In the blog post “IVD Directive to IVD Regulation Transition – 8 months remaining”, my colleague outlined some key focus areas that IVD manufactures should pay attention to, such as classification, Notified Body and QMS, etc.
Some key dates are highlighted in the below figure.
Despite widespread industry calls to delay implementation no extension has been granted. So, are you ready? The amount of effort required to prepare is dependent on several factors, including:
- Device classification (including whether the device contains or is, in its own right, software)
- Availability of Notified Bodies (there are currently six designated under IVD Regulation)
- Device prioritisation (classification, cost vs benefit of compliance to IVDR, legacy data availability).
To help understand where you are with your transition planning, we prepared a checklist which covers areas such as:
- Device classification
- CE mark certification validity date
- Economic Operators
- Status of Clinical Evidence
- Technical Documentation
- Post Market Surveillance Planning.