Our Solutions for Medical Products (Class 1 and 2)
Market Medical Products Safely and Successfully in Europe
Medical products of Class 1 and 2 are subject to the strict MDR (Medical Device Regulation) with extensive documentation and certification obligations. From technical documentation to clinical assessment to EUDAMED registration – the requirements are highly complex and strictly monitored. One mistake can lead to immediate sales bans, product recalls, or existence-threatening fines.
Whether you import, manufacture, or distribute medical products in Europe: We ensure that your products meet all MDR requirements and patients can be safely treated – quickly, reliably, and cost-efficiently.
Are you affected? Find out in 30 seconds:
What is your role with medical products?
Importer: You bring medical products from third countries into Europe
Manufacturer: You produce medical products or have them manufactured under your name
Distributor: You sell medical products for the first time in Europe or under a private label
If any of these roles apply to you, you are fully legally responsible for MDR conformity!
You're probably familiar with these compliance challenges
Typical problems with medical products:
Technical documentation is outdated or MDR-non-compliant
Clinical assessment is missing or does not meet MDR requirements
UDI system (Unique Device Identification) is not implemented
EUDAMED registration was not carried out
Authorized representatives are missing for third-country products
Post-Market Surveillance System is not established
CE marking does not comply with the MDR
Notified bodies were not properly involved
The risk: Immediate sales bans, million-euro fines, product recalls and existence-threatening liability claims.
This is how we make your medical product compliance simple and safe
Our MDR expertise for your success:
With in-depth expertise in MDR and many years of experience in the medical products sector, we know all critical requirements for Class 1 and 2 products. We systematically guide you through the entire compliance process and ensure legally secure MDR-compliant solutions.
Our promise:
Complete MDR compliance testing for Class 1 and 2
Clear recommendations for action that limit risks
Support with implementation of necessary tests or laboratory tests
Cost-efficient strategies for your product class
Network with MDR-specialized compliance experts
Long-term support for product developments and changes
Your advantage: You focus on innovation and patient benefit – we take care of the compliance complexity.
Book your free initial consultation now and save €249!
