Registration of medical devices/IVDs in EU countries

What and Who must be registered in each EU Member State?

Until the full functionality of the Actor and Product modules in the EUDAMED database is achieved (and possibly beyond!), there remains a necessity for national notification in the individual EU Member State for various economic operators, medical devices, and IVDs in accordance with the national requirements.

These requirements vary significantly depending on:

  • the EU Member State;
  • the type of economic operator (manufacturer, EU authorized representative, importer, distributor, producer of systems and procedure packs);
  • the products (medical devices/IVDs, risk classification, custom-made devices, etc.)

The highly diverse and continually changing notification modalities (databases, fees, formalities) across the 27 EU Member States present additional challenges for economic operators aiming to market their products in compliance with regulations within the EU.

Qualitätsmanagement

We support you in navigating the EU jungle of national requirements.

Together, we assess your individual situation and find the right solution through:

  • consulting
  • answering your questions regarding:
      • national requirements,
      • notification obligations,
      • notification procedures, and/or
  • Partial or full outsourcing to our team for:
      • Database entries
      • Provision or review of notification documents
      • Handling all notification processes with minimal effort on your part

Benefit with our knowledge and many years of experience in these EU Member States:

Italy

Italy

Complex database for MD/IVD (NSIS)

except for custommade devices (special notification process with fees)
Necessary: Access, know-how, specific Italian digital signature

Spain

Spain

Complex databases for MD/IVD (CCPS, RPS)

Necessary: Access, know-how, fees

Portugal

Portugal

Complex database for MD/IVD (SIDM)

Link between manufacturer and distributor registrations necessary
Necessary: Access, know-how, (fees for distributors only)

France

France

Specific formalities, documentation and transmission channels

for notification processes depending on the economic operator and product

Latvia

Latvia

LATMED database or specific formalities and documentation

depending on economic operator and product

Slovakia

Slovakia

Specific formalities, documentation and transmission channels

for notification processes depending on the economic operator and product

Lithuania

Lithuania

Specific formalities, documentation and transmission channels

for notification processes depending on the economic operator and product

Rest of EU on request

Rest of EU on request

Requirements and notification processes depending on the EU country, economic operator and product

Need Support for non-EU Countries?

Our global Consulting Services

Would you like to find out more or do you already have specific questions?

Then we look forward to hearing from you and work together to find the right path through the EU jungle of national requirements. Request a free initial consultation*.
Contact us now