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Global Medical Device News

Worldwide | Medical Devices

The Role of Good Clinical Practices (GCP) in Medical Device Clinical Investigations

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Good Clinical Practice (GCP) must be adhered to by medical device companies conducting clinical investigations for their products.
  • GCP requirements make exceptions for software as a medical device (SaMD) for which some developers may qualify.
  • Besides GCP, additional standards such as ISO 14155 may apply to clinical studies for medical devices.

Medical device manufacturers should ensure compliance to Good Clinical Practice (GCP) as they undertake clinical investigations to meet regulatory requirements...

Source | Aleksandra Klimaszewski and Stewart Eisenhart
Feb 14, 2019
Electronic Instructions for Use (eIFUs)
India | Medical Devices

Potential Advantages and Disadvantages of Electronic Instructions for Use (eIFUs) for Medical Devices

EMERGO BY UL SUMMARY OF KEY POINTS:

  • India has become the latest medical device market whereby regulators have begun accepting electronic indications for use (eIFU) for registrations.
  • Manufacturers can realize advantages of utilizing eIFU, but should consider how eIFU may impact other design, labeling and user interface issues.
  • Markets including the US and European Union already recognize eIFU for medical device premarket submissions.

Recently, the Indian Ministry of Health & Family Welfare granted that instructions for use (IFU)...

Source | Michael Wiklund
Feb 6, 2019
Europe | In-Vitro Diagnostic Devices, Medical Devices, Procurement/Supply Chain

European Commission Requirements for Marketing Medical Devices in a No-deal Brexit Scenario

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Definition of “placing on the market” linked to economical ownership;
  • Economical ownership only counts for goods already produced;
  • CE Mark certificates of UK-based Notified Bodies will become void after Brexit day;
  • No exceptions made for medical devices when it comes to certificates.
The European Commission speaks

The European Commission has published new recommendations in Q&A format for obtaining CE Mark certification and placing industrial products including medical devices...

Source | Ronald Boumans
Feb 5, 2019
Canada | Digital Health Products, Medical Devices

Health Canada Establishing Regulatory Framework for Software as a Medical Device (SaMD)

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Health Canada proposing regulatory requirements for software as a medical device (SaMD).
  • Proposed Health Canada regulations for SaMD based on International Medical Device Regulators Forum (IMDRF) guidelines.
  • Health Canada SaMD regulations would exclude products such as electronic health records and wellness apps.

Canadian healthcare market regulators have drafted proposed market authorization requirements for software as a medical device (SaMD) and related technologies.

Health Canada is...

Source | Stewart Eisenhart
Feb 4, 2019
Europe | In-Vitro Diagnostic Devices, Medical Devices

Spotlight on Brexit: BSI encouraging manufacturers to apply for certification transfer

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Cliff Edge Brexit remains a likely scenario.
  • It may take weeks (or longer) before there will be certainty about a Brexit outcome.
  • BSI is urging its clients to transfer their certifications from their UK entity to their Dutch entity.
  • Manufacturers must take the initiative and transfer their certifications as soon as possible.

The United Kingdom (UK) has voted to leave the European Union (EU) – also called Brexit. Negotiators from the EU and the UK had reached an agreement, which has however...

Source | Ronald Boumans
Jan 31, 2019
Worldwide | Medical Devices

Spotlight on Human Factors Engineering: Should kids be operating medical devices independently?

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Manufacturers whose intended users include children must consider pertinent human factors and usability issues when designing their medical devices.
  • Issues pertaining to working memory capacity in children should be accommodated by companies whose devices target minors to ensure safe and effective use.

Consider a 10-year-old boy. He’s energetic, a bit mischievous, and pretty busy with school and friends.   Now let’s throw a Type 1 diabetes diagnosis into his life. Suddenly, following the emergence of medical...

Source | Stephanie Bassock
Jan 30, 2019
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