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.

Brexit: The Hard Reality of “No Deal” for the Medical Device Industry

EMERGO SUMMARY OF KEY POINTS:

  • All economic operators in Europe, the UK and in the rest of the world may face significant consequences of Brexit.
  • The distribution network of medical devices currently placed on the market by UK based importers must be reviewed.
  • EU distributors currently placing UK manufactured devices on the market may have a different role.
  • Unless a fitting deal has been made, all certificates issued by British Notified Bodies on EU regulations/directives will become void from 30 March 2019.
  • Notified Bodies are already anticipating this scenario.
Read more about Brexit: The Hard Reality of “No Deal” for the Medical Device Industry...

Europe: Development of Eudamed Well on Schedule

EMERGO SUMMARY OF KEY POINTS:

  • Eudamed functional specifications expected to be released in May of this year
  • Eudamed expected to go live in March 2020
  • As with all plans: there are some uncertainties regarding the execution of this plan
Read more about Europe: Development of Eudamed Well on Schedule...

Brazil’s ANVISA Streamlines Medical Device Importation Processes

EMERGO SUMMARY OF KEY POINTS:

  • A new ANVISA resolution has simplified medical device importation requirements for Brazil.
  • Imported devices no longer have to undergo inspections at Brazilian points of entry.
  • Additional changes to simplify ANVISA importation requirements are anticipated in the near future.
Read more about Brazil’s ANVISA Streamlines Medical Device Importation Processes...

US FDA Delays Contentious Medical Device Intended Use Rule

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has indefinitely delayed new requirements for evidence used to determine intended use.
  • The intended use-related requirements are part of a larger final rule covering tobacco products that fall under US medical device regulations.
  • The other parts of the final rule will go into effect in March 2018.
Read more about US FDA Delays Contentious Medical Device Intended Use Rule...

FDA Formalizes UDI Compliance Deadline Extension for Low-risk Devices

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has published guidance setting new UDI compliance deadlines for some Class I and unclassified medical devices.
  • The new deadlines were initially proposed in summer 2017.
Read more about FDA Formalizes UDI Compliance Deadline Extension for Low-risk Devices...

UK Takes Stricter Stance on Human Factors Engineering for Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • Human Factors Engineering (HFE) guidance from the UK MHRA differs in some areas from recommendations issued by the European Union.
  • The MHRA focuses its recommendations on HFE and usability engineering during medical device development.
  • In some areas, the MHRA guidance hews closer to US FDA recommendations than European standards.
Read more about UK Takes Stricter Stance on Human Factors Engineering for Medical Devices ...

Latest Chinese Medical Device Regulatory Changes Affect Clinical Trials, Testing, Telehealth

EMERGO SUMMARY OF KEY POINTS:

  • Chinese medical device market regulators at the CFDA have published new and updated regulations covering clinical trial requirements, mobile medical technologies and device testing issues.
  • The updates include technical guidance on clinical trial designs and mobile medical devices, as well as a notice on funding for local-level device testing centers.
Read more about Latest Chinese Medical Device Regulatory Changes Affect Clinical Trials, Testing, Telehealth...

New European Borderline and Classification Manual Published

EMERGO KEY POINTS:

  • An updated version of the European Borderline and Classification Manual for medical devices and IVDs is now published.
  • The latest manual will be of limited use once the European Medical Devices Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) go into effect because of different definitions and classification rules.
Read more about New European Borderline and Classification Manual Published...

Australian TGA Adopts Priority Review Approach for Medical Devices and IVDs

EMERGO KEY POINTS:

  • New Australian TGA guidance establishes a priority review designation pathway for cutting-edge and novel medical devices and IVDs.
  • Qualifying devices must meet criteria pertaining to serious diseases or conditions, unmet clinical needs and breakthrough technologies.
  • TGA decisions on priority review designation applications will take no more than 20 business days.
Read more about Australian TGA Adopts Priority Review Approach for Medical Devices and IVDs...

Can Medical Robots Make Mistakes?

What is the likelihood of medical robots making mistakes on their own rather than because of human error?

Read more about Can Medical Robots Make Mistakes?...

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