We support worldwide clients in the evaluation of clinical data documented as Clinical Evaluation Reports along with related documents which are part of the technical documentation, followed by assisting with submission to the notified body as part of the official conformity process for your medical device(s).for more info visit:https://www.makrocare.com/devices/clinical/clinical-evaluation-reports
EU MDR (The European Union Medical Device Regulation) is a regulatory framework applies to all medical device manufacturers and distributors intended to improve the safety of healthcare and the performance of medical devices in Europe.
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 deviceNeed confirmation of BSI to carry out the workThe submission therefore will include:The Cover letterIn 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 discussionBSI ref # for relevant submissionA brief explanation of what has been submitted and how it demonstrates compliance, what is affected and what is not?Technical DocumentationNew 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 ChecklistBelow 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 submissionManufacturer personnell supportManufacturers need to ensure that proper resources like RA, QA, R, manufacturing, etc are available during documentation.
The more quickly information is provided the more quickly the documentation can be closed towards the documentation.Document AvailabilityEnsure proper availability of documents with proper references.
