REGULATORY COMPLIANCE
Check the European medical device status of our products in seconds. Search for a product, see whether it is certified under the MDR or the MDD, and download or request its certificate and Declaration of Conformity.
Search by product name or SKU and choose your product from the list.
Information on this page is provided for guidance. The binding documents are the certificate issued by the Notified Body and the EU Declaration of Conformity issued by the manufacturer. Please always check the validity date.
All products with documented MDR or MDD status at a glance.
The Medical Device Directive was the European framework for medical devices for many years. Devices certified under the MDD are called “legacy devices”. It has now been replaced by the MDR.
The Medical Device Regulation has applied since 26 May 2021. It sets stricter rules for clinical evidence, product safety, traceability (UDI) and post-market surveillance, and is directly binding in all EU countries.
Under Regulation (EU) 2023/607, devices with a valid MDD certificate may stay on the market until 31 Dec 2027 (class III and implantable IIb) or 31 Dec 2028 (other IIb, IIa and class I sterile or measuring devices), if the manufacturer meets the conditions.
Both are EU rules for medical devices. The MDD (93/42/EEC) was a directive, which each country put into national law. The MDR (EU) 2017/745 is a regulation that applies directly in all EU countries, with stricter requirements for clinical data, safety, traceability and monitoring after the product is on the market.
Yes. Legacy devices with a valid MDD certificate can still be placed on the EU market during the transition period, if the manufacturer meets the conditions of Regulation (EU) 2023/607. Products already supplied can continue to be used.
The EU Declaration of Conformity (DoC) is a document in which the manufacturer declares that a medical device meets the European requirements. Every CE-marked medical device has one. For class I devices (non-sterile, without measuring function) the manufacturer declares conformity without a Notified Body.
The four-digit number is the identification number of the Notified Body that assessed the product. You find it on devices of class Is, Im, Ir, IIa, IIb and III. Class I devices without a sterile or measuring function carry the CE mark without a number.
Search for the product above and press “Request documents”, or use the general request form below. Our team will send you the latest certificate and Declaration of Conformity we have for the product.
For tenders, audits or product registrations, our team can prepare a full documentation package for you.
