The deadlines to comply with the EU’s new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) may seem far off (May 26, 2020 and May 26 2022, respectively), but given the breadth of the regulations, manufacturers need to have a plan in place now to ensure compliance by the deadlines.

Manufacturers need to embark on a comprehensive review of their current processes – from product development to post market surveillance. The entire product portfolio must be examined to determine product strategy in light of the new regulations, which may require classification changes and thus, re-certification under the new rules.

Manufacturers also need to ensure that their clinical investigations meet the higher MDR and IVDR standards. In addition to stricter clinical evidence requirements, manufacturers will also need to comply with new technical documentation and labeling requirements which includes the EU version of Unique Device Identification (EU UDI).

Stricter post market surveillance (PMS) requirements necessitate additional documentation as well. Under the new rules, certain manufacturers will need to maintain PMS reports and comply with shorter notification and reporting timeframes.

In short, the new regulations will require almost all manufacturers to adopt significant process changes to ensure compliance… A comprehensive understanding of the MDR and IVDR and their implications is necessary for effective risk analysis, planning and process change implementation.

Validant has the expertise to ensure that your company is EUMDR and IVDR compliant. Our three-phase proprietary approach (Gap Assessment, Design/Pilot and Implementation/Remediation) is designed to thoroughly assess your operational and development processes, identify problem areas and make specific recommendations for successful implementation. Within each phase, our experts work with individuals across departments (from Clinical, QC and R&D to Supply Chain, Engineering and IT) for effective cross-functional collaboration. Whether the new regulations require you to overhaul your current processes for several product lines or you only have a few affected products, Validant will work with you and your team to determine strategy and a plan for compliance.

Validant will help you successfully navigate EUMDR and IVDR compliance.