Everyone is aware of the delay in the submission of EU MDR guidelines. This was mainly due to the improper submission of technical documentation of the MDR checklist. The common issues which BSI was facing while reviewing the documentation of medical devices are:
- Manufacturers were not able to provide all the information about the device that is necessary for review.
- There was a poor representation of data.
- Technical information of the device was difficult to locate.
To reduce these error rates, BSI set the proper format to submit the MDR audit checklist with a Subject Title: “MDR Documentation Submissions: Best Practices Guidelines”.
For any technical documentation review we need the below 3 things:
- Context explaining what is requested and why?
- Technical documentation of device
- Need confirmation of BSI to carry out the work
The submission therefore will include:
- The Cover letter
In a cover letter following details are necessary to include:
- Certificate # or Reference #
- Type of review like a new device, change in design, shelf life extension, etc.
- Brief product discussion
- BSI ref # for relevant submission
- A brief explanation of what has been submitted and how it demonstrates compliance, what is affected and what is not?
- Technical Documentation
New MDR requires submission of technical documentation with a complete set of documents even for the devices which are already certified under MDD or AIMD regulations.
We help you to create the MDR audit readiness checklist with proper guidance on what documents are required.
- Submission Process Authorization
A quotation with a signature is required before preceding the submission process. If it is not ready then please contact the BSI scheme manager or BSI sales team.
Procedure to Submit MDR Audit Readiness Checklist
Below are some guidelines to submit this process:
- Notify BSI about an application to review. New clients can submit the checklist via the sales team and previous clients can ask their scheme manager or a member of the administration team.
- Submit the checklist with a formal quotation.
- After submission of the signed quotation, BSI will assign UIN or relevant certificate number for your review.
- Manufacturers have to submit the MDR audit readiness checklist prior to the start of the detailed review process. This ensures that all documents are included as a part of technical documentation
- The final assessment of the technical documentation can begin after receiving the signed quote together with all required documents.
Important things to consider while preparing Technical documentation for submission
Manufacturer personnell support
Manufacturers need to ensure that proper resources like RA, QA, R&D, manufacturing, etc are available during documentation. The more quickly information is provided the more quickly the documentation can be closed towards the documentation.
Document Availability
Ensure proper availability of documents with proper references. Like if a document includes references or hyperlinks make sure that they are working.
Use of Language
For maintaining the quality systems, the manufacturer should use the proper translation procedure to translate the document labeling, SSCPs, product claims in marketing materials, instructions for use, etc.
This is required because inadequate translation can break the safety and claimed performance of the device. This in result will provide inadequate information about the device to end-users.
Certification Scope
Sometimes you require additional efforts for the addition of new products, or even when changing the existing product. This can even affect the quality system certificate.
If the certificate of the existing product does not cover the drawbacks of the device, then you have to engage your extra time for requesting certificate re-issuance. Moreover, you should review sufficient evidence prior to submitting it for review by BSI.
If there is any doubt about the documentation discuss the scope with the BSI scheme manager prior to submission for review.
A well-designed audit management system supports efficient management of audit checklists and supporting the auditing process.
Mobiom’s cloud-based data access with offline compatibility is one such tool that allows auditors to complete checklists.
Even when auditing at remote locations without proper network coverage.
Mobiom allows compliance audit checklist to be completed offline and synced with the database when back in network range.
