IVD Manufacturers counting down to compliance and the new EU Regulations

IVD Manufacturers counting down to compliance and the new EU Regulations

IVD Manufacturers: Will you be Compliant with the new EU Regulation 2017/746 when it comes into effect on IVDR by May 2022?

Updated insights from our expert Tutor in Medical Devices John Lafferty

As we all know, EU Regulation 2017/746 on In-Vitro Diagnostic Devices (IVDR) comes in force on 26 May 2022 so you have 9 months left to prepare for this date and be fully compliant.

Five years after its publication there are now just nine months remaining for IVD manufacturers to make sure that their products and processes are compliant with the new regulation.

Be aware also that the scope of IVDR has been broadened

The scope of the IVDR has been broadened which may mean that some products that did not fall under the scope of the old IVDD could now have to be regulated as IVD Medical Devices. IVD device manufacturers will need to ensure that their devices and the processes used to manufacture them are compliant with the latest standards and guidelines on Risk Management, Process Validation and Software Validation and that relevant personnel are properly trained in these essential standards and guidelines.

If your team needs help in the area of training to prepare for IVDR then our expert Medical Device tutors are ready to provide this training for your employees and to assist your organisation to complete as seamless transition as possible to the IVDR.

View full details and training schedule for our Process Validation & Equipment Validation Training Programme

View full details and training schedule for our Quality Risk Management & ISO 14971:2019 Training Programme

View full details and training schedule for our Software Validation Training Programme

General information on the IVDR can be obtained on the HPRA website here