, see ISO 13485: identifying qualified suppliers.
- File documents in an orderly way so that audits and complaints remain traceable.
On ShopMed24, established suppliers offer their products. Details such as manufacturer, item number and packaging unit come from the respective supplier, who also sets its own prices. With a buyer account you order as a practice or facility; our FAQ answer general questions about orders and accounts.
Related categories and guides
- Consumables
- Gloves and masks
- Diagnostics
- MDR 2026: What buyers need to know
- ISO 13485: identifying qualified suppliers
Frequently asked questions
Does every medical device carry CE marking?
As a rule, medical devices may only be placed on the market in the EU with CE marking. Exceptions include custom-made devices and investigational devices.
What is the MDR?
The Medical Device Regulation, Regulation (EU) 2017/745, is the EU regulation for medical devices. It has applied since 26 May 2021 and replaced the former Directive 93/42/EEC.
May I still buy products with an MDD certificate?
Yes, provided the product falls under the extended transition periods and the manufacturer meets the conditions. If in doubt, ask the supplier about the certificate status.
What does the number next to the CE mark mean?
The four-digit number is the identification number of the notified body involved in the conformity assessment. It is absent for class I products without sterility, measuring function or reprocessing.
What do I need the UDI for?
The UDI uniquely identifies the product and batch. It simplifies goods receipt and documentation and helps to find affected products quickly in the event of a recall.
Does this article replace legal advice?
No. It provides a general overview for purchasing. For binding information, please contact specialist lawyers, authorities or your quality management officers.
Consumables and medical devices from established suppliers are available in the Consumables category. If you need a specific product that is not yet listed, send us a product request.
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