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Global Medical Device News

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
Worldwide | Medical Devices

The Role of Good Clinical Practices (GCP) in Medical Device Clinical Investigations

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Good Clinical Practice (GCP) must be adhered to by medical device companies conducting clinical investigations for their products.
  • GCP requirements make exceptions for software as a medical device (SaMD) for which some developers may qualify.
  • Besides GCP, additional standards such as ISO 14155 may apply to clinical studies for medical devices.

Medical device manufacturers should ensure compliance to Good Clinical Practice (GCP) as they undertake clinical investigations to meet regulatory requirements...

Source | Aleksandra Klimaszewski and Stewart Eisenhart
Feb 14, 2019
Electronic Instructions for Use (eIFUs)
India | Medical Devices

Potential Advantages and Disadvantages of Electronic Instructions for Use (eIFUs) for Medical Devices

EMERGO BY UL SUMMARY OF KEY POINTS:

  • India has become the latest medical device market whereby regulators have begun accepting electronic indications for use (eIFU) for registrations.
  • Manufacturers can realize advantages of utilizing eIFU, but should consider how eIFU may impact other design, labeling and user interface issues.
  • Markets including the US and European Union already recognize eIFU for medical device premarket submissions.

Recently, the Indian Ministry of Health & Family Welfare granted that instructions for use (IFU)...

Source | Michael Wiklund
Feb 6, 2019
Europe | In-Vitro Diagnostic Devices, Medical Devices, Procurement/Supply Chain

European Commission Requirements for Marketing Medical Devices in a No-deal Brexit Scenario

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Definition of “placing on the market” linked to economical ownership;
  • Economical ownership only counts for goods already produced;
  • CE Mark certificates of UK-based Notified Bodies will become void after Brexit day;
  • No exceptions made for medical devices when it comes to certificates.
The European Commission speaks

The European Commission has published new recommendations in Q&A format for obtaining CE Mark certification and placing industrial products including medical devices...

Source | Ronald Boumans
Feb 5, 2019
Canada | Digital Health Products, Medical Devices

Health Canada Establishing Regulatory Framework for Software as a Medical Device (SaMD)

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Health Canada proposing regulatory requirements for software as a medical device (SaMD).
  • Proposed Health Canada regulations for SaMD based on International Medical Device Regulators Forum (IMDRF) guidelines.
  • Health Canada SaMD regulations would exclude products such as electronic health records and wellness apps.

Canadian healthcare market regulators have drafted proposed market authorization requirements for software as a medical device (SaMD) and related technologies.

Health Canada is...

Source | Stewart Eisenhart
Feb 4, 2019
Europe | In-Vitro Diagnostic Devices, Medical Devices

Spotlight on Brexit: BSI encouraging manufacturers to apply for certification transfer

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Cliff Edge Brexit remains a likely scenario.
  • It may take weeks (or longer) before there will be certainty about a Brexit outcome.
  • BSI is urging its clients to transfer their certifications from their UK entity to their Dutch entity.
  • Manufacturers must take the initiative and transfer their certifications as soon as possible.

The United Kingdom (UK) has voted to leave the European Union (EU) – also called Brexit. Negotiators from the EU and the UK had reached an agreement, which has however...

Source | Ronald Boumans
Jan 31, 2019
Worldwide | Medical Devices

Spotlight on Human Factors Engineering: Should kids be operating medical devices independently?

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Manufacturers whose intended users include children must consider pertinent human factors and usability issues when designing their medical devices.
  • Issues pertaining to working memory capacity in children should be accommodated by companies whose devices target minors to ensure safe and effective use.

Consider a 10-year-old boy. He’s energetic, a bit mischievous, and pretty busy with school and friends.   Now let’s throw a Type 1 diabetes diagnosis into his life. Suddenly, following the emergence of medical...

Source | Stephanie Bassock
Jan 30, 2019