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UK MHRA Releases Contingency Legislation Covering Regulation of Medical Devices in Brexit ‘No Deal’ Scenario

On the 24 January 2019, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) published contingency legislation which provides regulatory guidance for medicines, medical devices and clinical trials in the event that the UK departs the EU with no agreement on 29 March 2019. The Secretary of State, Stephen Hammond, also signed off on the … Continued

EU Commission Updates Website to Provide Additional MDR and IVDR Planning Resources

The EU Commission’s website dedicated to Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) planning has recently been updated, and now includes a new and dedicated page for preparation of the new regulations. This online resource, found here, includes a tool for stakeholders and Economic Operators to search for information specific to their … Continued

Renewal Timelines Quickly Approaching for Medical Device Directive (MDD:M5) CE Mark Certificates

The countdown for the EU Medical Device Regulation (MDR 2017/745 EU), what will soon be the only governing EU medical device regulation, is quickly approaching. The compliance deadline of May 2020 may seem quite far away, but with a significant reduction in Notified Body capacity, a sizable increase in demand for regulatory certification services is … Continued

NAMSA Announces Acquisition of Reimbursement Strategies, LLC, Expands Medical Device Development Portfolio

TOLEDO, OHIO (BUSINESSWIRE)—January 7, 2019—NAMSA®, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory testing, clinical research and regulatory consulting services, is pleased to announce the acquisition of Reimbursement Strategies, LLC, a Minneapolis-based consultancy focused on reimbursement, health economics and market access for the international life science industry. For … Continued