Medical Device Market Access in Europe: A Practical Case Study on German Company Registration and CE Certification

Challenges Faced

Clients must complete CE certification, establish a legal entity in Germany, and build an after-sales service system compliant with EU requirements. Key challenges include: complex CE certification processes requiring MDR (Medical Device Regulation) compliance and long approval timelines; German company registration mandates a local director and registered address; establishing an after-sales service and quality management system aligned with EU MDR standards; and managing VAT registration and filings across all EU member states.

Solutions

Tiger International helped clients develop a comprehensive strategy to enter the European market. For company registration, we registered GmbH (limited liability companies) for our clients in Germany and provided local director services and a registered address. We assisted with all necessary procedures, including drafting articles of association, commercial registration, and tax registration. Additionally, we supported clients in opening corporate bank accounts at German commercial banks. Regarding CE certification, we coordinated with notified bodies in Germany to help clients complete MDR compliance assessments. We prepared technical documentation, including product descriptions, design drawings, risk assessment reports, and clinical evaluation reports. Notably, we assisted clients in establishing quality management systems compliant with ISO 13485 requirements. In terms of market operations, we helped set up warehousing and after-sales service centers in Germany to ensure rapid response to market demands. We also supported the recruitment of local sales and service teams and established customer support systems in both German and English. For compliance support, we provide ongoing regulatory updates, including MDR implementation progress and VAT policy changes across various countries. We assisted clients with VAT registration in EU member states to ensure compliant sales practices.

Achieve Results

• The product has successfully obtained CE certification and complies with the EU MDR requirements.
• Enter the EU 15 country market, including major nations such as Germany, France, the UK, and Italy.
• Annual sales exceeded €10 million, accounting for 25% of total revenue.
• Established a comprehensive European operations system, including warehousing, after-sales service, and customer support.
• Qualify for German health insurance reimbursement and inclusion in public hospital procurement catalogs.