NIST Responsibility under the Medical Devices sector of the US-EU MRA
Revised April 2002

Qualification Criteria for U.S. CABs

Under this sector of the MRA, NIST has a supporting role for FDA who is the Designating Authority for U.S. CABs. NIST identifies prospective candidates, reviews their credentials, and recommends qualified candidates to FDA for nomination to the European Commission. The minimum requirements to be a CAB under this sector of the MRA are as follows:

1. The candidate must be based in the United States
2. The candidate must be accredited for Quality System Registration (QSR) for compliance with ISO/IEC Guide 62 plus EU requirements for the Medical Devices by an accreditor acceptable to NIST. The successful candidate shall have the qualified auditors to perform quality systems registration and inspection in accordance with EU requirements. The candidate may subcontract testing portion of its work but must be capable to monitor the performance of this work.
3. The candidate's staff must be thoroughly familiar with the Council Directive(s), its annex(es) of interest, and the product groups of interest.
4. The candidate must be willing to perform audits with participation from NIST/FDA, and EU experts as observers.
5. Those candidates seeking scope for Type Examination and/or EC Verification (product certification) must be accredited for compliance with ISO/IEC Guide 65 plus EU requirements for medical devices for the product group(s) of interest.

CAB Operation Under the MRA

Under the medical devices sector of the MRA, a manufacturer will contract with an U.S. CAB as well as with an EU Notified Body having appropriate accredited scopes. The manufacturer may select the EU Notified Body in consultation with the U.S. CAB. The later will perform the Quality System Registration function in accordance with the EU requirements; prepare all documents necessary for CE marking, and forward to the EU Notified Body for verification. The Notified Body will review the documents for completeness and may request any missing information. Upon successful review, the Notified Body will give permission to the manufacturer to affix CE mark in accordance with EU requirements. The manufacturer can then market its CE-marked products in the EU. For additional information, you may visit the FDA web site at http://www.fda.gov/cdrh/mra/index.html.

MRA Scope

The scope covered under the MRA is as follows:

1. Medical Device Directive (MDD) 93/42/EEC

   { Annex 2, Complete Quality Assurance (with the exception of section 4)
   { Annex 3, EC Type Examination
   { Annex 4, EC Verification
   { Annex 5, Production Quality Assurance
   { Annex 6, Product Quality Assurance

2. Active Implantable Medical Devices (AIMD) Directive 90/385/EEC

   { Annex 2, Full Quality Assurance (with the exception of section 4)
   { Annex 4, EC Verification
   { Annex 5, Production Quality Assurance

3. For list of covered products please refer to Tables under the Medical Devices Sectoral Annex in the text of the MRA that can be accessed at http://www.fda.gov/cdrh/mra/devmrareview.html.

CAB Qualification Procedures

Preliminary Qualification

NIST in cooperation with FDA and European Commission developed a checklist entitled, "Checklist for Evaluating Candidate Conformity Assessment Bodies (CABs) Seeking to be designated as U.S. CABs and/or participate in US-EU MRA Confidence building Program." This checklist is based on EU MEDDEV 2.10/2 document. A candidate CAB will provide the following documentation:

1. a cover letter requesting to participate in the preliminary qualification process for CAB nomination for medical devices under the US-EU MRA,
2. a detailed documentary proof for the following sections in the checklist:
   Section 1.0, General Requirements
   Section 2.0, Independence Requirements
   Section 3.0, Impartiality Requirements
   Section 4.0, Competence Requirements
   Section 6.0, Confidentiality Requirements
   (If the initial review based on above sections is successfully completed, information and documentary proof for the remaining sections of the checklist will be requested.)
3. a copy of the accreditation certificate for compliance with ISO/IEC Guide 62 from a nationally or internationally recognized accreditor and acceptable to NIST,
4. copies of accreditation certificates for compliance with ISO/IEC Guide 65 if scope includes EC Verification and/or Type Examination,
5. proof of familiarity with requirements of Medical Device Council Directive 93/42/EEC through work experience if this scope is desired by the CAB,
6. proof of familiarity with the requirements of Implantable Medical Devices Council Directive 90/385/EEC through work experience if this scope is desired by the CAB,
7. specify the product groups of interest as noted in the MRA text.

Upon receipt of the above documentary proof, NIST/FDA will thoroughly review the material for completeness and accuracy. Additional documentation may be requested, if the original documents are found to be incomplete. Upon successful review, FDA (upon NIST recommendation) will nominate the candidate CAB to the European Commission pending formal accreditation for medical devices and in accordance with the EU Directive(s) by an accreditor acceptable to NIST.

RvA Accreditation

RvA of Netherlands has agreed to formally accredit U.S. CABs for EU requirements for the Medical Devices sector of the US-EU MRA. The candidate CAB will follow the following procedure

1. The candidate CAB will send a formal request to RvA for accreditation or scope extension for the desired Council Directive(s), the annex(es), and the product groups if applicable.
2. The candidate CAB will declare its intension to RvA to become a U.S. CAB (similar to an EU Notified Body) under the US-EU MRA.
3. RvA will conduct on-site assessment and field audits for compliance with appropriate ISO/IEC Guides and EU requirements. The RvA will pay particularly attention to the following items:
   1. Independence
      
   2. Qualifications of technical personnel for medical devices
      
   3. Hands-on experience of technical personnel
      
   4. Knowledge of the medical devices directives
      
   5. General knowledge of the medical devices technology
4. FDA/NIST may conduct an on-site assessment for specific elements of MEDDEV 2.10/2 document to complement RvA assessment. [As an alternate FDA/NIST may observe the on-site assessment conducted by RvA at candidate CAB's office.]
5. FDA/NIST and EU's NB/DA will observe three joint audits. The EU DA must participate in at least the third joint audit.
6. Upon successful completion of the assessment, RvA will issue an accreditation certificate for the qualified scope(s).

CAB Designation for the transitional phase

1. The candidate CAB will submit the following documentation to NIST/FDA:
   
   1. a cover letter requesting CAB designation under the US-EU MRA,
      
   2. a copy of the accreditation certificate for medical devices. Specify the desired scopes for the Council Directives, specific Annexes, and products scopes if applicable,
      
   3. the names of the qualified technical staff who will conduct specific functions under the MRA.
2. Upon receipt of the above documentation, NIST/FDA will thoroughly review the material for completeness and accuracy along with the results of the joint audits. Additional documentation may be requested, if the original documents are found to be incomplete.
3. Upon successful review of the documents, NIST will recommend to FDA the designation of the CAB to the European Commission. Please note that accreditation and designation are two separate functions. FDA is the designating authority for the Medical Devices sector under the US-EU MRA and may require further clarifications from the candidate U.S. CAB.

List of nominated U.S. CABs for the transitional period can be accessed at: http://www.fda.gov/cdrh/mra/listuscabs.html.

A Guide to EU Active Implantable Medical Devices Directive: http://ts.nist.gov/ts/htdocs/210/gsig/cainfo.htm under the heading "Mutual Recognition Activities - Regional"

Global Harmonization Task Force

The Global Harmonization Task Force (GHTF) is a voluntary group of representatives from national medical device regulatory authorities and the regulated industry. The purpose of the GHTF is to encourage

- Convergence in regulatory practices related to ensuring the safety,
- Effectiveness / performance and quality of medical devices,
- Promoting technological innovation and facilitating international trade, and
- The primary way in which this is accomplished is via the publication and dissemination of harmonized guidance documents on basic regulatory practices.

These guidance documents, which are developed by four (4) different GHTF Study Groups, can then be adopted/implemented by member national regulatory authorities. These documents and other information about GHTF can be obtained at http://www.ghtf.org/. The GHTF procedural documents are also available at this web site that include a) GHTF Roles and Responsibilities, b) GHTF Guiding Principles, c) GHTF Operating Procedures, d) Document Format & Style Guide, and e) Document Template.