National Registration & GMDN code

Looking to market your medical device in the EU Member States? Additional national device registration requirements apply to you!

In the jungle of intricacies and constant change, MDSS provides a full package of services to both EU and non‐EU manufacturers by supporting with national registrations.

The National Registration story:

While MDR has come into force to uniformly and equally apply to all EU Member States, this has not always been the case, especially in the olden time of the MDD. Medical device registration requirements have been the obligation of the EC‐REP to comply with.

The EC‐REP’s registration in the Member State where they are based has been the primary registration of the device in the EU. With this, the non‐EU manufacturer has passed the threshold of placing their devices on the EU market. However, some EU member states have posed additional notification requirements, the so‐called “national registrations” also known as “secondary registrations”.

How was this possible to add registration requirements? We need to take a look at the history of the European legislations. Up until May 2021, medical devices were governed by the Medical Device Directive and directives had to be transposed to national laws of each Member States. The latter had a degree of freedom to either adopt the directive in its current from or to create a much stricter set of rules, including additional notification requirements. Thus, some Member States imposed additional notification requirements to the primary one performed in the EU. Since the date of application of the MDR, the MedTech world has been holding its breath for the implementation announcement of the European database EUADMED. While EUDAMED’s full functionality is still out of reach, some Member States have indeed revoked their additional requirements, such as Croatia, France, among others. Whereas other Member States have kept and some – announced their intentions of keeping their national medical device databases and portals beyond EUADMED’s functionality, such as Italy, Spain.

MDSS provides notification services to meet additional registration requirements, which apply to you, in EU Member States including Italy, Spain, Portugal, Latvia, Greece, Slovakia, and Lithuania, among others. We expertly manage your registration by handling the products notification with the competent authorities in these countries.

While registrations in the mentioned countries might be managed by various entities, it is important to highlight that centralizing registrations with MDSS can lead to time and cost savings. The process of updating registration details with each new business partner can be cumbersome and may result in shipping delays.

If you encounter any additional requirements or want to register in any other country not listed above, let us know and we will find out the requirements for you!

National registration & GMDN Code

GMDN-code research - for efficient medical device registration:

For the National Registration in the Italian, Spanish and Portuguese databases, GMDN codes are required and the codes can be utilized for the European medical device databank EUDAMED.

Additionally, the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom and the Therapeutic Goods Administration (TGA) in Australia also require the use of GMDN codes for medical device registration.

The Global Medical Device Nomenclature (GMDN) is a widely used nomenclature for generic identification of medical devices.

The GMDN system is maintained by the GMDN Agency. Manufacturers and other interested parties can become members of the agency and get access to the GMDN terms. However, for this service the GMDN Agency charges an annual membership fee (for details see the GMDN Agency website).

Finding the right GMDN code for your product can be a daunting and time-consuming task if you’re navigating the process alone.

At MDSS, we simplify this challenge for you. You don’t need to become a member of the GMDN Agency—our experts are here to help you select the most appropriate GMDN code for your medical device. If a suitable code does not exist yet, we can also assist you in applying for a new one.