EU MDR · conformity assessment · CE · EUDAMED
How to “register” a medical device in the EU
The short answer is that you do not register it through a conventional government pre-market approval procedure.
In the EU, a manufacturer does not submit one registration dossier to a regulator and wait for permission to sell. It demonstrates compliance with the MDR, undergoes Notified Body assessment where required, signs the EU declaration of conformity, affixes the CE marking and separately enters the required information in EUDAMED.
Separate the concepts ↓- Registration dossier
- Review by a government authority
- Permission to sell
- Evidence of MDR conformity
- Notified Body involvement where required
- Manufacturer’s declaration and CE marking
- Registration data in EUDAMED
The short answer
The EU does not issue one medical device registration certificate
The right to affix the CE marking follows from a completed conformity assessment procedure, not from a decision by one EU regulator to admit the product to the market.
The manufacturer is responsible for qualification and classification, its quality management system, technical documentation, clinical evaluation, risk management, post-market surveillance and compliance with every applicable MDR requirement.
For most Class IIa, IIb and III devices and the special Class I categories, a Notified Body joins the procedure. It issues a certificate within the scope of its assessment. The manufacturer, not the Notified Body, then draws up the EU declaration of conformity and affixes the CE marking.
Instead of “the device is registered and approved in the EU”, say “the manufacturer has ensured MDR compliance, completed the applicable conformity assessment, drawn up the EU declaration of conformity, affixed the CE marking and registered the required data in EUDAMED”.
Four different concepts
Registration, certification and CE marking are not interchangeable
The confusion begins when several independent actions are compressed into the word “registration”. Each has a different actor, output and legal meaning.
Conformity assessment
The procedure used to demonstrate fulfilment of the MDR. The route depends on the device class and characteristics.
- Result
- Documented conformity
- Does not mean
- Entry in a register
Notified Body certificate
Issued when the selected procedure requires Notified Body involvement. Its meaning is limited to the certificate’s scope.
- Result
- MDR certificate
- Does not mean
- Government authorization
Declaration and CE marking
The manufacturer draws up the EU declaration of conformity and affixes CE after completing the applicable procedure.
- Result
- Access to the EU market
- Does not mean
- A mark granted by a regulator
EUDAMED registration
The system holds data on economic operators, UDI and devices, certificates and other parts of the device lifecycle.
- Result
- Records and identifiers
- Does not mean
- A conformity review
Technical documentation
EU declaration of conformity
CE marking on the device
Certificate where required
Assessment reports
Economic operator SRN
UDI/Device record
Certificate data
The real route
What to do instead of looking for a “registration procedure”
The route cannot be reduced to uploading a dossier. Several workstreams run in parallel, but every relevant control point must be closed before the device is placed on the market.
The steps below describe the standard route for a serially manufactured CE-marked device. Custom-made devices, investigational devices, health-institution devices under Article 5(5), and systems or procedure packs follow special provisions and require a separate analysis.
- 01QUALIFY
Identify the applicable legislation
Fix the intended purpose and determine whether the product is a medical device under the MDR, an IVD under the IVDR, an accessory, an Annex XVI product or a non-medical product.
- 02CLASSIFY
Justify the class and route
Apply Annex VIII, determine whether the device is Class I, IIa, IIb or III, and check for the special Is, Im or Ir categories.
- 03EU ROLES
Build the regulatory infrastructure
Appoint the PRRC. A manufacturer outside the EU also needs an authorised representative. Identify importers and define the duties of other supply-chain actors.
- 04ACTOR REGISTRATION
Obtain the EUDAMED SRN
The manufacturer, authorised representative and importer complete the applicable steps in the Actor registration module. The SRN identifies an organisation, not a device.
- 05SYSTEM AND EVIDENCE
Create the QMS and technical documentation
The Annex II and III documentation connects the device description, GSPR, risk management, verification and validation, clinical evaluation, labelling and PMS.
- 06IDENTIFICATION
Assign the Basic UDI-DI and UDI
The manufacturer obtains access to an authorised issuing entity’s system and assigns identifiers under the applicable rules. The Basic UDI-DI groups a device model or family and is not placed on the label.
- 07CONFORMITY ASSESSMENT
Complete the correct procedure
Ordinary Class I normally follows self-assessment. A Notified Body participates for Is, Im, Ir, IIa, IIb and III devices to the extent required by the MDR and selected annex.
- 08LEGAL COMPLETION
Draw up the declaration and affix CE
After successful assessment, the manufacturer signs the EU declaration of conformity. Where a Notified Body participated in the applicable procedure, its identification number accompanies the CE marking.
- 09BEFORE THE MARKET
Register device data and activate PMS
Before placing the device on the market, the manufacturer enters the required UDI and device data in EUDAMED, ensures correct labelling and instructions, and then performs PMS, vigilance and change control throughout the lifecycle.
Economic operator registration and assignment of an SRN occur relatively early. Registration of the UDI and data for the specific device is completed before the device is placed on the market. “EUDAMED registration” is therefore not one procedure performed at a single point in the project.
Three concrete routes
There is no identical “registration” for every device
The examples show what changes with the device category. EUDAMED remains a registration system in all three cases, but it is not the authority that admits the product to the market.
A mass-produced non-sterile orthotic insole
The assumptions are contact only with intact skin, no measuring function and no custom-made status.
- The manufacturer justifies Class I
- It prepares the QMS and technical documentation
- It self-assesses conformity
- It signs the declaration and affixes CE
- It registers the actor and device data in EUDAMED
Normally not required
A sterile single-use examination spatula
The assumptions are transient use through the oral cavity, no connection to an active device and supply in sterile condition.
- The manufacturer justifies Class I and the Is category
- It documents sterilisation and maintenance of sterility
- A Notified Body assesses the sterility aspects
- The manufacturer signs the declaration and affixes CE with the body’s number
- The required data are entered in EUDAMED
Only to the extent established for Class Is
An active diagnostic device classified as IIa
The assumptions are an intended purpose and Rule 10 analysis leading to Class IIa without conditions that raise the class.
- The manufacturer documents qualification and classification
- It selects a Notified Body with the appropriate designation scope
- It undergoes QMS and required technical documentation assessment
- After certification, it signs the declaration and affixes CE
- The device and certificate data are reflected in EUDAMED
Required
What changes is the conformity assessment procedure, not the presence or absence of a regulator’s marketing authorization. Even an ordinary Class I manufacturer must comply with the MDR and can be inspected by a competent authority after the device is placed on the market.
May
2026
What changed in 2026
Registration became mandatory, but it did not become market approval
On this date, the first four EUDAMED modules became mandatory, including Actor registration and UDI/Device registration.
This makes “registration” legally accurate when it means entering information in EUDAMED. The system still does not perform the clinical evaluation, approve the technical documentation or grant the manufacturer the right to affix CE.
Economic operators
Records for manufacturers, authorised representatives and importers, including the SRN.
UDI and devices
Basic UDI-DI, UDI-DI and the required data set for devices placed on the market.
Bodies and certificates
Information about Notified Bodies and records of certificates issued under the MDR and IVDR.
Market surveillance
Tools used by competent authorities and the European Commission for surveillance activities.
An SRN or device record in EUDAMED does not by itself demonstrate MDR conformity. A reviewer still needs to see the applicable certificate, EU declaration of conformity, correct CE marking and consistent device information.
Precise language
How to describe the device without implying regulatory approval
Precision matters in contracts, websites, distributor communications and investor materials.
“The device is registered in the EU”
“The device complies with the MDR, bears the CE marking and its required data are registered in EUDAMED”
“The EU approved the device”
“The manufacturer completed the applicable MDR conformity assessment procedure”
“The Notified Body issued the CE mark”
“The Notified Body issued a certificate, after which the manufacturer drew up the declaration and affixed CE”
“The SRN is the device registration number”
“The SRN identifies the economic operator in EUDAMED”
“The Basic UDI-DI is the approval number”
“The Basic UDI-DI identifies a device model or family in regulatory documentation and EUDAMED”
In English, the confusion usually involves registration, certification and approval. German discussions often merge Registrierung, Zertifizierung and Zulassung. Under the MDR, these terms describe different actions and should not be treated as synonyms.
Practical questions
What people usually mean by “registration”
Open a question to separate conformity assessment from an administrative record.
Does an EU regulator issue permission to sell a medical device?+
For the standard route to market, the MDR does not establish one EU authority that reviews a registration dossier and grants a marketing authorization. The manufacturer ensures compliance with the MDR, completes the applicable conformity assessment, draws up the EU declaration of conformity and affixes the CE marking. Competent authorities perform market surveillance rather than issue a routine pre-market authorization.
Is a Notified Body certificate a marketing authorization?+
No. The certificate confirms that the Notified Body assessed the quality management system, technical documentation or device type identified in the certificate under the selected procedure. It allows the manufacturer to complete its own conformity process, but it does not replace the EU declaration of conformity and is not a registration certificate.
Must the device now be registered in EUDAMED?+
Yes. The Actor registration and UDI/Device registration modules became mandatory on 28 May 2026. The manufacturer must complete the applicable actor and device-data obligations before placing the device on the market. Entering data in EUDAMED is not a safety assessment, product approval or substitute for conformity assessment.
Can a Class I manufacturer proceed without a Notified Body?+
An ordinary non-sterile Class I device without a measuring function and without reusable surgical instrument status can generally follow self-assessment. For Is, Im and Ir devices, a Notified Body assesses only the relevant aspects of sterility, the measuring function or reuse.
What does an SRN prove?+
The SRN is the single registration number of an economic operator in EUDAMED. It identifies a manufacturer, authorised representative or importer. It neither demonstrates the conformity of a particular device nor serves as a device registration number.
What must a manufacturer outside the EU do?+
Before placing a device on the market, the manufacturer must designate one authorised representative in the EU for at least all devices of the same generic device group and define the mandate in writing. The manufacturer and representative register as economic operators in EUDAMED. Appointing a representative does not transfer the manufacturer’s responsibility for compliance.
When can the device be sold in the EU?+
After all applicable MDR requirements have been met, the required conformity assessment has been completed, the necessary Notified Body certificate has been issued, the manufacturer has drawn up the EU declaration of conformity and affixed the CE marking, and the mandatory EUDAMED actions have been completed before placing the device on the market. The labelling, instructions, post-market surveillance system and necessary supply-chain roles must also be in place.
Official sources
Check the route against the MDR and the current EUDAMED status
For a particular device, use the current consolidated MDR and check any applicable transitional or special provisions.
Regulation (EU) 2017/745
Articles 10, 11, 15, 19, 20, 29, 31 and 52 and Annexes II, III, IX, X and XI
EUDAMED overview
Mandatory modules and implementation status from 28 May 2026
UDI/Device registration
European Commission information on the UDI/Device data set
Notified Bodies
The role of independent conformity assessment before market placement
Start with the correct route
Need to place a specific device on the EU market?
MDRC can qualify and classify the product, define the conformity assessment procedure, and plan the technical documentation, EUDAMED, UDI and Notified Body work.
