The EU MDR governs how medical devices are placed on the European market. CNC Services guides manufacturers, authorised representatives and importers through the full pathway — from device classification and EUDAMED registration to obtaining a Single Registration Number (SRN), assigning UDI codes, and achieving CE certification.
Actor, UDI and device registration in the EU database
Obtain and manage your Single Registration Number
Basic UDI-DI, UDI-DI and UDI-PI structuring
Technical documentation & conformity assessment
Risk-based classes under Annex VIII of Regulation (EU) 2017/745
Low Risk
Low-risk devices. Generally self-certified, though sterile (Is), measuring (Im) and reusable surgical (Ir) devices need Notified Body involvement for those aspects.
Medium-Low Risk
Medium-low-risk devices requiring Notified Body conformity assessment before CE marking.
Medium-High Risk
Medium-high-risk devices with more stringent Notified Body scrutiny of the technical documentation.
High Risk
Highest-risk devices requiring the most rigorous assessment, including clinical data and, where relevant, a consultation procedure.
The three pillars of MDR traceability — and exactly what CNC Services handles for you
The European Database on Medical Devices is the central IT system underpinning the MDR. It brings transparency to actors, devices, certificates and market surveillance across all Member States.
Your unique economic-operator ID under the MDR. The SRN is issued once your Actor registration is validated by the competent authority, and is required before applying for conformity assessment.
A globally harmonised system that uniquely identifies devices through their distribution and use, improving traceability, recall management and post-market surveillance.
Every UDI is made of two parts — plus the physical carrier on your label
The primary key that groups devices with the same intended purpose, risk class and design. It appears in EUDAMED, on certificates and in the Declaration of Conformity — but not on the label.
The Device Identifier — specific to each device model/version and the access key to the UDI database. Assigned via an official issuing entity.
The Production Identifier — variable data such as lot/batch, serial number, expiry date and manufacturing date.
The physical mark on the label and packaging: machine-readable (AIDC, e.g. barcode/QR) plus human-readable interpretation (HRI).
A systematic path to placing your device on the EU market
We assess your device against MDR requirements and determine its risk class under Annex VIII, defining the correct conformity route.
We register you as an economic operator in EUDAMED and secure your Single Registration Number, including EU Authorised Representative setup for non-EU manufacturers.
We structure your Basic UDI-DI, UDI-DI and UDI-PI, coordinate with an issuing entity, and specify compliant UDI carriers for your labels.
We compile the Annex II & III technical file — GSPR checklist, risk management, clinical evaluation and labelling — ready for assessment.
We manage the Notified Body assessment (Class IIa and above) through to issue of your CE certificate and EU Declaration of Conformity.
We register your UDI and device data in EUDAMED and set up post-market surveillance, PMCF and vigilance processes to keep you compliant.
Key obligations we manage across the EUDAMED modules
Registration of manufacturers, authorised representatives and importers as economic operators in EUDAMED.
Issued by the competent authority after validation; required before conformity assessment applications.
Mandatory EU-based representation for manufacturers established outside the European Union.
The primary device group identifier used in EUDAMED, certificates and the Declaration of Conformity.
Device and production identifiers enabling full traceability from manufacture to point of use.
AIDC + human-readable marks placed on labels, using entities such as GS1, HIBCC, IFA and ICCBBA.
Registration of device data and UDI records in EUDAMED before or at the time of placing on the market.
Reporting of serious incidents and field safety corrective actions to authorities.
Ongoing monitoring of device safety and performance, including post-market clinical follow-up.
Let our MDR experts handle your EUDAMED registration, SRN, UDI codes and CE certification