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Global Medical Device News

Europe | Medical Devices

KPMG and RAPS: Medical Device Companies Under-prepared for European MDR

EMERGO SUMMARY OF KEY POINTS:

  • A new medical device industry survey finds many firms still lack a firm understanding of the European Medical Devices Regulation (MDR) and related compliance issues.
  • Device manufacturers cite lack of understanding of the MDR as well as shrinking Notified Body capacity as top challenges ahead of the Regulation’s 2020 enforcement deadline.
  • Survey conductors provide several recommendations for manufacturers to more fully prepare for MDR compliance.

A new medical device industry survey shows that many medical...

Source | Stewart Eisenhart
Oct 10, 2018
China | Medical Devices

Chinese Regulators Continue Adding Medical Devices, IVDs to Clinical Trial Exemption List

EMERGO SUMMARY OF KEY POINTS:

  • China’s National Medical Products Administration (NMPA) has expanded its list of medical devices and IVDs exempt from clinical trial requirements for the second time in 2018.
  • NMPA now exempts more than 1,200 products from clinical trial requirements in China.

China’s National Medical Products Administration (NMPA), formerly known as the China Food and Drug Administration, has added more medical device and IVD product types to its list of products exempt from clinical trial requirements in the country.

...

Source | Stewart Eisenhart
Oct 8, 2018
Worldwide | Medical Devices

ISO 14155 Update in 2019: Key Changes for Medical Device Clinical Investigations

EMERGO by UL SUMMARY OF KEY POINTS:

  • The third edition of the ISO 14155 standard for medical device clinical investigations is expected in 2019.
  • Broader risk management requirements are a key feature of the revised ISO 14155.
  • Final publication of ISO 14155’s third edition will likely occur in mid-2019.

Revisions to the ISO 14155 standard covering pre- and post-market clinical investigations for medical devices are set to take effect in 2019. Manufacturers and clinical trial sponsors should consider ramifications of the updated standard...

Source | Dietmar Falke Aleksandra Klimaszewski and Stewart Eisenhart
Oct 8, 2018
United States | Medical Devices

US FDA’s Medical Device Division Lays Out Regulatory Guidance Plans for 2019

EMERGO SUMMARY OF KEY POINTS:

  • US FDA’s medical device oversight division identifies key guidance publication plans for 2019.
  • Top FDA Center for Devices and Radiological Health (CDRH) guidance topics for 2019 include cybersecurity, Least Burdensome Provisions and Unique Device Identification (UDI) implementation and compliance issues.
  • Lower-priority CDRH guidance documents may also see publication in 2019 if resources permit.

Updated cybersecurity requirements for medical device premarket submissions, Abbreviated and Special 510(k)...

Source | Stewart Eisenhart
Oct 3, 2018
United States | Medical Devices

US FDA Launches Pilot to Expand Special 510(k) Market Pathway

EMERGO SUMMARY OF KEY POINTS:

  • US FDA launching pilot program to expand Special 510(k) route for modifications to medical devices.
  • Pilot would allow more types of device changes to qualify for simplified Special 510(k) route.
  • All Special 510(k) submissions received by FDA from October 1, 2018 will be considered for participation in pilot.

Medical device regulators at the US Food and Drug Administration has initiated a new pilot program for expanded eligibility in the agency’s Special 510(k) pathway, potentially easing market compliance...

Source | Stewart Eisenhart
Oct 3, 2018
Europe | Medical Devices

Effects of “No Deal” Brexit for Medical Device Sector

EMERGO SUMMARY OF KEY POINTS:

  • A “no deal” or “Cliff Edge” Brexit is a realistic scenario, becoming more realistic every day.
  • The UK government issued documents about preparing for this Cliff Edge scenario.
  • This scenario can affect companies all over the world, as they may depend on certificates issued by UK-based Notified Bodies or use a UK-based Authorized Representative (AR).
  • Companies using a UK-based AR and UK-based companies exporting to the EU will need an EU-based AR.
  • It is likely an AR is also required for non-UK companies placing
  • ...
Source | Ronald Boumans
Sep 26, 2018
India | Medical Devices

India Medical Device and IVD Regulatory Update: September 2018

EMERGO SUMMARY OF KEY POINTS:

  • India’s Central Drugs Standard Control Organization (CDSCO) plans to rename itself.
  • CDSCO has also published new guidance documents on Medical Device Regulations, 2017 compliance and performance evaluations for IVDs.

Indian regulators have recently announced several updates regarding their medical device and IVD oversight programs.

CDSCO renaming

First, CDSCO plans to rename itself to more accurately convey its...

Source | Stewart Eisenhart
Sep 21, 2018
United States | Medical Devices

US Regulators Update Policies for Medical Device Voluntary Consensus Standards

EMERGO SUMMARY OF KEY POINTS:

  • US FDA draft guidance explains agency’s process for recognizing voluntary consensus standards used for medical device declarations of conformity.
  • The guidance describes FDA’s process and criteria for determining complete or partial recognition or non-recognition of consensus standards.

The US Food and Drug Administration’s medical device regulatory division has issued new guidance clarifying how it recognizes and withdraws voluntary consensus standards.

FDA’s Center for Devices and Radiological Health (CDRH...

Source | Stewart Eisenhart
Sep 20, 2018
United States |

US Regulators Plan Overhaul of Third-Party 510(k) Review Program

EMERGO SUMMARY OF KEY POINTS:

  • US FDA is amending its 510(k) third-party review program 3PRO to reduce the need for agency re-reviews of these submissions and market entry delays.
  • As part of the 3PRO overhaul, FDA will adjust its list of eligible devices to focus more on lower-risk, less complex products.
  • By 2021, FDA wants 85% of 3PRO-reviewed 510(k) submissions to go through without the need for agency re-review.

The US Food and Drug Administration has set a goal of obviating the need to re-review 85% or more of 510(k) applications...

Source | Stewart Eisenhart
Sep 17, 2018
United States | Medical Devices

US FDA Proposes Single, Electronic Submissions for Medical Device Market Applicants

EMERGO SUMMARY OF KEY POINTS:

  • US FDA wants only electronic submissions for most medical device premarket applications.
  • US regulators currently require both paper and electronic copies of 510(k) and other premarket submissions.
  • FDA will accept both eCopy and eSubmission formats as qualified electronic submissions.

Medical device regulators at the US Food and Drug Administration intend to eliminate requirements for paper and multiple copies of premarket applications in favor of single electronic submissions for agency review.

The...

Source | Stewart Eisenhart
Sep 13, 2018