Regulation (EU) 2017/746

Navigating through Maze of In-Vitro Diagnostics (IVD) Regulations: A Systematic Approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada (September 16-17, 2021) - ResearchAndMarkets.com

Retrieved on: 
Monday, July 26, 2021
Medical devices, Health, IVD, Regulation (EU) 2017/746, In vitro, Science

The "Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada" training 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" training has been added to ResearchAndMarkets.com's offering.
  • In-vitro Diagnostics (IVD) products provide critical information on patient's health condition, based on which the healthcare provider develops and administers treatment plan.
  • This 2-day interactive course on in-vitro diagnostics is structured to understand the different set 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.

Irdeto partners with confinis to launch the first cybersecurity assessment tool in the medical devices industry

Retrieved on: 
Tuesday, July 6, 2021
Regulation (EU) 2017/746, Data security, Medical device, Regulation (EU) 2017/745, Cyberwarfare, Technology, Computer security, Medtech, Articles, Common specifications

As part of the partnership, Irdeto and confinis will launch a web-based assessment tool enabling medical device providers to examine their cybersecurity and regulatory preparedness under the European Medical Device Regulation (MDR) and the European In Vitro Diagnostic Medical Device Regulation (IVDR).

Key Points: 
  • As part of the partnership, Irdeto and confinis will launch a web-based assessment tool enabling medical device providers to examine their cybersecurity and regulatory preparedness under the European Medical Device Regulation (MDR) and the European In Vitro Diagnostic Medical Device Regulation (IVDR).
  • Protection of connected medical devices as well as the information of providers and patients that use them is essential.
  • Together, we are making the medical devices industry stronger and protecting patients from cyberattacks that could negatively affect their health and wellbeing."
  • "The combined expertise of confinis and Irdeto will bring unparalleled cybersecurity and regulatory capabilities to medtech customers.

Fix Price Group Ltd. : Notification of PDMR transaction

Retrieved on: 
Thursday, June 17, 2021
Articles, Conflict of interest, Corruption, Information, Insider trading, Stock market, Regulation (EU) 2017/746

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.

Fix Price Group Ltd. : Notification of PDMR transaction

Retrieved on: 
Wednesday, June 16, 2021
Articles, Conflict of interest, Corruption, Information, Insider trading, Stock market, Regulation (EU) 2017/746

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, June 16, 2021
Articles, Conflict of interest, Corruption, Information, Insider trading, Stock market, Regulation (EU) 2017/746

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.

Fix Price Group Ltd. : Notification of PDMR transaction

Retrieved on: 
Tuesday, June 15, 2021
Articles, Conflict of interest, Corruption, Information, Insider trading, Stock market, Regulation (EU) 2017/746

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.

Fix Price Group Ltd. : Notification of PDMR transaction

Retrieved on: 
Tuesday, June 15, 2021
Articles, Conflict of interest, Corruption, Information, Insider trading, Stock market, Regulation (EU) 2017/746

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.

Fix Price Group Ltd. : Notification of PDMR transaction

Retrieved on: 
Thursday, June 10, 2021
Articles, Conflict of interest, Corruption, Information, Insider trading, Stock market, Regulation (EU) 2017/746

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: 
Thursday, June 10, 2021
Articles, Conflict of interest, Corruption, Information, Insider trading, Stock market, Regulation (EU) 2017/746

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.

DEARhealth becomes one of the world's first companies to obtain CE-marking according to new European Union Medical Device Regulation (MDR)

Retrieved on: 
Wednesday, June 9, 2021
Regulation, Articles, Medical device, Quality management, Regulation (EU) 2017/745, Medical software, Evaluation, Conformance testing, Regulation (EU) 2017/746, Regulation (EU) No. 305/2011, MDR, Quality management system

The CE-mark allows DEARhealth to market its medical software commercially in the European Union.

Key Points: 
  • The CE-mark allows DEARhealth to market its medical software commercially in the European Union.
  • CE-marking according to MDR assures health systems and pharmaceutical companies that a software as a medical device complies to European Union regulation and meets a high standard of quality and safety requirements.
  • "Our partnersin both the US and Europecan be confident that we design and manufacture our medical device software under high standards of quality and safety.
  • Following a successful conformity assessment, including an audit of the quality management system, DEARhealth is among the first 250 manufacturers to obtain CE-marking according to MDR for their medical device software.