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
Europe represents one of the world’s most attractive markets for medical device businesses:
- Healthcare expenditure represents approximately 11% of the EU’s GDP.
- By 2027, the European medical device market is projected to surpass $204 billion USD.
- Europe accounts for around 26% of global medical device market share, ranking second only to the United States.
For Chinese manufacturers seeking growth, Europe offers substantial and long-term potential—provided regulatory requirements are met.
Steps Towards Entering 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
Core MDR & IVDR Requirements
The Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) outline the essential safety and performance requirements all devices must meet.
Devices that must fully comply include:
Under MDR (as of May 26, 2021)
- Class I devices
- Custom-made devices
- Devices containing non-viable human-derived tissues or cells
- Software classified as a medical device
- Devices newly introduced to the market (not previously CE-marked under MDD)
- Procedure packs and systems
- Class I reusable surgical instruments (rsi)
Under IVDR (as of May 26, 2022)
- Class A devices
- Newly introduced IVD products that did not exist under IVDD
Understanding MDR Legacy Devices
To avoid shortages and market disruptions, MDR introduced a legacy period for certain devices. This applies to:
- Devices certified under the former MDD (Classes I, Im, IIa, IIb, III)
- Up-classified devices requiring CE Certification under MDR
- Class I reusable surgical instruments now requiring notified body involvement
This transitional framework offers manufacturers additional time to align with MDR while maintaining market continuity.
How Obelis Supports Chinese Manufacturers
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.
FAQ
- Why is Europe an attractive market for medical device manufacturers?
Europe has a large consumer base and advanced healthcare infrastructure, with healthcare expenditure representing around 11% of GDP. By 2027, the European medical device market is projected to surpass $204 billion USD, accounting for 26% of global market share, making it the second-largest market after the US.
- What are the first steps for entering the EU medical device market?
Key steps include:
- Determining if your device requires CE Marking
- Identifying the applicable legislation (MDR or IVDR)
- Completing any necessary third-party conformity assessments
- Appointing an EU-based Authorised Representative if your company is outside the EU
- Registering your product and gaining access to EU, EEA, EFTA, and other markets
- What are the main requirements under MDR and IVDR?
MDR (Medical Device Regulation) applies to:
- Class I devices
- Custom-made devices
- Devices containing non-viable human-derived tissues or cells
- Medical software
- New devices not previously CE-marked under MDD
- Procedure packs, systems, and Class I reusable surgical instruments
IVDR (In Vitro Diagnostic Regulation) applies to:
- Class A IVD devices
- Newly introduced IVD products not previously regulated under IVDD
- What are MDR legacy devices?
MDR includes a legacy period to ensure market continuity. This applies to:
- Devices certified under the former MDD (Classes I, Im, IIa, IIb, III)
- Up-classified devices now requiring CE Certification under MDR
- Class I reusable surgical instruments requiring notified body involvement
The legacy period helps manufacturers align with MDR without disrupting market supply.
- Do non-EU manufacturers need an Authorised Representative?
Yes. Non-EU manufacturers must appoint an EU-based Authorised Representative (EC REP) to place medical devices on the EU market legally.
- How can Obelis support Chinese manufacturers entering Europe?
Obelis provides comprehensive services including:
- Acting as a Professional Authorised Representative
- Device and actor registration
- Regulatory updates via MDlaw Information Platform
- Assistance with Notified Body applications
- Quality Management System compliance training
- Guidance for technical file compilation
- Issuing Free Sales Certificates (FSC)
- Facilitating market access in EU, UK, and Switzerland
- Why is it important to comply with MDR and IVDR?
Compliance ensures your devices are legally marketable in the EU, reduces regulatory risk, and helps you maintain consumer safety standards, giving your products credibility in a highly regulated market.
- How can I get started with Obelis?
Contact our team to discuss your medical device portfolio and receive guidance on EU market entry, compliance strategies, and regulatory support.
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.