National Registration & GMDN code

Looking to market your medical device in the EU Member States? Additional national device registrations may 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 Registrations 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.

We currently provide notification services with the EU Member State Competent Authorities in the following countries, where additional registration requirements may apply: Italy, Spain, Portugal, Latvia, Greece, Slovakia, Croatia, Lithuania, and other countries.

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

If you would like to register your device in a country not listed above let us know  and we will find out the requirements for it!

National registration & GMDN Code

GMDN-code research - for efficient medical device registration:

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

For example the Italian National Registration and Spanish National Registration databases require GMDN codes and the codes can be utilized for the European medical device databank EUDAMED.

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). Also, the research of an applicable code for your product might prove a time-consuming task if you are left alone with it.

MDSS can help you with selecting the appropriate GMDN code, without you needing to become a member of the GMDN Agency. We also offer to assist you with applying for a new GMDN code, if no suitable code does exist yet.

Have MDSS assist you with the choice of an adequate GMDN code.