EU MDR postponement; FDA approvals

Manufacturing incident report solution for EU MDR report automation

The Manufacturing Incident Report (MIR) solution for EU MDR incident report automation from AssurX aligns business logic with an up-to-date MIR template published by the European Commission (EC). The solution ensures information accuracy, submissions timeliness, and transparency. The MIR solution enables automated MIR documentation and submission according to guidelines and reporting time frames. It is pre-configured to conform to EU quality and compliance standards and automates completion of MIRs electronically. Teams can export the report in readable formats for review by internal teams or an authorized representative.

EU MDR compliance postponed one year

The European Parliament voted to postpone the Medical Devices Regulation (MDR) to May 26, 2021, just two weeks after the European Commission proposed the delay because of disruptions caused by the COVID-19 pandemic. Next, it must be approved by member states and published in the Official Journal. It’s expected to be formally enacted by May 26, 2020. The delay only applies to the MDR and the regulatory requirements remain the same for medical device manufacturers, notified bodies, authorized representatives, importers, and distributors

Growing expandable orthopedic portfolio

Huntley, Illinois-based Life Spine, a growing Huntley portfolio company, has received an additional clearance from the FDA to market the Lateral Prolift Expandable System. The company also plans to launch 20 new products, including six Micro Invasive Expandables, in 2020.

Life Spine’s current expandable portfolio includes:

• Lateral Prolift Expandable System
• 10mm and 12mm Prolift Expandable Systems for transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF) approaches
• Aileron TRX Expandable Interspinous Spacer
• Longbow Expandable Lateral Spacer System
• Longbow Expandable TLIF Spacer System
• TiBOW Expandable Spacer System with horizontal expansion for a TLIF approach

Single-use micro-endoscopes

EnlightenVue’s surgiVue single-use micro-endoscopes received 510(k) marketing clearance, allowing the company to market them for multiple clinical and surgical procedures. The micro-endoscope is single-use and doesn’t require cleaning and/or re-sterilization (for more on endoscopes, see feature, pg. 36), eliminating the risk of patient-to-patient transmission of microorganisms caused by diffiicult-to-sterilize reusable endoscopes. The surgiVue allows for a combination of diagnostic and interventional procedures, simplifies the patient’s overall experience from diagnosis to treatment, and gives the provider a wide range of clinical options.