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MRA Documents

Guidance Documents

Guidance for Staff, Industry, and Third Parties:  Third Party Programs under the Sectoral Annex on Medical Devices
These draft documents have been prepared jointly by the FDA and the Commission for the European Communities (CEC) and are intended to serve as guidance for all interested parties participating in confidence building activities under the medical device annex to the MRA. While these documents reflect the latest EU edits, they have not been accepted by the FDA. FDA is requesting comments on these documents and plans to provide its comments and any relevant stakeholder comments to the CEC. Comments are due 30 days after the date of publish in the Federal Register.
DRAFT Guidance for Staff, Industry and U.S./EU CABs; Implementation Plan for the MRA between the EU and the USA: Confidence Building Program: Overview, Medical Device Annex, Version 7 June 29, 2000
DRAFT Guidance for Staff, Industry and U.S./EU CABs; Implementation Plan for the MRA between the EU and the USA: Confidence Building Program: Procedures, Medical Device Annex, Version 7 June 29, 2000

Minutes

• Minutes from the Thirteenth US/EU MRA Medical Device Annex Stakeholders Teleconference (November 7, 2001)
• Minutes from Twelfth US/EU MRA Medical Device Annex Stakeholders Teleconference (July 12, 2001)
• Minutes from Eleventh US/EU MRA Medical Device Annex Stakeholders Teleconference (April 5, 2001)
• MINUTES - Tenth US/EU MRA Medical Devices Annex Stakeholders Teleconference, January 18, 2001
• Minutes from Eighth US/EU MRA Medical Devices Annex Stakeholders Teleconference (July 18, 2000)
• MINUTES - US/EU MRA Conference Call with Stakeholders, February 28, 2000
• Report on the first Joint Sectoral Committee meeting held on the 26th October 1999 by videoconference between Washington and Brussels.
• Meeting Minutes for the June 27, 1999 Medical Device MRA Stakeholders Meeting
• March 19, 1999 Minutes of the MRA Stakeholders Videoconference

Annual Reports

• First Annual Report of the Medical Devices Annex to the U.S./EU Mutual Recognition Agreement [PDF]
• Second Annual Report of the Medical Devices Annex to the U.S./EC Mutual Recognition Agreement [PDF]
• Third Annual Report of the Medical Devices Annex to the U.S./EC Mutual Recognition Agreement (2001)
• Fourth Annual Report of the Medical Devices Annex to the U.S./EC Mutual Recognition Agreement (2002)
• Fifth Annual Report of the Medical Devices Annex to the U.S./EC Mutual Recognition Agreement (2003)

Other Documents

• On January 6, 1999, FDA published a document on its Home Page on the World Wide Web that is entitled "Guidance for Staff, Industry and Third Parties: Third Party Programs under the Sectoral Annex on Medical Devices to the Agreement on Mutual Recognition Between the United States of America and the European Community; Availability." [PDF] On July 2, 1998 FDA had published a draft of this guidance for comment (63 FR 36240). This guidance covers the designation process for Conformity Assessment Bodies (CABs) and is intended to assist interested persons in preparing their applications. (See 10. below concerning FDA's Accredited Persons Program.)
• FDA has completed its rulemaking to implement the United States-European Union Mutual Recognition Agreement (MRA) Federal Register of April 10, 1998 (63 FR 17744); the proposed rule was published in the Federal Register of November 6, 1998 (63 FR 60122) [Text] or [PDF]. December 1, 1998 was the start of the transitional period for confidence building under the MRA; FDA implementation began on December 7, 1998, 30 days after the publication of the final rule.
• FDA now has explicit authority to recognize voluntary consensus standards for devices due to a FDAMA amendment to section 514(c) of the FFDCA (21 U.S.C. 360d(c)). FDA has now recognized nearly 400 device standards (see, for example, the Federal Register of February 25, 1998 (63 FR 9561). FDA published an update to its initial list of standards on October 16, 1998 (63 FR 55617) [Text] or [PDF], and will publish updates annually.
• Information to be Considered to be Nominated as a European Conformity Assessment Body (CAB) for Conducting Surveillance/Post-Market and Initial/Pre-Approval Quality System (GMP) Audits [PDF]
• Information to be Submitted to FDA by Prospective Third Parties Seeking FDA Recognition for Review of Selected 510(k)s: A Checklist [PDF]

Updated July 8, 2004

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