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National Registration for Medical Devices & IVDs

Placing a medical device or IVD on the European market requires more than compliance with MDR or IVDR. Although they both apply across the EU, each Member State may impose additional national registration requirements for medical devices and in vitro diagnostic devices (IVDs). This means that to make your product available in specific countries such as Italy, Spain, France, Bulgaria, (Greece), Slovakia, Croatia, Portugal, Romania, Lithuania, and Latvia, a local notification or registration must be performed in certain cases before your product can be placed on the market.

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Ensure Full Market Access with Country-Specific Registration Support

Legal background

While MDR aims to harmonise medical device regulations, national health authorities often require additional pre-market notifications, technical documentation, and language-specific labelling. Obelis strongly recommends that national registrations are performed by your Authorised Representative, not by third-party commercial entities. This keeps you in full control of your product, your market presence, and your long-term strategy.

Failing to comply with country-specific rules can result in:

- Denied market access or delays in product launch.
- Legal penalties and product withdrawal.
- Loss of control over your regulatory documentation if handled by a distributor.
- Risk of re-registration every time you change your distributor.
- Unintended exclusivity agreements that restrict open distribution.

Our services

Obelis: Your Partner for Country-Specific Medical Device Registration

Obelis manages national registration procedures in all countries where additional regulatory steps are required for medical devices and IVDs. As your Authorised Representative, we ensure your products are properly registered and compliant with each country’s specific legislation before market placement. We:

Act as your legally appointed representative for national registrations in:
Italy, Spain, France, Bulgaria, Croatia, Romania, Lithuania, Portugal, Slovakia andLatvia..

Prepare, review, and submit all required documents to local Competent Authorities (e.g. AEMPS, AFSSAPS etc.)

Ensure compliance with language-specific labelling, technical file requirements, and local procedures.

Manage regulatory correspondence and provide official acknowledgements and registration certificates.

Keep you informed of changes in national legislation and renewal obligations.

Guarantee your full control over registrations, no reliance on commercial distributors.

Avoid the regulatory setbacks and take full control of your medical device registrations. Trust Obelis to navigate national registration requirements with unmatched expertise and local insight.

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