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Global Medical Device News

Hong Kong | In-Vitro Diagnostic Devices, Medical Devices

Hong Kong Medical Device Regulatory Update: IVD listings, acceptance period for NMPA approvals

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Hong Kong MDCO to allow listing of IVD devices in Medical Device Administrative Control System (MCAS) starting in February 2019.
  • MDCO’s trial program allowing easier market entry for some devices approved in China extended to late 2019.

Hong Kong’s medical device regulator, the Medical Device Control Office (MDCO), has updated listing requirements for moderate- and high-risk IVD devices as well as extended a trial program whereby certain medical devices approved for sale in China are accepted as having met...

Source | Stewart Eisenhart
Jan 30, 2019
United States | Medical Devices

US FDA Pushes 510(k) Performance Criteria, Predicate Device Policy Changes

EMERGO BY UL SUMMARY OF KEY POINTS:

  • US FDA finalizes Safety and Performance 510(k) registration route;
  • Performance criteria to play greater role in substantial equivalence for qualifying devices;
  • 510(k) predicate device policies still slated for revision.

The US Food and Drug Administration’s medical device oversight division has rolled out final guidance on an expanded 510(k) registration route retooled to focus on device safety and performance issues, and is seeking industry comment on proposed changes to its predicate device policy...

Source | Stewart Eisenhart
Jan 25, 2019
Worldwide | Medical Devices, Retail

Human Factors Engineering and Usability: What you should know about diary studies

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Use of diary studies as tools for human factors research and design applications increasing
  • Diary studies providing more efficient access to longitudinal data

“Dear diary, Today I…”

Some people might assume that diaries are only used to record the day-to-day trials and musings of teenagers. But – surprise! – diaries (specifically, diary studies) are actually a valuable method to add to your ethnographic research toolkit. Generally speaking, a diary study is a qualitative research method that...

Source | Erin Davis and Benjamin Basseches
Jan 23, 2019
Europe | In-Vitro Diagnostic Devices, Medical Devices

BSI Becomes First Notified Body Designated under Europe's MDR

EMERGO BY UL SUMMARY OF KEY POINTS:

  • The designation of BSI UK is in NANDO;
  • This does not cover BSI NL;
  • Other Notified Bodies are expected to follow soon.

The new Medical Devices Regulation (EU) 2017/745 is not an update of the current Medical Devices Directive 93/42/EEC (MDD) and the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD); it requires all devices to be certified again.

Except for Class I, self-certified devices, all devices require new certification by a Notified Body (NB). NBs can only certify...

Source | Ronald Boumans
Jan 22, 2019
United Kingdom | Medical Devices

Latest Brexit Agreement Voted Down by British Parliament

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Proposed agreement for leaving the EU voted down in UK Parliament
  • UK government survives vote of no confidence
  • New plan to be presented in Parliament on January 21, 2019
  • No-deal Brexit has again become a more realistic option
  • The EU will only allow for a delay if there are new facts justifying more time

On January 15th, 2019, the UK Parliament voted the Brexit agreement down by a record majority of 432 against 202. The Brexit agreement was the result of negotiations between the EU...

Source | Ronald Boumans
Jan 17, 2019
United States | Digital Health Products, Medical Devices

US FDA’s Pre-Cert Pilot for Medical Device Software Moving into Testing Phase

EMERGO BY UL SUMMARY OF KEY POINTS:

  • US FDA has issued a new regulatory framework, working model and test plan for its Pre-Cert pilot program for Software as a Medical Device (SaMD).
  • The FDA Pre-Cert regulatory pathway would utilize FDA’s De Novo classification request framework for qualifying SaMD products.
  • FDA is accepting comments on these Pre-Cert updates through March 8, 2019.

The US Food and Drug Administration has issued major updates to its Software Precertification Program (Pre-Cert) pilot program for software and digital...

Source | Stewart Eisenhart
Jan 16, 2019
China | Medical Devices

China’s NMPA Launches Voluntary Device Master File Process

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Chinese regulators are launching a record filing process for medical device master files (DMFs).
  • DMFs are used by NMPA reviewers and Chinese market applicants during device registrations.
  • The new process will be voluntary.

The Chinese National Medical Products Administration (NMPA) plans to establish a formal record filing process for Device Master Files for use in medical device registrations.

NMPA has published draft...

Source | Stewart Eisenhart
Jan 9, 2019
Europe | Medical Devices

Spotlight on PMCF: Requirements Ramping Up under European Medical Devices Regulation

EMERGO BY UL SUMMARY OF KEY POINTS:

  • The European Medical Devices Regulation (MDR) will tie post-market clinical follow-up (PMCF) data more closely to post-market surveillance and clinical evaluation report requirements.
  • Medical device companies’ PMCF studies will have to include specific components identified in the MDR.
  • Approvals for PMCF studies will need to be obtained by Ethics Committees and, in some cases, Competent Authorities.

Requirements for manufacturers to provide clinical data obtained via post-market clinical follow-up (...

Source | Aleksandra Klimaszewski and Stewart Eisenhart
Jan 8, 2019
United Kingdom |

MHRA Guidance on a No-Deal Brexit

EMERGO BY UL SUMMARY OF KEY POINTS:

  • MHRA will take on responsibility for the UK market;
  • The CE Mark remains valid in the UK and no label changes are foreseen for now;
  • MDR and IVDR will be implemented in the UK in parallel with the EU
  • Non-UK manufacturers placing devices on the UK market need to appoint a UK Responsible Person, a role similar to that of the European Authorized Representative
  • The UK-based manufacturer or the UK Responsible Person must register the device in the UK.

On January 3rd, 2019, the...

Source | Ronald Boumans
Jan 7, 2019
United States | In-Vitro Diagnostic Devices, Medical Devices

US Government Shutdown Halts New FDA Medical Device Registration Activities

EMERGO BY UL SUMMARY OF KEY POINTS:

  • A partial US government shutdown has resulted in the suspension of FDA’s authority to collect medical device application user fees for the 2019 fiscal year.
  • Inability to collect user fees means FDA cannot accept any new medical device registration applications that require such fees until full US government funding resumes.
  • FDA will continue to carry out oversight functions related primarily to high-risk medical devices, imported product screenings and novel therapies.

A partial US government...

Source | Stewart Eisenhart
Jan 3, 2019