Covid-19 is starting to have a huge impact on all companies big and small. At IVDeology we are all fit and healthy but have taken the steps to self-isolate and work remotely from home (I am writing this from my kitchen!). While we miss the interaction that being in an office can bring, we are learning how to work more effectively using remote tools. At this point your company may be doing the same thing.
It may be challenging for companies to find suitable remote working activities, especially as many roles within IVD manufacturing cannot be performed working from home. However, with the IVD Regulation coming into force in just over 2 years time this is the perfect time to engage with all functions to consider the impact of the IVDR on your products.
The generation of product Technical Files should be a cross-functional activity that requires a collective effort across the business. Much of this can be done remotely by non-regulatory or quality experts. Here are some questions you could ask yourself:
- How does the intended use statement described within the IFU meet the requirements of the Intended Purpose statement required within Annex I and Annex II?
- Have you laid out a structure for your technical documentation aligned to Annex II?
- Is your performance data well organized, clear and unambiguous? Can all reports be logged and labelled so that they can be easily found?
- Is your Risk Management file up to date?
- Have you generated or reviewed your Scientific Validity for all your devices?
IVDeology aim to be the UKs leading provider in IVD regulatory and quality services and we have the tools and a number of experts who can support your teams in the assessment and remediation of IVD technical documentation, either in person, or remotely as part of Covid-19 self-isolation!
For further information on what you need to know, and how we can help contact us [email protected]
