The European medical device (MD) market is estimated to be worth around €140 billion. It is the second MD market in the world, covering 27.6% of the world market, behind only the United States.
This should be encouraging to medical device companies that are considering exporting their products to the European Union (EU). What should MD manufacturers think about when doing business in the EU?
Considerations When Shipping Medical Devices to Europe
The first step to shipping medical devices to Europe is to comply with regulatory requirements.
Compliance is determined through the CE mark. It indicates that the manufacturer complied with European standards of safety, health, and environmental protection.
CE marking can be obtained as follows:
1. Classification
Medical devices are divided into four classifications (Class I, Class IIa, Class IIb, and Class III) based on risk and intended use—the higher the risk, the higher the Class.
2. Quality Management System
Medical device manufacturers must have a Quality Management System (QMS) in accordance with Annex II or V of the Medical Devices Directive (MDD). QMS compliance is based on ISO 13485, which specifies requirements for an organization to demonstrate its ability to manufacture medical devices that meet customer and regulatory requirements.
3. Technical Documentation
Technical documentation indicates conformity and must include all prurient details such as device description, manufacturing information, safety requirements, risk management, and more.
4. Authorized Representative
The manufacturer must authorize an EU representative that will be their liaison to the European Ministry of Health.
5. Declaration of Conformity & CE Marking
When conformity assessment is done, the manufacturer will sign the EU Declaration of Conformity. After this, the CE mark can be affixed on the device.
6. Labeling
The EU comprises 31 countries and 23 official languages. Labeling of MDs, instructions for use, and documentation must be done in the Member State’s official language. The translation should comply with national regulatory requirements.
7. Shipping and Import
Before manufacturers ship their products, they must designate an official importer from the EU. The importer is officially the entity that will purchase the medical device from the manufacturer and sell it to local distributors or end-users.
Importers must register with EUDAMED or the European Database on Medical Devices.
8. VAT and Import Duties
The EU implements an average value-added tax (VAT) rate of 21%. However, due to the COVID-19 pandemic, VAT and custom duties are currently suspended in the EU. The waiver will be implemented until June 30, 2022.
When importing goods to Europe, manufacturers must have a VAT number and EORI (trade) number.
There are two options for stocking goods in Europe:
Bonded
Stocking your medical devices in a bonded warehouse means you can defer payment of duty tax and VAT until they are distributed for sale. While it leads to additional stocking expenses, it will reduce your shipping costs.
Non-Bonded
When importing goods into Europe, you must pay the appropriate import rate, unless you request for an article 13 license. In this case, you don’t have to pay the import duties, and get the administrative mandate to process importation.
9. Logistics and Storage
According to Medical Device Regulations (MDR), it is the importer’s responsibility to ensure that logistics—including transportation of medical devices—conform to safety standards and will uphold the quality of the products.
The storage facility should also comply with standards indicated under the MDR.
Medical Devices Business in Europe
Selling and distributing medical devices to the booming European market can contribute to strong revenue growth.
Navigating the compliance requirements is complicated; fortunately, there is thorough documentation on the unified regulations for medical device manufacturers that want to penetrate the EU.
More Information?
GrowthImports provide non-EU medical and in-vitro device manufacturers with independent European-wide importing services compliant with Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) requirements.
Import your medical goods Into Europe with our hassle-free market access Importing service while maintaining flexibility, compliance and Increased quality standards.
With over 30 years of combined experience, GrowthImports is dedicated to ensure the facilitation of a compliant and smooth international MDR/IVDR compliant importing process in the European market.
GrowthMedics is an ISO 13485 market development provider serving worldwide medical device companies with their international sales expansion in European and Middle Eastern Healthcare markets.