USDM Life Sciences, the leading risk management, technological innovation and business process optimization firm for the life sciences and healthcare industries, is already working with medical device manufacturers to comply with the two new European Union medical device regulations.
On April 5, 2017, the In vitro Diagnostic Medical Devices Regulation (IVDR) and Medical Devices Regulation (MDR) were approved by the European Parliament.
USDM has been actively following these regulations and is already working with their medical device clients to help plan their regulatory understanding, strategy and implementation. Jay Crowley and Grant Hodgkins oversee medical device compliance services and solutions for USDM.
Crowley is the author of the US FDA UDI Final Rule and is Vice President of UDI Services and Solutions at USDM. Hodgkins was a senior manager at Novartis and Alcon for Master Data Management (MDM) and Product Identification and is the Vice President of Commercial Services and Solutions at USDM.
“These directives are the most recent steps in the global rollout of new medical device identification regulations. These steps, along with the US FDA UDI Final Rule and other similar regulations from other countries that are expected soon will continue the worldwide initiative to improve medical device identification, product quality and patient safety,” says Crowley. “We look forward to helping the industry with this important initiative.”
For medical device manufacturers selling devices in the EU, the timeline for compliance has begun – three years for MDR and five years for IVDR. USDM will continue to support Medical Device companies through its Knowledge Webinars, White Papers and participation in the European UDI Conference in Brussels May 16-18. and the US UDI Conference in Baltimore June 7 to 8. USDM is also presenting a webinar, New EU Diagnostics and Medical Device Regulations on April 20th.