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Global Medical Device News

Canada | Medical Devices

Canada’s MDSAP Transition Deadline Fast Approaching

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Health Canada’s December 31, 2018 deadline for MDSAP transition imminent.
  • Medical Device License (MDL) holders for Class II, III and IV devices must submit evidence of transition from CMDCAS to MDSAP by the December 31st deadline.

Health Canada has issued a final email reminder to medical device companies regarding the regulator’s December 31, 2018 deadline for transitioning to the Medical Device Single Audit Program (MDSAP) for quality management system compliance.

According to the Health...

Source | Stewart Eisenhart
Dec 7, 2018
United States | Medical Devices

US FDA Wants More Formalized Processes for De Novo Medical Device Classification Requests

EMERGO BY UL SUMMARY OF KEY POINTS:

  • US FDA has proposed formal policies and criteria for De Novo novel medical device classification requests.
  • The De Novo classification route allows some low- and moderate-risk devices for which substantial equivalence cannot be established to obtain US market access.
  • The proposed rules would set a 120-day review period for De Novo classification requests.

Medical device regulators at the US Food and Drug Administration have proposed a more formalized and clarifying approach to registration...

Source | Stewart Eisenhart
Dec 5, 2018
Worldwide | Medical Devices

No Shortcuts: Building Out the Right Processes to Ensure Medical Device Safety and Security

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Regulatory focus on medical device safety and risk management intensifying;
  • Functions such as clinical research, post-market surveillance and ISO 14971 compliance should bolster safety and risk management efforts;
  • More robust safety and risk management processes to help medical device companies pivot faster when regulators change requirements.

Ensuring safe and effective use of medical devices for patients and users is a crucial responsibility for manufacturers and developers, not only in terms of...

Source | Stewart Eisenhart
Dec 4, 2018
Hong Kong | In-Vitro Diagnostic Devices

In Brief: Hong Kong Regulators Launch Online IVD Classification Tool

EMERGO SUMMARY OF KEY POINTS:

  • Hong Kong regulators unveil online classification platform for IVD devices.
  • The MDCO IVD platform is designed similarly to an existing tool for medical devices.
  • MDCO medical device and IVD online classification tools are for reference purposes only.

The Medical Device Control Office (MDCO), Hong Kong’s medical device and IVD market regulator, has rolled out a new online platform to help IVD manufacturers classify their products according to the jurisdiction’s requirements.

The new MDCO...

Source | Stewart Eisenhart
Dec 3, 2018
Worldwide | Medical Devices

ISO 14155 Third Edition Preview: Role of Risk Management in Clinical Investigations

EMERGO SUMMARY OF KEY POINTS:

  • The anticipated update to ISO 14155 in 2019 includes stronger requirements for clinical risk management.
  • The third edition of the ISO 14155 medical device clinical investigation standard will align more closely to ISO 14971 medical device risk management concepts.
  • Quality management principles applied to clinical investigation audits are also introduced in ISO 14155’s latest edition.

A stronger emphasis on risk management in the ISO 14155 medical device clinical investigation standard’s latest edition has...

Source | Stewart Eisenhart
Nov 28, 2018
Worldwide | In-Vitro Diagnostic Devices, Medical Devices

Emergo by UL Regulatory Recap: Global Trends November 2018

This is our second installment of global medical device regulatory updates and observations related to global trends. In the past few months (July through November 2018), we have observed data to support several global trends. We could wax philosophical on what constitutes a trend, though suffice it to say, our professional judgement has identified the following themes:

  • Initiatives that enhance device tracking and traceability,
  • The increasing activity of the Medical Device Single Audit Program or MDSAP (in spite of Health Canada’s newly announced flexibility), and
  • ...
Source | Evangeline Loh
Nov 28, 2018
Europe | Medical Devices

European MDR Transition: Update at the Halfway Point

EMERGO SUMMARY OF KEY POINTS:

  • We are now halfway through the transition to the European Medical Devices Directive (MDR).
  • Questions regarding issues such as Notified Body designations, Eudamed specifications and Common Specifications remain open.
  • Compliance preparations by medical device manufacturers should be well underway by now.

November 26,2018 marks the halfway point in the transitional period for medical device industry to move from the current Medical Devices Directive (MDD) to the new Medical Devices Regulation (EU) 2017/745 (MDR), with a...

Source | Ronald Boumans
Nov 26, 2018
United Kingdom | In-Vitro Diagnostic Devices, Medical Devices

Draft Brexit Agreement’s Implications for Medical Device Sector

EMERGO SUMMARY OF KEY POINTS:

  • A draft agreement on Brexit has been struck between EU and UK negotiators.
  • Notified Bodies will remain recognized during the transition period.
  • It is not certain this agreement will be accepted; a cliff-edge Brexit remains a possibility.

British and European negotiators have reached a draft agreement concerning the withdrawal of the United Kingdom from the European Union (EU).

Effects for validity of CE Mark certifications and Notified Bodies

The 585-page...

Source | Ronald Boumans
Nov 16, 2018
Malaysia | Medical Devices

In Brief: Malaysian Regulators Launch New Medical Device Databases

EMERGO SUMMARY OF KEY POINTS:

  • The Malaysian MDA has launched two databases to provide information on medical device registrations and licensed establishments
  • MDA’s database for device registrations is publicly accessible, while its database for licensed establishments is intended only for Malaysia Authorized Representatives, distributors and importers.

The Malaysian Medical Device Authority (MDA) has rolled out two new databases for medical device registration information.

The first database, the...

Source | Stewart Eisenhart
Nov 14, 2018
Australia | Medical Devices

Australian TGA Regulatory Changes for Implantable Medical Devices Starting in December 2018

EMERGO SUMMARY OF KEY POINTS:

  • Australian regulators will begin requiring some implantable medical device manufacturers to provide additional product information to patients starting in December 2018.
  • The Therapeutic Goods Administration (TGA) will also require up-classification of surgical mesh devices to Class III starting in December.
  • These changes will align TGA device registration requirements more closely to the European Medical Devices Regulation (MDR).

The Australian government is set to begin requiring new market registrants of...

Source | Stewart Eisenhart
Nov 13, 2018