Exporting Medical Devices to Europe under the Medical Device Directive
By Marcia B. Haffmans
American medical device manufacturers who want to introduce their products into the European Union ("EU") should appoint an authorized representative based in Europe to ensure compliance with the requirements of the Medical Device Directive (the "Directive")1 . Although the Medical Device Directive went into effect in 1998, U.S. manufacturers are still learning about their obligations related to exporting medical devices to the EU.
Medical devices that fulfill the essential requirements of the Directive and do not endanger the safety and health of persons may be placed on the EU market. Once those requirements are met, a CE 2 mark may be issued for the device, allowing it to be placed on the EU market. CE marking within any member state of the EU permits access to all other member countries, underscoring the importance of the Directive’s objective of the free movement of goods within the single internal market. U.S. manufacturers may wish to enter the EU market for various reasons, one of which may be the perception that CE marking procedures allow for faster product distribution than certification by the FDA.
What is an Authorized Representative?
“Authorized representative” is defined by an amendment to the Directive as any natural or legal person established in the EU who, explicitly designated by the manufacturer, acts and may be addressed by EU authorities instead of the manufacturer with regard to the latter’s obligations under the Directive 3 . The Directive requires that U.S. manufacturers who do not have a registered place of business in any member state of the EU appoint an authorized representative to place a medical device on the EU market. American manufacturers with no offices in the EU must designate a person or entity located in the community to carry out the CE marking procedure and to fulfill other requirements of the Directive. The authorized representative may be a distributor of the manufacturer or an independent, specialized authorized representative firm.
Essential Requirements and Duties of the Authorized Representative
The essential requirements set forth in the Directive lay down the necessary elements for protecting the public interest, taking account of the manufacturer’s intended purpose of the medical device at issue 4 . Thus, the EU system assesses the safety and performance of the device according to its intended purpose of use. The essential requirements are mandatory: only products complying with the essential requirements may be placed on the EU market. Examples of essential requirements relate to technical file maintenance, design and safety standards, risk-assessment and post-market surveillance. Whether a manufacturer appoints its distributor or an independent authorized representative, the manufacturer must make sure that the essential requirements are fulfilled.
The authorized representative must register with the appropriate government authority within the country it is based and add its name to the product documentation (labels/instructions). The authorized representative is furthermore required to respond to inquiries of the European authorities. The manufacturer or its authorized representative must keep the manufacturer's technical file concerning a pertinent product available for the competent authorities for a minimum period of five years after the last product has been manufactured 5. The EU authorities must also be notified if any product has been involved in an incident that has led to a death or serious injury 6.
Risk Categories of Medical Devices
The Directive divides medical devices into four risk category Classes (I, IIa, IIb and III). Class I may represent non-invasive devices, while Classes II and III encompass devices with increased associated risks 7. Manufacturers of Class I devices may typically declare conformity to the requirements without involving a Notified Body, an independent testing laboratory authorized by the EU member state. The Classes with higher associated risks do require involvement of a Notified Body for conformity assessment and verification procedures.
American manufacturers who wish to introduce medical devices into the EU must have a basic understanding of the Medical Device Directive. They should appoint an authorized representative located within the EU to ensure compliance with the regulatory framework. They should also be familiar with the duties of the authorized representative as specified by the applicable EU laws and memorialize those and other legal requirements into a written agreement.
1 Council Directive 93/42/EEC 1993, O.J. (L 169), as amended by 98/79/EEC 1998, O.J. (L 331).
2003 ©Marcia B. Haffmans. All rights reserved. The information herein is not intended as legal advice, and you should not act upon it without professional counsel. For information you may contact Marcia Haffmans at firstname.lastname@example.org.