Hello Anon,
Annex I is the General Safety and Performance Requirements or GSPR which can be used as a matrix or using a traceability type of approach to show how the safety and performance characteristics (including all the risk assessment) are being met. Typically companies use a tabular listing of the requirements with showing how compliance is met and supporting documentation. The GSPR, Annex I, will be new to a lot of IVD companies as this was not strongly enforced or reviewed under the EU IVDD. If you already have done an Essential Requirements against Annex I of the EU IVDD, then certainly should perform a gap assessment against the new EU IVDR Annex I - there are some differences. Annex II is your Technical Documentation, again may not have been strongly enforced under the Directive. However, following Annex II and the STED structure can really help build a Technical Documentation index type file where it would reference and show all the supporting technical information related to the product. Keep in mind too, IVDs need to now have a Performance Evaluation which is probably going to be the most daunting for many IVD companies.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 15-Mar-2020 16:51
From: Anonymous Member
Subject: IVDR (ANNEX I and ANNEX II)
This message was posted by a user wishing to remain anonymous
I have an existing product that meets IVDD requirements. I need to do a gap analysis to the IVDR, ANNEX I and ANNEX II.
Has anyone had any issues evaluating each concurrently by different individuals? Is it recommended to do them sequentially since ANNEX I plugs into ANNEX II? Any advice is appreciated.