MDR Gap Analysis Actions

Standard
EN ISO 10993-10:2023
EN ISO 80601-2-56
EN 62366
EN 60601-1-2
EN 60601-1-6
EN 60601-1-11
EN ISO 13485
EN ISO 14971
EN ISO 15223-1
EN ISO 20417
EN 60601-1:2006+A2:2021
EN 62366
EN ISO 10993-1
Actions
Review existing protocols and reports for the evaluation of skin sensitization, to determine whether these are in compliance w
revision of the standard and identify any deficiencies including, sample preparation, tests procedures, results and interpretatio
qualification of personnel and test laboratories.
Review the skin sensitization documentation to ensure that there is documented evidence that personnel involved are approp
trained and experienced. Review test results to confirm that these have not been interpretated as standalone results but have
interpreted alongside other information (Clause 7).
Ensure that a step-wise approach is adopted (Clause 4) to address any deficiencies identified. Clause 5.3.2 of EN ISO 10993-1:
(requirements for transitory-contacting medical devices) should be considered. Clause 4.11 of EN ISO 10993-1:2020 should als
taken into consideration.
Verify that, where applicable, gap assessments have been conducted or evidence of compliance has been documented for the
ISO 10993 series standards that may be associated with this standard (e.g. EN ISO 10993-1:2020, EN ISO 10993-12: 2021, EN IS
10993-23, ISO 10993-18 etc)
Review GSPR checklist and update with any amended skin sensitization related documents.
Review application of this standard to determine whether interpretation of new definitions of “may”, “can” and
“must” have been appropriately applied to test protocols/reports and device specifications.
Review test protocols/reports and device specifications to determine whether technical alarm conditions and
rated output range are in compliance with the standard requirements.
A full review of Usability Engineering documentation is required to verify compliance with this standard, with
particular reference to Annex C (Normative) which contains information for the evaluation of a User Interface
of Unknown Provenance (UOUP) and the guidance on interpretation of the standard as per IEC TR 62366-2
which provides generally accepted guidance on the application of usability engineering to medical devices.
Verify that early usability engineering activities include adequately defining the user profiles and user interface as outlined in t
amendment. If the usability engineering program is in compliance with IEC 62366-1:2015, it is likely aligned with this amendm
Product requirements, product testing, product labeling, need to be reviewed against new requirements.
Verify product meets the requirement is to have at least a level of ingress protection equal to 22.
Review all QMS SOPs against the tables in Annex ZA and update as need for elements that are either not
covered or partially covered.
Revise Risk Management Process (QAP-1008) as needed.
Update Risk Management documentation as required.
Revise QAP-1036 Product Labeling as needed.
All labeling and accompanying information must be reviewed against new symbology and revised as required.
Revise QAP-1036 Product Labeling as needed.
All labeling and accompanying information must be reviewed against new requirements concerning information to be supplie
manufacturer and revised as required.
A new test report according to EN 60601-1:2006+A2 can be requested from an external ISO/IEC 17025 accredited testing labo
If the current IEC 60601-1 test report uses CB-Scheme as test scheme, it should be kept in mind that according to IEC Operatio
Document OD-2037 clause 3.1, a new Certification Body (CB) test certificate shall be issued with a new CB test certificate num
A full review of Usability Engineering documentation is required to verify compliance with this standard, with particular refere
Annex C (Normative) which contains information for the evaluation of a User Interface of Unknown Provenance (UOUP) and th
guidance on interpretation of the standard as per IEC TR 62366-2 which provides generally accepted guidance on the applicati
usability engineering to medical devices.
A thorough documented review of the entire biological evaluation documentation is recommended to demonstrate full comp
with this standard.
Notes
Engineering to perform internal

testing
- Rishi to perform testing on EU
products
- Mike R. to create timeline by
Tuesday Engineering meeting
TAT-2000-BT - Perform full testing

prior to release
Remove reference to Management

Review
Perform summative Usability testing

MDR Gap Analysis Actions

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Standard

Engineering to perform internal

TAT-2000-BT - Perform full testing

Remove reference to Management

Perform summative Usability testing

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