Description: When manufacturers apply the CE mark to their devices, they are signifying that the product has met EU health, safety, and environmental requirements. Manufacturers are not only responsible for compliance to the MDR/IVDR, they must also make sure all other related legislation that applies to their product are addressed. This includes a number of existing regulations such as the Machinery Directive, PPE, REACH, RoHS, and WEEE. Just in case regulatory professionals did not yet have enough on their plate, in the midst of transitioning to the MDR/IVDR, there are a number of new regulatory compliance challenges, such as the EU Artificial Intelligence Regulation and new sustainability regulations, that are emerging at the same time. It is critical that regulatory professionals are aware of related legislation and how it may be applicable to their devices. This session will include a panel of speakers with expertise in some of the key emerging related legislation that impact devices covered under the MDR and IVDR. The speakers will introduce these regulations and the expected impact these regulations will have on medical and in-vitro diagnostic devices. The discussion will include some of the new requirements that are emerging as a result of the European Green Deal, impacting chemicals and materials that are permitted in devices and packaging. Speakers will debate the impact of the EU Artificial Intelligence regulation on all devices with software, and the impact of the major revisions in the Pharmaceutical regulation on combination devices. Participants will be able to assess which new regulations are relevant to the products that they work with. This knowledge and awareness is the first step to ensuring that they stay ahead of the emerging requirements and are able to implement these new requirements in a timely and educated manner.
Learning Objectives:
Understand how related legislation interfaces with the IVDR and MDR
Identify relevant related legislation and the potential impact to products under the IVDR and MDR