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Global Medical Device News

United States | Combination Products

Applying human factors to nicotine replacement therapy drug products

EMERGO BY UL SUMMARY OF KEY POINTS:

  • US regulators reevaluating how to oversee nicotine replacement therapy (NRT) products;
  • NRT manufacturers should utilize human factors in developing NRT product labels;
  • Self-selection studies recommended for developing NRT product labeling.

Nicotine replacement therapy (NRT) drug products, such as patches, gum and lozenges, have been around for more than 30 years. More novel products such as e-cigarettes provide additional choices for people using NRT for smoking cessation. But, like any other drug...

Source | Stephanie Larsen and Richard Featherstone
Mar 21, 2019
Europe | In-Vitro Diagnostic Devices, Medical Devices

Dutch regulators weigh in on no-deal Brexit impact for medical device companies

Currently Brexit is planned on 29 March 2019, but it is not clear how this process will be executed. One of the realistic outcomes is the ‘no-deal’ Brexit, where the UK leaves without any agreement on how trade and people movements with the EU will be regulated. This means the UK will become a third country from the EU perspective and it is likely not all manufacturers have taken all necessary measures to keep placing devices on the market. All Member States are preparing for this situation. The Dutch authorities have asked Emergo by UL to help in communicating their position,...

Source | Ronald Boumans
Mar 21, 2019
United States | Medical Devices

FDA issues final guidance on devices containing animal-derived materials

EMERGO BY UL SUMMARY OF KEY POINTS:

  • FDA has issued final guidance on medical devices containing animal or animal-derived materials.
  • The guidance supersedes the version issued in 1998 and expands on recommendations in this earlier document.
  • Recommendations in the guidance align with ISO standards series that addresses medical devices containing animal tissue and animal-derived materials.

The US Food and Drug Administration (FDA) issued...

Source | Kate Jablonski
Mar 18, 2019
United States | Medical Devices

Fatal Medical Error: Too common to investigate thoroughly?

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Investigations of preventable medical errors in the US healthcare system in need of revamp;
  • Scale of fatal medical errors hindering more rigorous investigations;
  • Multidisciplinary approach incorporating human factors components needed to address ongoing medical use errors.

On Friday, March 1, 2019, a Tesla automobile was involved in a fatal crash in Palm Beach, Florida. Considering the possibility that the vehicle crash occurred while the vehicle was in autopilot mode, the National Highway Traffic...

Source | Michael Wiklund
Mar 14, 2019
Australia | Medical Devices

Australian medical device regulators preparing Brexit contingency plans

EMERGO BY UL SUMMARY OF KEY POINTS:

  • The Australian TGA has drawn up plans to blunt the impact of Brexit on the country’s medical device market.
  • TGA will continue recognizing conformity assessments from UK-based Notified Bodies for existing and new ARTG listings and applications.
  • Short-term effects of a potential orderly or no-deal Brexit should be minimized by TGA measures as described.

The Australian Therapeutic Goods Administration (TGA) has developed measures to minimize potential negative market impacts of the UK’s Brexit...

Source | Stewart Eisenhart
Mar 13, 2019
Europe | Medical Devices

Increased requirements for clinical evidence under the new Medical Devices Regulation (MDR)

EMERGO BY UL SUMMARY OF KEY POINTS:

  • European MDR clinical data requirements may result in up-classification or recertification of some medical devices.
  • Manufacturers with CE Marked devices should be preparing post-market clinical follow-up (PMCF) studies now in order to comply with MDR requirements in 2020.
  • Meeting the MDR’s PMCF requirements may impact some manufactures’ budgets in unforeseen ways.

The uncertainties about a “No-Deal Brexit” may distract many manufacturers from preparing adequately for the new requirements associated...

Source | Dietmar Falke
Mar 12, 2019
Europe | In-Vitro Diagnostic Devices, Medical Devices

Italian medical device nomenclature to be adapted for Eudamed database

EMERGO BY UL SUMMARY OF KEY POINTS:

  • The European Medical Device Coordination Group (MDCG) plans to use Italy’s CND codes as the basis for the Eudamed device database nomenclature.
  • CND codes will be mapped to Global Medical Device Nomenclature (GMDN) for ease of use.
  • Using CND nomenclature provides public access to medical device codes within Eudamed.

Authorities overseeing implementation of the European Database for Medical Devices (Eudamed) have decided to adapt medical device codes used by the Italian Ministry of Health for use as...

Source | Ronald Boumans and Stewart Eisenhart
Mar 7, 2019
United States | Medical Devices

US, Canadian regulators warn of potential medical device shortages following Sterigenics shutdown

EMERGO BY UL SUMMARY OF KEY POINTS:

  • The shutdown of a Sterigenics medical device sterilization facility in the midwestern US may disrupt supplies of hundreds of devices, according to US FDA and Health Canada.
  • US and Canadian regulators have issues recommendations for manufacturers seeking alternative sterilization sites for their devices.
  • Changing sterilization facility sites may affect manufacturers’ current FDA and/or Health Canada registrations.

Medical device regulators in the US and Canada are both investigating whether the recent...

Source | Stewart Eisenhart
Mar 7, 2019
Brazil | Medical Devices

Brazil's ANVISA launching Notification pathway for low-risk medical devices and IVDs

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Brazilian regulators have published RDC 270/2019 establishing a notification pathway for Class I medical devices and IVDs
  • Qualifying low-risk medical devices will not undergo full ANVISA registration.
  • Implementation of notification pathway set for May 2019.

Brazil’s medical device regulator ANVISA has issued a new regulation for a “notification” market pathway providing streamlined market access for low-risk devices .

ANVISA regulation...

Source | Stewart Eisenhart
Mar 5, 2019
usability testing
Worldwide | Medical Devices

Dealing with usability test no-shows, cancellations, and late participants

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Medical device usability test administrators are often challenged by no-show participants.
  • Steps such as overrecruiting, rescheduling and partial participation allowances can help mitigate this challenge.

It’s 1:25PM, and you’ve just jotted down “P6” – the 1:30PM participant’s unique identifier – at the top of your moderator’s checklist in preparation for your next test session. Five minutes go by, and it’s time for the scheduled session – surely they’ll walk in the door any second now. Another 5 minutes goes...

Source | Rachel Aronchick
Feb 27, 2019