Regulation (EU) 2017/746

SciBase receives important European MDR certification

Retrieved on: 
Monday, May 10, 2021

SciBase is one of very few medical device manufacturers to have completed the MDR certification, after an intensive two year process.

Key Points: 
  • SciBase is one of very few medical device manufacturers to have completed the MDR certification, after an intensive two year process.
  • With the MDR Certification in place SciBase can release new products, indications and functionality such as their new Non-melanoma Skin cancer (NMSC) application.\nThe MDR was introduced by the European Union to establish a modernized and more robust legislative framework for medical devices.
  • The result is the MDR industry regulations.\nMDR tightens the control mechanisms for medical devices, including medical software and Apps and will have substantial impact on medical device manufacturers and distributors.\n"Achieving MDR has been a strategically important goal for SciBase, because MDR is necessary for us to add new applications such as NMSC (Non-Melanoma Skin Cancer) to our platform which is key to our strategy.For customers this will result in better products.
  • I believe many companies will struggle to achieve certification and so we believe MDR certification will be a competitive advantage going forward.

Almost Three-quarters of Medical Device Companies Ready to Meet the European Union’s MDR and IVDR Regulations, According to RWS Research

Retrieved on: 
Monday, May 10, 2021

b'A research report from RWS, the world\xe2\x80\x99s leading provider of technology-enabled language, content management and intellectual property services, highlights the impact of COVID-19 on medical device manufacturers, and their readiness to meet the European Union\xe2\x80\x99s (EU) Medical Device regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) deadline.\nThe research, involving leading medical device organizations operating in Europe, looks at how the pandemic has affected their preparations to meet the 26 May 2021 deadline for the EU MDR, and EU IVDR deadline of 26 May 2022.

Key Points: 
  • b'A research report from RWS, the world\xe2\x80\x99s leading provider of technology-enabled language, content management and intellectual property services, highlights the impact of COVID-19 on medical device manufacturers, and their readiness to meet the European Union\xe2\x80\x99s (EU) Medical Device regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) deadline.\nThe research, involving leading medical device organizations operating in Europe, looks at how the pandemic has affected their preparations to meet the 26 May 2021 deadline for the EU MDR, and EU IVDR deadline of 26 May 2022.
  • \xe2\x80\x9cThe decisions that medical manufacturing organizations make now won\xe2\x80\x99t just affect their ability to comply with these two regulations, they will also play a continuing role in how quickly and effectively they can meet compliance standards in years to come.
  • It will also help with compliance and vendor management.\nAudit the current software and data environment to ensure it enables compliance with these regulations.
  • Full details of the EU MDR and IVDR can be found at https://ec.europa.eu/health/md_sector/overview_en .\nThis research was conducted by WBR Insights and draws insights directly from members of the medical device and in vitro diagnostics industry who operate in the EU.

Worldwide Medical Device Testing Industry to 2027 - by Service, Technology, Device Class and Geography - ResearchAndMarkets.com

Retrieved on: 
Friday, April 30, 2021

b'The "Medical Device Testing Market by Service Type (Testing and Certification) Location, Technology (Active Implant, Active Medical, In-Vitro Diagnostic, Ophthalmic, Orthopedic and Dental, Vascular), Device Class, and Geography - Global Forecast to 2027" report has been added to ResearchAndMarkets.com\'s offering.\nThis report provides in-depth analysis of the medical device testing market in five major geographies and emphasizes on the current market trends, market size, market share, recent developments, and forecast till 2027.\nThe medical device testing market is expected to reach $12.5 billion by 2027, growing at a CAGR of 4.7% during the forecast period of 2019 to 2027.

Key Points: 
  • b'The "Medical Device Testing Market by Service Type (Testing and Certification) Location, Technology (Active Implant, Active Medical, In-Vitro Diagnostic, Ophthalmic, Orthopedic and Dental, Vascular), Device Class, and Geography - Global Forecast to 2027" report has been added to ResearchAndMarkets.com\'s offering.\nThis report provides in-depth analysis of the medical device testing market in five major geographies and emphasizes on the current market trends, market size, market share, recent developments, and forecast till 2027.\nThe medical device testing market is expected to reach $12.5 billion by 2027, growing at a CAGR of 4.7% during the forecast period of 2019 to 2027.
  • The growth in this market is mainly driven by the increasing need for the validation and verification of medical devices and stringent government regulations and standards across medical devices and medical device technologies.
  • However, dynamic regulations/standards across regions and lack of testing facilities and skilled resources can obstruct the growth of this market.\nThe study offers a comprehensive analysis of the medical device testing market with respect to service type, sourcing type, technology, device class, and geography.
  • The medical device testing market is segmented by service type (testing, (physical testing, (electrical safety testing, functional safety testing, EMC testing, environmental testing, and others), chemical/biological testing and cybersecurity testing (biological evaluation & biocompatibility testing, biological, physical, & chemical testing)) & certification) sourcing type (in-house and outsourced), technology (active implant medical device, active medical device, non-active medical device, in-vitro diagnostic medical device, ophthalmic medical device, orthopedic and dental medical device, vascular medical device, and other), device class (class-1, class-2, & class-3), and region The study also evaluates industry competitors and analyses the market at the country level.\n'

Global $11.8 Billion Medical Device Testing Market to 2025 with SGS, Eurofins Scientific, Bureau Veritas, Intertek, TUV SUD, and DEKRA Dominating

Retrieved on: 
Tuesday, April 13, 2021

b'DUBLIN, April 13, 2021 /PRNewswire/ -- The "Medical Device Testing Market with COVID-19 Impact, By Services (Testing, Inspection, Certification), Sourcing, Technology (Active Implant, IVD, Orthopedic & Dental, Opthalmic, Vascular), Class, Testing, Region - Global Forecast to 2025" report has been added to ResearchAndMarkets.com\'s offering.\nThe Medical Device Testing Market Was Valued at USD 9.3 Billion in 2020 and is Projected to Reach USD 11.8 Billion by 2025; Growing at a CAGR of 4.8% from 2020 to 2025.\nThe market for medical device testing is primarily driven by the continuously rising number of COVID-19 cases leading to the increasing number of ICU beds, which leads to the growing demand for COVID-19 priority medical devices.\nThe market is also driven by factors such as the increased requirement for PPE kits and N95 masks globally and rising demand for ventilators for the effective management of critical COVID-19 patients.\nThe demand for in-vitro diagnostic products due to the COVID-19 pandemic is expected to increase mainly due to factors such as market demand for rapid-test products and a sharp rise in the target patient population in a few countries.\nThe harmonization of standards, growing consumption of medical devices in emerging countries, increasing need of validation and verification for medical devices, the imposition of rigorous government regulations, the growing trend of outsourcing medical device testing services and standards across medical devices will drive the growth of medical device testing market.\nThe medical device testing market is growing due to the increasing need of verification and validation for medical devices.

Key Points: 
  • b'DUBLIN, April 13, 2021 /PRNewswire/ -- The "Medical Device Testing Market with COVID-19 Impact, By Services (Testing, Inspection, Certification), Sourcing, Technology (Active Implant, IVD, Orthopedic & Dental, Opthalmic, Vascular), Class, Testing, Region - Global Forecast to 2025" report has been added to ResearchAndMarkets.com\'s offering.\nThe Medical Device Testing Market Was Valued at USD 9.3 Billion in 2020 and is Projected to Reach USD 11.8 Billion by 2025; Growing at a CAGR of 4.8% from 2020 to 2025.\nThe market for medical device testing is primarily driven by the continuously rising number of COVID-19 cases leading to the increasing number of ICU beds, which leads to the growing demand for COVID-19 priority medical devices.\nThe market is also driven by factors such as the increased requirement for PPE kits and N95 masks globally and rising demand for ventilators for the effective management of critical COVID-19 patients.\nThe demand for in-vitro diagnostic products due to the COVID-19 pandemic is expected to increase mainly due to factors such as market demand for rapid-test products and a sharp rise in the target patient population in a few countries.\nThe harmonization of standards, growing consumption of medical devices in emerging countries, increasing need of validation and verification for medical devices, the imposition of rigorous government regulations, the growing trend of outsourcing medical device testing services and standards across medical devices will drive the growth of medical device testing market.\nThe medical device testing market is growing due to the increasing need of verification and validation for medical devices.
  • The in-vitro diagnostic (IVD) medical device segment held the largest share of the medical device testing market in 2019, owing to the increasing demand for rapid testing kits and other diagnostics devices across regions.\nThe active implant medical device segment is projected to witness the highest CAGR during the forecast period, owing to the implementation of stringent regulations to ensure that the implantable medical devices are fit for the human body.\nTesting services are likely to hold the largest share of the medical device testing market, in terms of value, in 2025 and a similar trend is expected to continue until 2025\nThe medical device testing market for certification services is projected to grow at the highest CAGR during the forecast period.
  • Certification services are required to check whether the medical devices and services have complied with the required standards and regulations.\nThere has been a high surge in demand for class III devices since they include life-critical medical devices that are needed in treating COVID-19 patients also these devices have to go through critical testing, inspection, and certification processes.\nAsia Pacific: The fastest-growing region in the medical device testing market.\nThe Asia Pacific region is estimated to dominate the medical device testing market and is projected to grow at the highest CAGR during the forecast period.
  • The market growth in this region can be attributed to the increase in regulatory focus on quality control for manufacturing operations and additional safety, testing, and reporting measures, which require advanced test equipment and instrumentation on-site in manufacturing facilities and laboratories.\n'

Online Seminar: Navigating through Maze of In-vitro Diagnostics (IVD) Regulations - A Systematic Approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada, March 11th-12th, 2021 - ResearchAndMarkets.com

Retrieved on: 
Monday, March 1, 2021

The "Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada" conference has been added to ResearchAndMarkets.com's offering.
  • Although IVDs are medical devices, they are regulated under a separate set of regulations in the U.S., Europe, and Canada.
  • This 2-day interactive course on in-vitro diagnostics is structured to understand the different sets of IVD regulations, how to navigate through this maze of IVD regulations, and to win regulatory approvals.
  • This In-vitro Diagnostics (IVD ) course will make the attendees understand the IVD regulations and develop regulatory strategies that secure regulatory approvals.

SThree: Director/PDMR Shareholding

Retrieved on: 
Wednesday, February 17, 2021

Dissemination of a Regulatory Announcement that contains inside information according to REGULATION (EU) No 596/2014 (MAR), transmitted by EQS Group.

Key Points: 

Dissemination of a Regulatory Announcement that contains inside information according to REGULATION (EU) No 596/2014 (MAR), transmitted by EQS Group.
The issuer is solely responsible for the content of this announcement.

SThree: Director/PDMR Shareholding

Retrieved on: 
Wednesday, February 17, 2021

Dissemination of a Regulatory Announcement that contains inside information according to REGULATION (EU) No 596/2014 (MAR), transmitted by EQS Group.

Key Points: 

Dissemination of a Regulatory Announcement that contains inside information according to REGULATION (EU) No 596/2014 (MAR), transmitted by EQS Group.
The issuer is solely responsible for the content of this announcement.