Medical Device News Magazine

Renishaw Granted EU MDR Approval for Medical Devices

About Medical Device News Magazine

About Medical Device News Magazine. We are a digital publication founded in 2008 located in the United States.

Advertise with Medical Device News Magazine! Join Our #1 Family of Advertisers!

We pride ourselves on being the best-kept secret when it comes to distributing your news! Our unique digital approach enables us to circulate your...

Renishaw, a global engineering company pioneering robotic neurosurgical solutions, announces that the company’s neuromate® stereotactic robot, incorporating neuroinspire™ surgical planning software, has received EU Medical Device Regulation (MDR) certification from its Notified Body, the British Standards Institution (BSI).

As one of the first companies to achieve MDR approval, Renishaw reaffirms its commitment to the market, its customers and, most importantly, the patients who will continue to benefit from the use of its products.

In a move that became one of the most significant shifts in European medical device regulations in over two decades, the MDR 2017/745 replaced the European Directives on Medical Devices (AIMDD 90/385/EEC and MDD 93/42/EEC) in May 2021. The goal was to create a more modernised, robust and long-term legislative framework for medical devices, as well as software that is used by those devices, with strict inspection by Notified Bodies to assure the highest levels of safety and health.

The introduction of the MDR 2017/745 means more stringent requirements, particularly in the area of clinical and post-market review data, are in place. As a result, many medical device companies within the EU have had to make significant time and financial investments to improve their current processes to capture and analyse this data.

“Achieving MDR certification is a significant achievement for Renishaw and is the result of months of hard work, dedication and due diligence within our team”, said Nina Sainte-Marie, Operations Manager at Renishaw. “Without this and the early adoption of the new regulatory requirements in Europe, certification would not have been possible. I am especially proud to be part of a team that values quality so highly and is committed to establishing compliance within the new EU regulations.”

Paul Skinner, General Manager at Renishaw, commented: “The replacement of the MDD with the MDR has improved the standards for medical device regulation within Europe and we are delighted to be one of the first neurosurgical solutions companies to receive certification. Not only does it reaffirm our commitment to compliance with the evolving regulatory requirements for medical devices but is testament to our progress in meeting the standards required for approval of the neuromate robot and neuroinspire planning software. Thanks to the Renishaw team we’re able to continue supply within Europe and reach our ultimate goal of ensuring patients have access to life-changing neurosurgical devices.”

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Other News

Radical Catheter Technologies Presents Analysis of Disruptive, Recently FDA-Cleared Endovascular Technology at the Society of NeuroInterventional Surgery 21st Annual Meeting

This new catheter, the first product commercialized from this novel technology platform, is designed to enable access to the blood vessels in the brain for both femoral and radial access. A multi-center analysis of this disruptive technology is being presented today at Society of NeuroInterventional Surgery 21st annual meeting. In addition, the Company confirmed the closing of a $20 million financing round led by NeuroTechnology Investors, which will be used to scale the company and expand the Radical platform notes Radical Catheter Technologies.

Rapid Medical™ Completes Initial Neurovascular Cases in the USA Following FDA Clearance of Its Active Access Solution

“With DRIVEWIRE, our design goal was to bring new levels of access and control to the interventional suite while improving best-in-class guidewires,” comments Giora Kornblau, Chief Technology Officer at Rapid Medical. “When physicians are looking for technologies that increase the clinical possibilities and safety for the patient, we want Rapid to be the first place they look.”

HeartFlow Introduces Next Generation Interactive Plaque Analysis Platform to Assess Patient Risk in Suspected Coronary Artery Disease

The HeartFlow Plaque Analysis uses proprietary algorithms to analyze coronary CT angiogram (CCTA) scans, creating a personalized 3D model that quantifies and characterizes plaque volume in the coronary arteries, aiding risk assessment of coronary artery disease. The technology was introduced at the Society of Cardiovascular Computed Tomography (SCCT) Annual Scientific Meeting in Washington, D.C.