Medical Devices Directive

ESAOTE completed the transition of its medical devices to the MDR-Medical Devices Regulation much ahead of the expiry of MDD-Medical Devices Directive 93/42/EEC certificates

Retrieved on: 
Tuesday, December 13, 2022
Quality management system, Medical Devices Directive, Software, EC, MRI, SD, Medical device, MDR, Safety, Magnetic resonance imaging, MDD, EU, Esaote

In 2022, ESAOTE boasts 25 ultrasound medical devices and 2 MRI medical devices, all certified under the new MDR CE Mark, issued by TV SD, and by the end of 2022 all ESAOTE ultrasound medical devices will switch to production under the MDR CE Mark.

Key Points: 
  • In 2022, ESAOTE boasts 25 ultrasound medical devices and 2 MRI medical devices, all certified under the new MDR CE Mark, issued by TV SD, and by the end of 2022 all ESAOTE ultrasound medical devices will switch to production under the MDR CE Mark.
  • "At Esaote, we have created a dedicated company-wide, interdepartmental project team to complete the transition of all our medical devices from the MDD to the MDR in the most efficient way," said Franco Fontana, CEO of Esaote.
  • "Our Quality Management System team has driven all the actions towards this new regulation, which focuses on quality and safety, significantly improving the regulatory rules for medical devices to be sold in Europe."
  • At the end of 2021, the Group had 1,280 employees, more than half of whom were in Italy.

Lunit Becomes the First Medical Software Company in Asia-Pacific to Become MDR CE and UKCA Certified

Retrieved on: 
Monday, November 21, 2022
Medical device regulation, Indian Radio Regulatory Service, Medical Devices Directive, JAMA Network Open, MDR, Journal, MMG, Therapy, KRX, Radiology, Pulmonary fibrosis, MDD, FDA, Breast cancer, IBM, ASCO, Accreditation, Multimedia, Death, CE marking, AACR, Certification, CE, UKCA, American Journal of Clinical Oncology, Hospital, Tuberculosis, Microsoft, Pneumothorax, Medical device, BSI, AI, Biomarker, European

The Lunit INSIGHT product line also received the UK Conformity Assessed (UKCA) marking, obtaining commercial approval across both the UK and Europe.

Key Points: 
  • The Lunit INSIGHT product line also received the UK Conformity Assessed (UKCA) marking, obtaining commercial approval across both the UK and Europe.
  • With these two markings, Lunit has become the first software as a medical device (SaMD) company in the Asia Pacific region to earn such accreditation.
  • Among the Lunit INSIGHT suite, two products received the MDR CE and UKCA certifications: Lunit INSIGHT CXR, an AI solution for chest x-ray analysis, and Lunit INSIGHT MMG, an AI solution for mammography analysis.
  • "Our MDR CE and UKCA certifications clearly show Lunit's high product power and advanced regulatory compliance capabilities," remarked Brandon Suh, CEO of Lunit.

Lunit Becomes the First Medical Software Company in Asia-Pacific to Become MDR CE and UKCA Certified

Retrieved on: 
Monday, November 21, 2022
Medical device regulation, Indian Radio Regulatory Service, Medical Devices Directive, JAMA Network Open, MDR, Journal, MMG, Therapy, KRX, Radiology, Pulmonary fibrosis, MDD, FDA, Breast cancer, IBM, ASCO, Accreditation, Multimedia, Death, CE marking, AACR, Certification, CE, UKCA, American Journal of Clinical Oncology, Hospital, Tuberculosis, Microsoft, Pneumothorax, Medical device, BSI, AI, Biomarker, European

The Lunit INSIGHT product line also received the UK Conformity Assessed (UKCA) marking, obtaining commercial approval across both the UK and Europe.

Key Points: 
  • The Lunit INSIGHT product line also received the UK Conformity Assessed (UKCA) marking, obtaining commercial approval across both the UK and Europe.
  • With these two markings, Lunit has become the first software as a medical device (SaMD) company in the Asia Pacific region to earn such accreditation.
  • Among the Lunit INSIGHT suite, two products received the MDR CE and UKCA certifications: Lunit INSIGHT CXR, an AI solution for chest x-ray analysis, and Lunit INSIGHT MMG, an AI solution for mammography analysis.
  • "Our MDR CE and UKCA certifications clearly show Lunit's high product power and advanced regulatory compliance capabilities," remarked Brandon Suh, CEO of Lunit.

Bioretec updates its estimate of the timing for approval of the CE mark for the RemeOs™ trauma screw

Retrieved on: 
Friday, November 4, 2022
EET, Medical Devices Directive, Health care, Notified body, Time, CE, MedTech Europe, MDR, Certification, Bone, Trauma, Patient, CEO, MDD, Union, Workload, Directive, Medical Device Regulation Act, Medical device, EU

TAMPERE, Finland, Nov. 4, 2022 /PRNewswire/ -- Bioretec Ltd, a pioneer in biodegradable orthopedic implants, expects the European marketing authorization for the RemeOs™ trauma screw to be delayed from the original estimate of 2022. The company estimates, based on the stage of its own registration process and the latest reports on certifications in the healthcare industry, that obtaining a market authorization will move to 2023. The review process of the CE mark application is ongoing, and the company is still waiting for the feedback from the Notified Body on main sections of the submitted application. The company will disclose further information as soon as more details of the schedule for the market authorization will be available.

Key Points: 
  • The company will disclose further information as soon as more details of the schedule for the market authorization will be available.
  • Bioretec submitted the CE mark application for the European market authorization at the end of 2021.
  • In the European Union, the CE mark applications are handled by Notified Bodies.
  • Due to the reasons mentioned, we consider it to be unlikely that the CE mark would be approved during 2022.

Bioretec updates its estimate of the timing for approval of the CE mark for the RemeOs™ trauma screw

Retrieved on: 
Friday, November 4, 2022
EET, Medical Devices Directive, Health care, Notified body, Time, CE, MedTech Europe, MDR, Certification, Bone, Trauma, Patient, CEO, MDD, Union, Workload, Directive, Medical Device Regulation Act, Medical device, EU

TAMPERE, Finland, Nov. 4, 2022 /PRNewswire/ -- Bioretec Ltd, a pioneer in biodegradable orthopedic implants, expects the European marketing authorization for the RemeOs™ trauma screw to be delayed from the original estimate of 2022. The company estimates, based on the stage of its own registration process and the latest reports on certifications in the healthcare industry, that obtaining a market authorization will move to 2023. The review process of the CE mark application is ongoing, and the company is still waiting for the feedback from the Notified Body on main sections of the submitted application. The company will disclose further information as soon as more details of the schedule for the market authorization will be available.

Key Points: 
  • The company will disclose further information as soon as more details of the schedule for the market authorization will be available.
  • Bioretec submitted the CE mark application for the European market authorization at the end of 2021.
  • In the European Union, the CE mark applications are handled by Notified Bodies.
  • Due to the reasons mentioned, we consider it to be unlikely that the CE mark would be approved during 2022.

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
Cortex, Adult, MDR, National Association of Epilepsy Centers, Safety, Movement, Seizure, Department, Medical device regulation, Brain, FDA, TDCS, MDD, Thalamus, University Medical Center Freiburg, Clinical study design, Electrode, Medical Devices Directive, The New England Journal of Medicine, Certification, Patient, Epilepsy, Environment, FCS, CE, Quality of life, CTO, Psychology, Neuro, Scalp, Food, Medical device, Disease, Trial of the century, Freedom, Medicine, DEPT, Pharmaceutical industry, Wood drying, MD

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
MDR, Health, Safety, MDD, Intention, Medtech, IOL, Compliance, Knife, Partnership, Patient, Medical Devices Directive, Certification, CEO, European Medical Writers Association, Solution, EC, Surgeon, Quality assurance, GLOBE, Notified body, Product life-cycle theory, BSI, Medical device, Business operations, Nasal cannula, EU, BVI

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
Medical device regulation, QMS, Quality assurance, Safety, CEO, Solution, Documentation, Temperature, Esophagus, Medical Devices Directive, Physician, LinkedIn, BSI Group, Medical device, Compliance, EP, Certification, Twitter, MDD, Quality management system, MDR, Perfume, EU

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
Health, Medical Devices, Cardiology, MDD, Freedom, Union, Vascular disease, Patient, PAD, AFX, AAA, Quality, Safety, European Commission, Moyamoya disease, Medical Devices Directive, Randomized controlled trial, Technology, Aortic aneurysm, Aneurysm, Forward-looking statement, CEO, Certification, EVAR, Royal commission, Medical device, Acquisition, MDR, EU

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
ISO, Anesthesia, CPR, FL, Medical device, EC, ISO 9001, CEO, MDSAP, Royal commission, EMS, MDR, Adult, MDD, Regulation, Resuscitation, Medical Devices Directive, Certification, HUGE, European Commission, Mercury, EU

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.