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FOURTH ANNUAL REPORT OF THE MEDICAL DEVICES ANNEX TO THE U.S./EC MUTUAL RECOGNITION AGREEMENT (MRA)
Issued December 1, 2002

INTRODUCTION

Article 7 of the Medical Device Annex to the U.S./EC Mutual Recognition Agreement (MRA) requires the Commission for the European Communities (CEC) and the government of the United States (U.S.) to prepare annual progress reports describing the confidence building activities undertaken during each year of the transition period. This is the FOURTH progress report, and has been prepared jointly by the U.S. Food and Drug Administration (FDA), the National Institute of Standards and Technology (NIST) and the CEC addressing the implementation of the Medical Devices Annex. It includes background on the MRA and a chronology of accomplishments. This report covers activities from December 1, 2001 to December 1, 2002.

BACKGROUND ON THE U.S./EC MUTUAL RECOGNITION AGREEMENT: THE MEDICAL DEVICES ANNEX

On June 20, 1997, the U.S. and the Commission for the European Communities (CEC) concluded negotiation of the MRA. The MRA covers a variety of product sectors including telecommunications equipment, electromagnetic compatibility, electrical safety, recreational craft, pharmaceutical products, and medical devices. The aim of this agreement is to facilitate transatlantic trade while reducing costs for compliance with regulatory requirements.

On May 18, 1998, representatives of the U.S. and the CEC signed the MRA, marking the start of implementation. On October 30, 1998, the Parties exchanged letters inaugurating the transition period. This agreement became effective December 1, 1998. The Medical Device Annex to the MRA became effective on December 7, 1998, the effective date of the FDA final rule. The effective date initiated a three year transition period during which time both sides engaged in confidence building activities.

After the three year transition period, the agreement was to become operational for conformity assessment bodies (CABs) that successfully completed confidence building activities. However, neither party was prepared to list any CABs as of December 2001. Listing a substantial number of CABs on each side is a prerequisite for starting the operational period for an Annex. The Joint Committee, which meets periodically to review progress of the MRA and all of its annexes, met on November 30, 2001. At that meeting the Joint Committee extended the transition period for the Medical Device Annex for 24 months.

The MRA consists of a framework agreement and individual sectoral annexes. The framework agreement covers the general aspects of implementing the agreement as well as requirements governing CABs, such as listing, suspension and withdrawal.

The Medical Device Annex covers the exchange of quality systems evaluation reports for all medical devices and premarket evaluation reports for selected low to medium risk devices. A European CAB can conduct quality system inspections for all classes of devices and 510(k) evaluations for selected devices based on FDA requirements. Similarly, a U.S. CAB can conduct quality system audits for all classes of devices and type-testing and product evaluations for selected devices based on EC requirements. In addition, an alert system will be set up during the transition period and maintained thereafter, by which the Parties will notify each other when there is an immediate danger to public health. As part of that system, each Party shall notify the other Party of any confirmed problem reports, corrective actions, or recalls.

CHRONOLOGY OF ACCOMPLISHMENTS IN CY 2002 TOWARDS THE IMPLEMENTATION OF THE MEDICAL DEVICE ANNEX TO THE U.S./EC MRA

December 3-5, 2001: An FDA representative and Department of Commerce representatives held several meetings in Brussels, Belgium, with European Commission (EC) staff, European Union (EU) competent authorities, EU Conformity Assessment Bodies (CABs) and European and U.S. industry representatives to discuss implementation of the MRA.

January 11, 2002: FDA notified the Designating Authority (DA) in the United Kingdom that they had verified the DA’s determination that SGS Yarsley met FDA criteria for Conformity Assessment Bodies under the Medical Device Annex of the MRA.

March 14, 2002: FDA and CEC held the fourteenth "Stakeholder Meeting" as an audioconference

March 26 & 28, 2002: An FDA representative addressed the Medical Device Annex of the MRA at industry seminars on FDA device regulations in Edmonton and Vancouver, Canada.

June 3-7, 2002: FDA sponsored training on FDA’s Quality System Requirements for Design Control and Process Validation. The courses were conducted by the Association for the Advancement of Medical Instrumentation (AAMI) and took place in London, United Kingdom. An auditor for a European Union (EU) CAB and two EU CA representatives attended the courses.

July 29, 2002: FDA notified the Designated Authority in Germany that they had verified the DA’s determination that TÜV Product Service met FDA criteria for Conformity Assessment Bodies under the Medical Device Annex of the MRA.

September 20, 2002: Three FDA representatives met in Brussels, Belgium, with an EC staff member and competent authority representatives from Germany, the Netherlands, France and the United Kingdom to discuss EC expectations and qualification requirements for U.S. CABs.

October 9, 2002: FDA and European Commission staff addressed the status of the MRA at the RAPS annual meeting in Washington, D.C. The title of the session was “Status and Politics of US/EC MRA Sectoral Annex on Medical Devices”.

October 22, 2002: FDA and CEC held the fifteenth "Stakeholder Meeting" as an audioconference

November, 2002: FDA requested additional information regarding scope of designation, legal entity, personnel qualifications, and CAB management from the U.S. CABs.

December 1, 2001 – December 1, 2002: FDA conducted six (6) joint quality system audits of EU medical device manufacturers with designated EU CAB auditors. Two independent inspections were conducted by EU CAB SGS Yarsley.

Updated JUN-12-2003

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