Worldwide medical device QA/RA blog

News and commentary on regulatory changes.

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That is why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you.

Eudamed Update: Actors module testing

EMERGO SUMMARY OF KEY POINTS:

  • The Eudamed project is following its original schedule.
  • The  first module has been tested by users.
  • The development of specific procedures by the Competent Authorities is outside the reach of the Commission, but this will just be as important as the development of Eudamed.
  • Industry needs time for developing and testing their interfaces, and this could be set up by giving them access to the draft modules.
Read more about Eudamed Update: Actors module testing...

European Regulators Publish UDI Guidance

EMERGO SUMMARY OF KEY POINTS:

  • The Basic UDI-DI is the key identifier of a device in Eudamed, on certificates and on the Declaration of Conformity.
  • Multiple UDI-DIs can be linked to a single Basic UDI-DI, while a UDI-DI must be linked to only one Basic UDI-DI.
  • The UDI-DI must unambiguously identify a device in the distribution chain; any change that may confuse identification should result in a new UDI-DI.
  • Manufacturers can now identify the data elements and formats for developing their databases in preparation of the introduction of UDI in Europe.
Read more about European Regulators Publish UDI Guidance...

Eudamed Nomenclature Requirements Published

EMERGO SUMMARY OF KEY POINTS:

  • The MDCG endorsed the requirements for nomenclature to be used in Eudamed.
  • This nomenclature will be made available for free to stakeholders and others.
  • Availability of the nomenclature in all EU languages is considered highly important, but it is not worded as a hard requirement.
  • It can be expected that the nomenclature system will be selected in 2018, although there is no confirmation by the authorities on that timeline.
Read more about Eudamed Nomenclature Requirements Published...

US FDA Proposes Expanding Abbreviated 510(k) Program for Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has proposed expanding its Abbreviated 510(k) Program for medical devices utilizing well-understood technologies.
  • Expanding the abbreviated premarket notification pathway would provide faster US market access for some devices and streamline FDA review activities.
  • FDA plans to issue additional guidance on program criteria in the coming months.
Read more about US FDA Proposes Expanding Abbreviated 510(k) Program for Medical Devices...

Canadian Regulators Launching Tailored Approach to Digital Health Technologies

EMERGO SUMMARY OF KEY POINTS:

  • Health Canada is establishing a new division for premarket review of digital health technologies.
  • The new Digital Health Review Division will handle licensing of wireless medical devices, mobile medical apps and related digital health products.
  • Health Canada plans to align its new division with similar digital health oversight initiatives by the US FDA and other regulators.
Read more about Canadian Regulators Launching Tailored Approach to Digital Health Technologies...

Mexican Regulators Overhaul Medical Device, IVD Classification Rules

EMERGO SUMMARY OF KEY POINTS:

  • Mexican regulators have updated classification and related requirements for medical device and IVD registrants.
  • COFEPRIS has up-classified most IVD products and clarified definitions pertaining to medical device regulations.
  • COFEPRIS first announced these planned changes in early 2017.
Read more about Mexican Regulators Overhaul Medical Device, IVD Classification Rules...

US FDA Preps Enhancements to Global Unique Device Identification Database (GUDID)

EMERGO SUMMARY OF KEY POINTS:

  • US FDA will release Global Unique Device Identification Database (GUDID) information including premarket submission and supplement numbers to the public in summer 2018.
  • Medical device registrants should familiarize themselves with FDA plans and review their own confidentiality designations immediately.
  • FDA will begin releasing GUDID data to the public in June 2018.
Read more about US FDA Preps Enhancements to Global Unique Device Identification Database (GUDID)...

Here Come the Exoskeletons

My colleagues and I are excited by the current value and future potential of exoskeletons in healthcare. Applications of particular interest are the accommodation and treatment of partial paralysis and other types of musculoskeletal impairments, some of which are caused by a stroke.

Read more about Here Come the Exoskeletons...

Japanese Regulators Raise Medical Device Registration Fees

EMERGO SUMMARY OF KEY POINTS:

  • The Japanese PMDA has increased marketing application review fees for nine medical device categories.
  • The new fees went into effect April 1, 2018.
  • PMDA application review fee increases range from eight to 15%.
Read more about Japanese Regulators Raise Medical Device Registration Fees...

Brexit Agreement: Reset your clocks!

EMERGO SUMMARY OF KEY POINTS:

  • European and UK negotiators strike a deal
  • Transitional period until 31 December 2020: 21 months extra
  • The MDR will apply in the UK; it is likely this will also happen for the IVDR
  • A mutual agreement would enable movement of medical devices between the UK and EU, but whether this is politically achievable remains unknown
Read more about Brexit Agreement: Reset your clocks!...

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