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Global Medical Device News

Europe | Medical Devices

Investigational site and personnel selection for medical device clinical studies

EMERGO BY UL SUMMARY OF KEY POINTS:

  • European MDR requirements will affect criteria for medical device clinical study investigators and sites;
  • Fewer clinicians will qualify as pre-clinical study investigators under the MDR;
  • PMCF study sponsors and investigators should not underestimate requirements and obligations;
  • In-person facility inspections and personnel interviews should be conducted to mitigate risks and determine proper clinical study support.

With the requirement in the new European Medical Devices Regulation (MDR) to...

Source | Dietmar Falke
Apr 16, 2019
United States | Medical Devices

US FDA issues finalized list of Class I medical device accessories

EMERGO BY UL SUMMARY OF KEY POINTS:

  • FDA finalizes Class I classification for some medical device accessories;
  • Class I designations take effect May 13, 2019;
  • Additional accessories may be identified for low-risk classification by 2024.

The US Food and Drug Administration has published a finalized list of accessories to be designated as low-risk Class I medical devices in accordance with the FDA Reauthorization Act of 2017 (FDARA).

FDA’s...

Source | Stewart Eisenhart
Apr 15, 2019
Egypt | Medical Devices

Egypt’s fast-track medical device registration pathway reducing market access timeframes

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Egypt’s fast-track medical device registration pathway reduces CAPA premarket review timeframes to three months;
  • Fast-track review is available for sterile and non-sterile disposable devices.

A fast-track premarket review pathway for some medical devices in Egypt is yielding substantially reduced time to market for qualifying manufacturers.

According to Emergo by UL consultants in Cairo, the Egyptian Central Administration of Pharmaceutical Affairs (CAPA)’s...

Source | Stewart Eisenhart
Apr 11, 2019
UK requests further extension on Brexit
Europe | In-Vitro Diagnostic Devices, Medical Devices

UK requests another Brexit deadline extension, furthering market uncertainties

EMERGO SUMMARY OF KEY POINTS:

  • The British Prime Minister has asked to have Brexit Day moved again;
  • It is far from certain the EU will allow for another extension;
  • Theresa May asks for more time to negotiate with the British Parliament on how to leave the EU;
  • This delay implies that the UK will take part in the elections for the European Parliament.

The UK government has requested a further delay in implementing its withdrawal from the European Union, with an April 12 deadline for a no-deal Brexit outcome fast approaching....

Source | Ronald Boumans
Apr 8, 2019
Canada | Medical Devices

Health Canada clarifies “significant change” qualifications to Medical Device Licenses following Sterigenix shutdown

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Health Canada clarifies which changes in sterilization processes would require Medical Device License amendment applications;
  • Impact of Sterigenics sterilization facility in the US on MDL holders still being assessed.

Canadian medical device regulator Health Canada has issued a clarification on which changes to Medical Device License (MDL) holders’ sterilization processes constitute “significant changes” following the closure of a major sterilization facility in the US earlier in 2019.

In a recent...

Source | Stewart Eisenhart
Apr 5, 2019
Worldwide | Medical Devices

Top 5 issues for medical device risk management and design controls

EMERGO BY UL SUMMARY OF KEY POINTS:

  • A medical device’s design controls should be tied closely to risk/benefit analyses specific to that device per ISO 14971;
  • End-equipment manufacturers that utilize third-party suppliers are still ultimately responsible for quality and risk management requirements for their devices;
  • Risk scales should be tailored to the characteristics of specific devices in order to improve reliability.

Medical device design and development processes in the context of risk management require careful consideration and...

Source | Mark Leimbeck
Apr 4, 2019
United States | Medical Devices

US FDA identifies hundreds of device types affected by sterilization facility closures

EMERGO BY UL SUMMARY OF KEY POINTS:

  • US FDA identifies more than 600 medical device types potentially impacted by closures of two sterilization facilities;
  • FDA has launched a notification system whereby device manufacturers and users may notify the agency of any shortages or related supply issues stemming from sterilization facility shutdowns.
  • Facility closures demonstrate the need for developing new and improved sterilization methods for devices.

The US Food and Drug Administration has identified nearly 600 types of medical devices...

Source | Stewart Eisenhart
Apr 3, 2019
Japan | Medical Devices

Japanese regulators increase medical device registration fees for 2019

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Japan’s PMDA has increased medical device registration fees as of Aprill 1, 2019.
  • Any Japanese market registration received after March 29, 2019 will be subject to the new fees.

Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has increased registration, inspection and related regulatory fees for medical device market applicants.

The new fees have taken effect as of April 1, 2019 (link in Japanese). PMDA has issued three...

Source | Stewart Eisenhart
Apr 1, 2019
United States |

Latest insights on FDA expectations from the HFES Health Care Symposium

EMERGO BY UL SUMMARY OF KEY POINTS:

  • FDA reviewers emphasized the need for “usable” human factors documentation in premarket submissions at recent Human Factors and Ergonomics Society symposium;
  • Thorough utilization of use-related risk analysis becoming more important, according to FDA.
  • FDA officials recommend that manufacturers reduce use-related risks in their devices and stay current with post-market surveillance requirements.

Manufacturers, consultants, researchers, and regulators all descended upon Chicago this week for the annual...

Source | Erin Davis and Allison Strochlic
Apr 1, 2019
Worldwide |

GDPR and human factors studies for medical devices: Key issues for manufacturers and sponsors

EMERGO BY UL SUMMARY OF KEY POINTS:

  • The European GDPR has ramifications for how medical device human factors researchers collect and manage data related to study participants, even outside of the EU.
  • Human factors researchers should work with their clients (if they serve in a consulting capacity) and other third parties (e.g., vendors) to define roles and responsibilities early during study planning and develop best practices that comply with GDPR requirements.
  • All participant data management decisions and rationales should be properly documented to
  • ...
Source | Stewart Eisenhart
Apr 1, 2019