With its vast consumer base and robust healthcare infrastructure, Europe presents an enticing opportunity for businesses seeking to expand their global footprint. However, entering this market requires a comprehensive understanding of regulations and compliance standards. Here’s everything you need to know about selling medical devices in Europe as a Chinese manufacturer:
Medical Device Market: Key Facts
The European medical device market is substantial, with approximately 11% of the GDP dedicated to healthcare spending. By 2027, the market value is projected to exceed $204 billion USD, making it the second-largest market globally after the United States. Europe accounts for roughly 26% of the global medical device market share, offering significant growth opportunities for manufacturers.
Steps Towards the EU Market
Entering the EU market requires adherence to stringent regulatory requirements. Key steps include:
- Understand if the product needs the CE Marking
- Identify the applicable legislation
- Undergo any necessary third-party conformity assessment
- Appoint an Authorised Representative if non-EU MF
- Access the EU, EEA, EFTA, and other markets
Main MDR & IVDR Requirements
The Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) outline essential requirements for medical devices in the EU. Starting from May 26, 2021 (MDR) and May 26, 2022 (IVDR), certain devices must fully comply with the regulations, including:
- Class I devices under MDR
- Custom-made devices
- Medical devices utilizing non-viable human-derived tissues/cells
- Software products meeting medical device criteria
- New products not previously marked under MDD/IVDD
- Procedure kits and systems
- Class A devices under IVDR
- MDR Legacy Devices
To facilitate a smooth transition and prevent market disruptions, the MDR allows for a “legacy period” for certain devices. This grace period applies to devices certified under the Medical Device Directive (MDD) Classes I, Im, IIa, IIb, and III, as well as up-classified medical devices requiring CE Certification under MDR, including Class I reusable surgical instruments (rsi).
How Obelis Can Help You?
At Obelis Group, we offer a range of services to streamline your entry into the European medical device market:
- Professional Authorised Representative & consultancy services
- Actor registration and device registration
- Regulatory updates (MDlaw Information Platform)
- Notified body application
- Quality Management System compliance course
- Technical file compilation guidance
- Free Sales Certificates (FSC)
- Access to EU, UK, and CH market
Navigating the European medical device market as a Chinese manufacturer can be challenging, but with Obelis Group as your partner, you can navigate regulatory hurdles with confidence and capitalize on the vast opportunities available in Europe.
Get in touch with us today to learn more about how Obelis can assist you.
Sandra Ferretti
Obelis Group CCO
15.04.2024
The information contained on obelis.net is presented for general information purposes only, without obligation and it has been compiled with the utmost care to ensure it remains up to date. Nevertheless, Obelis Group cannot be held liable for the accuracy and completeness of the information published. Any reliance placed on such information is therefore strictly at the User’s risk.