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Global Medical Device News

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 impact up-classified medical devices as well as recertification of some 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...

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
United Kingdom | In-Vitro Diagnostic Devices, Medical Devices

No-deal Brexit: Key Questions for Medical Device Companies

Although questions of when (and even if) Brexit occurs remain open, UK and European markets should be mapping out the impact of a no-deal Brexit on their operations.

Following Emergo by UL’s recent webinar on a no-deal Brexit’s impact on the medical device industry, we discuss some key questions many manufacturers are facing.

How would a no-deal Brexit affect REACH in the UK?

The Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation is part of the EU...

Source | Ronald Boumans
Feb 25, 2019
Australia | Medical Devices

Australian Authorities Consider Adopting European MDR Classification Rules for Spinal Implants

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Australian TGA proposing up-classifying spinal implant devices based on European MDR rules;
  • Targeted devices would move from Class II to Class III under proposed rule;
  • TGA accepting comments on proposed rule until March 31, 2019.

Australian medical device regulators may reclassify some spinal implant devices according to European Medical Devices Regulation (MDR) rules to better reflect these devices’ risk profiles.

The Australian Therapeutic Goods Administration (TGA) has issued a new...

Source | Stewart Eisenhart
Feb 21, 2019
United States | Medical Devices

FDA Proposes More Formalized Form 483 Communications for Medical Devices

EMERGO BY UL SUMMARY OF KEY POINTS:

  • US FDA proposes more transparent process for managing requests for feedback related to Form 483 observations;
  • Requests for feedback to FDA from medical device manufacturers must meet eligibility criteria in order to receive responses;
  • FDA will respond to requests for feedback and proposed corrective actions within 45 days.

The US Food and Drug Administration plans to formalize processes for managing feedback requests received from medical device companies cited for deficiencies following...

Source | Stewart Eisenhart
Feb 20, 2019
Worldwide | Combination Products, In-Vitro Diagnostic Devices, Medical Devices

When the human factors specialist becomes the patient

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Medical devices engineered and designed for clinical end-users often overlook the factor of patient experience.
  • HFE and usability professionals should consider the impact of their designs not just for clinicians but also patients on the receiving end of such devices.
  • Designing devices and systems that better foster positive patient experiences deserves closer attention.

I just had a baby – my second daughter. This means that, like over 98% of my fellow American moms-to-be, I checked into a local...

Source | Allison Strochlic
Feb 14, 2019
India | In-Vitro Diagnostic Devices, Medical Devices

Latest Additions to India CDSCO List of Regulated Medical Devices Include Implantables, CT Scanners

EMERGO SUMMARY OF KEY POINTS:

  • Eight medical device types added to India CDSCO list of regulated devices;
  • Latest batch of devices include implantable devices, CT scanners and MRI equipment;
  • These devices will have to be registered with CDSCO by April 1, 2020.

India’s Central Drugs Standard Control Organization (CDSCO) continues expanding oversight to more types of medical devices, now planning to require registration for eight additional device types starting April 1, 2020.

According to a new CDSCO...

Source | Stewart Eisenhart
Feb 14, 2019