New Legal Challenges to the Medical Device Industry

The MDR and IVDR bring a number of new legal challenges to the industry, mainly stemming from the new economic operator regime that will require a thorough review of contractual relationships in the supply chain and additional product liability rules that make the authorized representative jointly and severally liable and well as require a review of the product liability coverage of the manufacturer. Larger companies with multiple economic operators in their corporate group will need to determine what resources can be pooled between the various economic operators under their control and how. In addition the regulations contain new advertising and marketing rules that require additional controls in the organization.