MDSAP Updates Special Remote Assessment Procedure
The Medical Device Single Audit Program, MDSAP, has issued version MDSAP AS P0014.004 of its Special Remote Assessment Procedure.
The procedure has a version date and effective date of 1 September 2026 and identifies Marc-Henri Winter, USFDA, as project manager.
Purpose of the Procedure
The procedure describes the process for performing Special Remote Assessments of an Auditing Organization, or AO, within the MDSAP framework.
According to the document, Special Remote Assessments are used to verify the effective closure of nonconformities, investigate complaints, and collect and evaluate information in response to significant changes or other information received by MDSAP regulatory authorities.
Scope
The procedure applies to the MDSAP Assessment Program Manager, or APM, assigned to the auditing organization and to the assessors selected to perform the assessment.
The document also defines key acronyms used in the process, including APM for Assessment Program Manager, ATLfor Assessment Team Leader and AO for Auditing Organization.
Responsibilities
The Assessment Program Manager is responsible for planning and scheduling Special Remote Assessment activities, selecting assessors, reviewing outcomes and determining their impact on the recognition decision and the AO assessment program.
The APM also forwards the results of the Special Remote Assessment to the Technical Review and Recognition Committee, or TRRC.
Assessors are responsible for reviewing and analysing the AO’s management system documentation and other requested documents, and for documenting the assessment results in a documentary assessment report.
Planning Phase
The procedure states that the APM may initiate a Special Remote Assessment in several situations.
These include verifying the closure of AO nonconformities, reviewing an application for scope extension, investigating a notification of significant changes, investigating complaints about the AO, assessing implementation of new or modified recognition criteria, responding to concerns raised during inspection of a medical device manufacturer, or confirming activities at a Critical Location where an on-site assessment is unwarranted or impractical.
The APM informs the AO of the required activity through an audit announcement letter, which describes the purpose of the assessment, details the information to be submitted and includes a deadline, typically 15 calendar days, for submitting the information.
Assessor Selection and Documentation
Once the AO submits the required information, the APM reviews the submission for completeness. If the submission is incomplete, the APM informs the AO in writing and requests the missing information.
After a complete submission is received, the APM identifies the assessor competencies required and selects an assessor who meets those competency requirements. For follow-up Special Remote Assessments resulting from AO nonconformities, the preferred assessor is the Assessment Team Leader from the audit where the nonconformities were issued.
The APM then provides the assessor with information submitted by the AO and relevant background information, such as past nonconformities, corrective action evidence, scope extension applications, notices of change, complaints, AO responses and medical device manufacturer inspection reports.
Documentary Phase
During the documentary phase, the assigned assessor evaluates the evidence provided by the AO against the recognition criteria and documents the results of the evaluation.
If the evidence is insufficient to draw a reliable conclusion of conformity, the assessor may request additional information or evidence. Such requests should be issued with short response deadlines.
Optional Interactive Phase
The procedure allows an optional interactive phase.
If helpful, the assessor may set up a teleconference with the AO to confirm conclusions drawn from the review of submitted documentation. In that case, the assessor informs the APM and liaises with the AO to schedule the teleconference.
Follow-Up and Decision-Making
After the assessment is completed, the Special Remote Assessment report and any necessary nonconformities are completed and forwarded to the APM.
The APM reviews the assessment report and any associated nonconformity reports, advises the AO of the results and forwards the report with any issued nonconformities. Nonconformities are recorded using MDSAP AS F0015.2 AO Nonconformity Report.
The APM then determines whether the assessment objectives were satisfied, whether additional assessment activities are needed, whether the AO Assessment Program Management File should be updated, and whether recommendations should be made on ongoing recognition, re-recognition, scope expansion, scope modification or reduction, suspension, or revocation of recognition.
The Special Remote Assessment file is forwarded to the TRRC for review and decision under the MDSAP Technical Review and Recognition Decision Making Procedure.
Forms and Reference Documents
The procedure identifies three related forms:
MDSAP AS F0014.1 — Special Remote Assessment Flowchart;
MDSAP AS F0014.2 — Special Remote Assessment Report;
MDSAP AS F0015.2 — AO Nonconformity Report.
Reference documents include ISO/IEC 17021-1:2015, IMDRF/MDSAP requirements for medical device auditing organizations, regulatory assessor competence and training requirements, the MDSAP Assessment Program Procedure and the Technical Review and Recognition Decision Making Procedure.
Change History
The document history shows that version 004, dated 1 September 2026, was migrated to the new template and includes minor editorial changes.
The approval page confirms version 004 and indicates approval by the Chair, MDSAP RAC, dated 2026/09/01.
Impact on Auditing Organizations and Medical Device Manufacturers
For MDSAP-recognized auditing organizations, the updated procedure reinforces how MDSAP regulatory authorities may use remote assessments to follow up on nonconformities, investigate complaints, evaluate significant changes and assess issues affecting recognition.
Auditing organizations should pay particular attention to:
readiness to respond to audit announcement letters;
timely submission of requested information, typically within 15 calendar days;
completeness of evidence submitted to the APM;
documentation supporting corrective actions;
management of significant changes;
complaint investigation support;
scope extension documentation;
potential teleconference participation;
possible issuance of AO nonconformity reports;
impact on recognition, re-recognition, scope changes, suspension or revocation.
For medical device manufacturers relying on MDSAP-certified auditing organizations, the procedure is relevant because it supports oversight of AO performance and helps maintain confidence in the MDSAP recognition framework.
