Medical Devices Directive

EQS-News: PRECISIS GmbH: EASEE – ­­­World's first minimally invasive brain pacemaker for the treatment of epilepsy receives CE-certification and is available immediately

Retrieved on: 
Friday, September 23, 2022

Heidelberg, 23.09.2022 after seven years of development work, Precisis GmbH, headquartered in Heidelberg, has received the CE certification for its minimally invasive brain pacemaker EASEE.

Key Points: 
  • Heidelberg, 23.09.2022 after seven years of development work, Precisis GmbH, headquartered in Heidelberg, has received the CE certification for its minimally invasive brain pacemaker EASEE.
  • These drug-refractory patients wait an average of 22 years before they are offered further technical or surgical treatment options.
  • With this new, risk-minimized EASEE method, the treatment spectrum is expanded in the early phases of the disease."
  • EASEE is an acronym for Epicranial Application of Stimulation Electrodes for Epilepsy.

BVI Announces Certification for its Intraocular Lens Portfolio under the European Medical Device Regulation

Retrieved on: 
Thursday, September 15, 2022

WALTHAM, Mass., Sept. 15, 2022 (GLOBE NEWSWIRE) -- BVI, a diversified global ophthalmic device company, today announced certification for its intraocular lens (IOL) portfolio under the European Medical Device Regulation (MDR, (EU) 2017/745) from its Notified Body, the British Standards Institution (BSI).

Key Points: 
  • WALTHAM, Mass., Sept. 15, 2022 (GLOBE NEWSWIRE) -- BVI, a diversified global ophthalmic device company, today announced certification for its intraocular lens (IOL) portfolio under the European Medical Device Regulation (MDR, (EU) 2017/745) from its Notified Body, the British Standards Institution (BSI).
  • The new regulatory criteria came into effect in May 2021, replacing the prior Medical Device Directive (MDD).
  • The MDR, representing the most significant change to European regulatory framework in decades, ensures a consistently high level of health and safety for medical devices.
  • Achieving and maintaining MDR certification is a major effort that requires a tremendous amount of investment, capabilities, and hard work, said Shervin Korangy, BVI President and CEO.

CIRCA Scientific's Quality Management System Awarded EU-MDR Certification

Retrieved on: 
Wednesday, September 7, 2022

ENGLEWOOD, Colo., Sept. 7, 2022 /PRNewswire/ -- CIRCA Scientific announced that the company has successfully met the requirements for certification of its Quality Management System (QMS) under the new European Union Medical Device Regulation (MDR) as of August 24th, 2022. To earn this certificate, BSI Group, CIRCA Scientific's notified body, completed a comprehensive conformity assessment and confirmed compliance of its QMS with the new, strengthened safety and performance requirements of the MDR. MDR certification allows CIRCA Scientific not only to continue to distribute its existing products in European markets but opens the door to proceed with its plans for new product developments and launches in the EU.

Key Points: 
  • ENGLEWOOD, Colo., Sept. 7, 2022 /PRNewswire/ --CIRCA Scientific announced that the company has successfully met the requirements for certification of its Quality Management System (QMS) under the new European Union Medical Device Regulation (MDR) as of August 24th, 2022.
  • To earn this certificate, BSI Group, CIRCA Scientific's notified body, completed a comprehensive conformity assessment and confirmed compliance of its QMS with the new, strengthened safety and performance requirements of the MDR.
  • MDR certification allows CIRCA Scientific not only to continue to distribute its existing products in European markets but opens the door to proceed with its plans for new product developments and launches in the EU.
  • I'd like to acknowledge the tireless work of our Quality Assurance team who managed all the activities required to establish compliance with the new regulation.

Endologix Receives CE Mark Certification under EU-MDR for AFX®2 Endovascular AAA System

Retrieved on: 
Thursday, August 4, 2022

Endologix LLC , a privately held global medical device company dedicated to improving patients lives with innovative interventional treatments for vascular disease, announced that is has received CE Mark Certification under the new EU Medical Devices Regulation [EU-MDR [(Regulation (EU) 2017/745)] for its AFX2 Endovascular AAA System.

Key Points: 
  • Endologix LLC , a privately held global medical device company dedicated to improving patients lives with innovative interventional treatments for vascular disease, announced that is has received CE Mark Certification under the new EU Medical Devices Regulation [EU-MDR [(Regulation (EU) 2017/745)] for its AFX2 Endovascular AAA System.
  • CE Mark certification under the new requirements is a high-bar and we are proud of this significant company achievement.
  • Meeting the rigor of the new framework is an important milestone for our AFX2 System, said Elisa Hebb, Endologixs EVP of Medical, Clinical, Regulatory Affairs and Quality.
  • Endologixs current commercial EVAR products include the AFX2 Endovascular AAA System and the ALTO Abdominal Stent Graft System.

DGAP-News:  Mercury Medical Receives EU Quality Management Medical Device (MDR) Certification

Retrieved on: 
Wednesday, July 27, 2022

CLEARWATER, FL / ACCESSWIRE / July 27, 2022 / Mercury Medical recently received MDR CE Mark Certification for their CPR manual resuscitation line.

Key Points: 
  • CLEARWATER, FL / ACCESSWIRE / July 27, 2022 / Mercury Medical recently received MDR CE Mark Certification for their CPR manual resuscitation line.
  • This certification ensures the quality system is in accordance with Regulation (EU) 2017/745 allowing for CPR product line sales in the European market.
  • The EU Medical Device Registration (MDR) replaces the EU's Medical Device Directive (93/42/EECI) thatwent into effect in May of 2021.According to the European Commission, (EC), no existing requirements have been removed but new requirements have been added to the MDR.
  • John Gargaro MD, President and CEO at Mercury Medical, states: "This is a HUGE milestone requiring a tremendous amount of resources to achieve MDR certification.

Fairtility Granted CE Mark Under New European Medical Device Regulation (MDR) for AI Decision Support Tool, CHLOE EQ™

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Tuesday, July 5, 2022

TEL AVIV, Israel, July 5, 2022 /PRNewswire/ -- Fairtility™, the transparent AI innovator powering in vitro fertilization (IVF) for improved outcomes, today announced its AI decision support tool CHLOE EQ™ earned the CE Mark under the European Medical Devices Regulation (MDR) regulatory requirements. CHLOE EQ™ is now commercially available to IVF fertility clinics across Europe.

Key Points: 
  • TEL AVIV, Israel, July 5, 2022 /PRNewswire/ -- Fairtility , the transparent AI innovator powering in vitro fertilization (IVF) for improved outcomes, today announced its AI decision support tool CHLOE EQ earned the CE Mark under the European Medical Devices Regulation (MDR) regulatory requirements.
  • CHLOE EQ is an AI decision support tool that was developed to provide Embryo Viability Assessment which supports the prediction of blastulation, the prediction of implantation and ploidy and, ranks embryos in order of priority.
  • The European MDR came into effect in May 2021 and serves as the new European legal framework for medical devices.
  • MDR has more stringent requirements for demonstrated compliance, vis a visthe obsolete Medical Device Directive (MDD), the previous industry standard.

Teleflex Hosts 2022 Analyst & Investor Day

Retrieved on: 
Friday, May 20, 2022

The live webcast of the 2022 Investor & Analyst Day presentations, including slide presentations, will be available on the Companys website: teleflex.com.

Key Points: 
  • The live webcast of the 2022 Investor & Analyst Day presentations, including slide presentations, will be available on the Companys website: teleflex.com.
  • Teleflex is a global provider of medical technologies designed to improve the health and quality of peoples lives.
  • Teleflex employees worldwide are united in the understanding that what we do every day makes a difference.
  • Teleflex is the home of Arrow, Deknatel, QuikClot, LMA, Pilling, Rsch, UroLift, and Weck trusted brands united by a common sense of purpose.

PHC Receives First EU-MDR Certification, Delivers Motorized Drug Injection Device Enabling More Efficient Patient-Friendly Treatment of Arthritis and Other Inflammatory Conditions

Retrieved on: 
Monday, April 18, 2022

The device, called APP-1000*1, is designed to provide simple, precise, and monitored drug injections in the home setting for conditions including rheumatoid arthritis.

Key Points: 
  • The device, called APP-1000*1, is designed to provide simple, precise, and monitored drug injections in the home setting for conditions including rheumatoid arthritis.
  • APP-1000 is a class IIa*2 portable medical device, manufactured at PHC IVDs Wakimachi plant in Japan.
  • It allows patients to self-inject TNF inhibitors automatically at a touch of a button with no measurement or preparation required.
  • The device comes equipped with an LCD screen with illustrated guidance to make it easier for patients to use.

Impulse Dynamics' Quality Management System Receives Certification Under European Union Medical Device Regulation

Retrieved on: 
Tuesday, March 22, 2022

MARLTON, N.J., March 22, 2022 (GLOBE NEWSWIRE) -- Impulse Dynamics, a company dedicated to innovative treatments for chronic heart failure, is pleased to announce that it has successfully completed the requirements for certification of its quality management system (QMS) under the new Medical Device Regulation (MDR) (EU 2017/745 ) now in force in the European Union (EU).

Key Points: 
  • MARLTON, N.J., March 22, 2022 (GLOBE NEWSWIRE) -- Impulse Dynamics, a company dedicated to innovative treatments for chronic heart failure, is pleased to announce that it has successfully completed the requirements for certification of its quality management system (QMS) under the new Medical Device Regulation (MDR) (EU 2017/745 ) now in force in the European Union (EU).
  • The Medical Device Regulation (EU 2017/45) went into effect in May of 2021 for all manufacturers, distributors, and users of medical devices in the EU, replacing the prior Medical Device Directive and Active Implantable Medical Device Directive.
  • According to Impulse Dynamics CEO, Simos Kedikoglou, M.D., Our ability to achieve certification of our QMS under the MDR affirms Impulse Dynamics position at the leading edge of medical device design, development, and manufacturing.
  • MDR certification opens the door for Impulse Dynamics to proceed with its plans for new product development and to launch them without delay.

Inogen Announces Preliminary, Unaudited Full Year and Fourth Quarter 2021 Revenue Results

Retrieved on: 
Monday, January 10, 2022

Domestic business-to-business sales are expected to be approximately $10.3 million in the fourth quarter of 2021 compared to $24.2 million in the same period in 2020.

Key Points: 
  • Domestic business-to-business sales are expected to be approximately $10.3 million in the fourth quarter of 2021 compared to $24.2 million in the same period in 2020.
  • International business-to-business sales are expected to be approximately $20.1 million in the fourth quarter of 2021 compared to $13.6 million in the comparative period in 2020.
  • Rental revenue in the fourth quarter of 2021 is expected to be approximately $13.0 million compared to $9.4 million in the fourth quarter of 2020.
  • Inogen is in the process of finalizing its results of operations for the year ended December 31, 2021, and therefore, final results are not yet available.