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Global Medical Device News

Worldwide | Medical Devices

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


  • 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


  • 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


  • 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


  • 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


  • 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
Europe | In-Vitro Diagnostic Devices, Medical Devices

European Commission’s Latest Updates to Borderline & Classification Manual


  • Second update IN 2018 of the Manual on Borderline and Classification.
  • Five new cases added, providing useful illustrations of how the definition of a medical device and the classification rules should be understood.
  • For the MDR there could be some significant differences.

On October 30, 2018 the European Commission published the most recent version of the Borderline & Classification Manual. This document provides guidance on establishing the status of medical devices and IVDs, as well as their risk...

Source | Ronald Boumans
Nov 12, 2018
China | Medical Devices

Chinese Regulators Revamp Innovative Medical Device Review Process


  • The Chinese National Medical Products Administration (NMPA) has published revised requirements for its innovative medical device review program.
  • NMPA updates to the innovative device registration program take effect December 1, 2018.

The National Medical Products Administration (NMPA), China’s medical device market regulator, has developed new procedures taking effect December 1, 2018 for premarket reviews of innovative devices.

The new NMPA policy,...

Source | Stewart Eisenhart
Nov 8, 2018
United States | Medical Devices

US FDA Updates UDI Policy for Direct Marking of Medical Devices


  • US FDA has revised UDI direct marking requirements and deadlines for some non-sterile, Class I and unclassified medical devices.
  • UDI policy changes were prompted to assist manufacturers manage compliance for devices in inventory and avoid potential device shortages.

The US Food and Drug Administration has revised its Unique Device Identification (UDI) regulation’s direct mark requirements and compliance deadlines in response to cost and inventory concerns raised by industry.

In new, immediately effective...

Source | Stewart Eisenhart
Nov 8, 2018
Europe | In-Vitro Diagnostic Devices, Medical Devices

MDR and IVDR Implementation: Update from the European Commission


  • MDR and IVDR implementations still on track as planned.
  • The first Notified Bodies to be designated may be announced by the end of 2018.
  • Eudamed is advancing as planned.
  • Brexit is a matter of concern, but all UK based Notified Bodies appear to be taking appropriate actions.

The European Commission reports that implementation efforts for the EU Medical Devices Regulation (MDR) 2017/45 and In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 remain on track, as well as related efforts...

Source | Ronald Boumans
Nov 5, 2018