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.

In Brief: Full Enforcement of Malaysian Medical Device Regulations Set for July 1, 2018

EMERGO SUMMARY OF KEY POINTS:

  • Malaysian medical device registration rules will come into full force in July 2018.
  • Companies currently using Acknowledgment Letters to sell their devices in Malaysia will need to obtain full registration by June 30, 2018.
Read more about In Brief: Full Enforcement of Malaysian Medical Device Regulations Set for July 1, 2018...

US FDA: No Additional Regulations for Medical Device OEMs and Third-party Service Providers

EMERGO SUMMARY OF KEY POINTS:

  • US FDA issues a required report on the continued quality, safety, and effectiveness of medical device servicing.
  • Evidence is insufficient to determine whether additional regulations are necessary for OEMs and third-party service companies.
  • The FDA proposes additional actions based on the report’s findings.
Read more about US FDA: No Additional Regulations for Medical Device OEMs and Third-party Service Providers...

Spring 2018 Updates to European Medical Device Borderline and Classification Manual

EMERGO SUMMARY OF KEY POINTS:

  • A new version of the Manual on Borderline and Classification has been published.
  • The seven new positions do not contain surprises.
  • It appears the MDEG is not yet involved in device status or classification questions regarding the MDR or IVDR.

On April 23 2018 the European Commission published Version 1.19 of the Manual on Borderline & Classification. Following the release of Version 1.18 in December 2017 it appears the Medical Devices Expert Group (MDEG) on Borderline & Classification is quite active.

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Medical Device QMS Harmonization: US Considers Aligning to ISO 13485

EMERGO SUMMARY OF KEY POINTS:

  • US FDA is considering adoption of ISO 13485:2016 quality system requirements for medical device registrants.
  • ISO 13485 would replace FDA Quality System Regulations (QSR) according to proposed rules.
  • FDA alignment to ISO 13485 quality principles would align the US market pathway more closely to other major device markets.
Read more about Medical Device QMS Harmonization: US Considers Aligning to ISO 13485...

ANVISA Changing Brazilian Market Pathway for Low-risk Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • Brazil’s ANVISA plans to replace the cadastro registration route for Class I medical devices with a notification pathway based on IMDRF recommendations.
  • Stakeholders will have 60 days to submit comments on the proposed change once ANVISA publishes its official public consultation.
Read more about ANVISA Changing Brazilian Market Pathway for Low-risk Medical Devices...

Saudi Regulators Extend Deadline for Low-risk Medical Device Registrations

EMERGO SUMMARY OF KEY POINTS:

  • Saudi regulators have delayed enforcement of a new expedited market pathway for Class I non-sterile, non-measuring medical devices.
  • Starting in September 2018, qualifying devices may apply for listing in the Saudi Medical Device National Registry (MDNR) without undergoing full SFDA review.
Read more about Saudi Regulators Extend Deadline for Low-risk Medical Device Registrations...

European Medical Device Regulatory Roundup: May 2018

Major changes underway in the European medical device and IVD markets require manufacturers to keep up with many complex moving parts. Issues including implementation of the MDR and IVDR, ramifications of Brexit and tightening Notified Body requirements have resulted in a more challenging CE Mark certification process for many companies.

Read more about European Medical Device Regulatory Roundup: May 2018...

US FDA Clarifies Policy on Multiple-Function Medical Device Oversight

EMERGO SUMMARY OF KEY POINTS:

  • New guidance explains FDA approach to multiple-function products that feature device and non-device components.
  • FDA may assess non-device components of a multi-function product to determine their impact on the safety and effectiveness of the product’s features that do meet the definition of a medical device.
Read more about US FDA Clarifies Policy on Multiple-Function Medical Device Oversight...

US Regulators Propose Expanded Medical Device Cybersecurity Approach

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has proposed various measures to boost cybersecurity risk mitigation in a new Medical Device Safety Action Plan.
  • The agency has also proposed merging pre- and post-market units of its Center for Devices and Radiological Health (CDRH) division.
  • A proposed new Cybermed Safety (Expert) Analysis Board would coordinate cybersecurity risk management efforts between industry and FDA, according to the new plan.
Read more about US Regulators Propose Expanded Medical Device Cybersecurity Approach...

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...

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