Hello Vidyalakshm,
As long as the technical documentation required as per MDR Annex II are referenced in the TF and readily available for review, it does not have to be controlled as a single document. With that said, the full set of such documentation will have to be submitted for NB's review for CE certification, and some information must be directly included in certain documentation according to relevant requirements in the MDR
For CER & CEP, certainly these must be included in the technical documentation. Article 61 Clinical evaluation, 12.The clinical evaluation, its results and the clinical evidence derived from it shall be documented in a clinical evaluation report as referred to in Section 4 of Annex XIV…….. shall be part of the technical documentation referred to in Annex II relating to the device concerned". The MDD Annex X stated: "….This documentation shall be included and/or fully referenced in the technical documentation of the device.".Comparing the language between the MDD and MDR, it is clear now that a summary or a reference can no longer be accepted under the MDR.
For PMCF, they are part of the CER updates, and summary of it will be part of your Periodic Safety update report (Article 86), therefore will become part of the Technical Documentation.
Don't forget that Annex III (Technical documentation on post-market surveillance) now needs to be part of the technical documentation.
For V&V: Section 6 of the Annex II states "The documentation shall contain the results and critical analyses of all verifications and validation tests and/or studies…." That is pretty much what would be in the V&V reports. I interpret this as the manufacturer has the option to include the full description of the results with the analysis, or have as brief summary and attach the final reports. Only A brief summary or a pointer can no longer be accepted, regardless of the classification of the device.
When it comes to 6.2 e (packaging, sterilization and maintenance of sterility), it is clearly requested that that validation reports must be included in the technical documentation.
What do you think of section 2 of Annex II? It is required to submit complete set of labels in the languages accepted in the Member States where the device is envisaged to be sold. What if you have to correct some of the wording in the IFU based on the NB's review? Will you repeat all the translations?
And section 3 of Annex III?a. design stages, and b. manufacturing information & validation
Technical documentation will become a living document, many of the reports part of it has yearly frequency of updates. Under the MDD, technical documentation used to be updated right before CE re-certification, this will no longer be the case with the MDR.
At Qserve Group we help many manufacturers prepare of the MDR compliance by reviewing their Technical files, CERs and QMS. If you need any assistance, please contact us on our website: http://www.qservegroup.com/
Hope this helps.
Best regards,
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Rania Gerges
Qserve Group Consultant
http://www.qservegroup.com/Palm Beach Gardens FL
United States
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Original Message:
Sent: 23-Jul-2018 15:15
From: Vidyalakshmi Jayaraman
Subject: GSPR Checklist
Hi Rania,
Annex II of the MDR confuses me. Are we now required to include all of the pages of CER, CEP, PMCF, V&V testing reports etc in the Tech File now as opposed to having pointers (only document numbers reside in the TF now; individual reports are readily searchable in our document control system using the doc number). If it is the former, the TF will be a 2000 page document which is impractical.
I would appreciate your insights.
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Vidyalakshmi Jayaraman
RA Specialist
Marlborough MA
United States
Original Message:
Sent: 10-Jul-2018 10:38
From: Rania Gerges
Subject: GSPR Checklist
Hello Bob,
The contents and format of the Technical File are not the same under the MDR.
Just to list few differences here beside the GSPR checklist:
- Basic UDI-DI
- the intended patient population and medical conditions need to be specified (if it was not part of the TF under the MDD)
- the rationale for the qualification of the product as a device
- A complete set of the label or labels on the device and on its packaging...………
- the instructions for use in the languages accepted in the Member States where the device is envisaged to be sold
- complete information and specifications, including the manufacturing processes and their validation, their adjuvants, the continuous monitoring and the final product testing. Data shall be fully included in the technical documentation;
- identification of ALL sites, including suppliers and sub-contractors, where design and manufacturing activities are performed (not only critical ones).
- The documentation shall contain the results and critical analyses of all verifications and validation....(not just summary or references to the final reports as many used to do under the MDD)
- The clinical evaluation report and its updates and the clinical evaluation plan
- Annex III documentation on Post Market Surveillance (PMS Plan, PMS report/or PSUR)
- The PMCF plan and PMCF evaluation report referred to in Part B of Annex XIV or a justification why a PMCF is not applicable.
- and more...
Also you have to consider the new classification rule numbers and conformity assessment routes and if your device classification changed under the new rules.
Best regards,
Rania
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Rania Gerges
Palm Beach Gardens FL
United States
Original Message:
Sent: 09-Jul-2018 20:40
From: Robert Wilkinson
Subject: GSPR Checklist
Has anyone prepared and gained NB approval of a GSPR Checklist that complies with Annex 1 of the MDR (2017/745) which replaces the ER Checklist required by the MDD (93/42 EEC) that you would be willing to share. Since there has been no formal change to the content and format of the Technical File, I assume that following the requirements of NB-MED/2.5.1/Rec5 would be acceptable. Any comments.
Thanks,
Bob
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Robert Wilkinson
President
Port Barrington IL
United States
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