Actor registration
SRN and account setup
EU Login, actor registration request, Single Registration Number, user access and Authorised Representative mandate links.
EU MDR & IVDR · EUDAMED · UDI
Get your devices into EUDAMED right the first time.
We handle actor registration, UDI assignment and device registration for medical device manufacturers in India and around the world. You send us your product list. We send back registered devices and a complete record of what was submitted.
Fixed fee, priced per device
Bulk XML upload for large catalogues
NDA before any data is shared
Who we work with
Built for manufacturers without a dedicated EUDAMED team
India
Indian exporters
CE-marked manufacturers in Ahmedabad, Hyderabad, Bengaluru, Chennai, Delhi NCR, AMTZ and beyond who need EUDAMED done without hiring a full RA department. Billing in INR with GST invoices.
Worldwide
Non-EU manufacturers
Companies in the UK, US, Turkey, the Middle East and Asia selling into the EU. We work with your Authorised Representative and fit your time zone for calls. Billing in EUR or USD.
Partners
Consultancies & EU reps
Outsource EUDAMED data work to us under your own brand. You keep the client relationship. We do the data preparation and uploads.
Services
Everything between a CE certificate and a registered device
Take one service or the full package. Each is quoted at a fixed price before work starts.
UDI assignment
Basic UDI-DI and UDI-DI plan
GS1 or HIBCC numbering plan, Basic UDI-DI grouping by intended purpose and risk class, check digits verified.
Device registration
EUDAMED data entry
Every mandatory attribute prepared, checked against your technical file and certificates, then submitted.
Bulk upload
XML for large catalogues
Hundreds or thousands of variants (lenses, sizes, kits) built as validated XML and uploaded in batches instead of one record at a time.
Label review
UDI carrier check
Data Matrix or linear barcode, human-readable text and placement checked against MDR Annex VI and GS1 rules.
Maintenance
Annual upkeep
New variants, data changes, certificate renewals and the record updates that follow, on an annual retainer.
How it works
Six steps, one point of contact
Kick-off & NDA
A short call to understand your portfolio, then an NDA and a fixed quote.
Data collection
You fill in our device data template. We go through the gaps with you, field by field.
Actor & SRN
If you are not yet registered, we prepare the actor registration and follow it through to your SRN.
UDI mapping
Basic UDI-DIs and UDI-DIs assigned and checked against certificates, labels and the technical file.
Upload
Manual entry for small portfolios, validated XML for large ones. Every record is checked after submission.
Handover
A register of every submitted record with its status, ready for your notified body or internal audit.
Pricing
Priced per device, so the fee fits the size of your portfolio
The per-record price falls as volume grows. A company with 30 variants pays a small-company price.
| Item | Price |
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Indicative prices. GST is added for Indian clients. GS1 membership and Authorised Representative fees are paid directly by you and are not part of our fee.
Before we start
What you need to have ready
Most delays come from missing data, not from EUDAMED itself. Gather these and registration moves quickly.
- CE certificate(s)Notified body name, number and certificate references, where applicable.
- EU Declaration of ConformityThe current signed version for each device family.
- Device and variant listModel names, catalogue numbers, sizes or powers, pack quantities.
- GS1 company prefixOr HIBCC labeller code. We can guide you through GS1 India membership.
- Authorised RepresentativeName, address and SRN of your EU rep, for non-EU manufacturers.
- Labels and IFUCurrent artwork, so the registered data matches what is on the box.
- ClassificationMDR or IVDR class and rule, sterile, single-use, measuring, implantable.
- Nomenclature codesEMDN codes for each device. We can propose them if you don't have them.
FAQ
Common questions
Is EUDAMED registration mandatory?
Yes. Under the EU MDR and IVDR, manufacturers must register as actors and register their devices and UDI data in EUDAMED. The European Commission is making the modules mandatory in stages, and devices already on the market have their own transition deadlines. We will tell you which deadlines apply to your portfolio.
Do you need access to our EUDAMED account?
Your local actor administrator gives us a user role under your organisation in EUDAMED. You stay the owner of the account and can remove our access at any time.
We have thousands of variants. Is that a problem?
No. Large catalogues are where XML bulk upload helps most. We build and validate the files, upload them in batches and give you a record-by-record status report.
Do you handle IVDR devices too?
Yes. The registration process is the same for IVDR devices. Some data attributes are different, and our data template covers them.
How is our data kept confidential?
We sign an NDA before you share any files. Your data is used only for your registration and is returned or deleted when the project ends.
How long does it take?
Once your data is complete, a small portfolio usually takes one to two weeks. Actor registration depends on review by the competent authority, so we start it first.
About
A regulatory specialist, not a call centre
UDIBridge is run by Pardeep Sheoran, a regulatory affairs professional with hands-on experience in CE marking under the EU MDR, technical documentation, and UDI and EUDAMED registration. You deal with the person doing the work from start to finish.