Second Corrigendum by EU MDR grants grace period for some self-certified Class I medical devices

The European Parliament adopted the second corrigendum of the Medical Devices Regulation (EU) 2017/745 (MDR) pg 44 of 145 for English, with significant compliance deadline implications for some currently self-certified devices.

This change suggests that devices (not custom made devices) that are self-certified Class I under the current Medical Devices Directive 93/42/EEC (MDD) but that will be up-classified under the MDR will not have to be certified to the new Regulation from the Date of Application (May 26th, 2020). Instead, qualifying devices may rely on the Declaration of Conformity drawn up under the MDD until May 25th 2024. This will impact many self-certified devices:

  • Class I reusable surgical devices;
  • Software, most of which would be up-classified to Class IIa or higher;
  • Many self-certified substance-based devices, of which some would be up-classified as far as Class III;
  • And many others.

Although most MDR requirements will apply, this delay in certification is not a delay in application of the MDR.

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US FDA issues detailed Framework for the Safety and Performance Based Pathway for abbreviated 510(k) medical device review

As a first step towards operationalizing of the Safety and Performance Based Pathway, the FDA has issued draft guidances identifying performance criteria and testing methodologies for certain devices within five class II device types. The FDA expects to operationalize this pathway once the first device types and applicable performance criteria have been identified and final guidances have been published. Once the FDA begins to operationalize this pathway, a medical device manufacturer will have the option to meet FDA-identified performance criteria to demonstrate that its device is as safe and effective as a predicate device. The use of this pathway does not affect the FDA’s ability to request any information authorized by the statute or regulations.

This framework identifies five Class II device types for which the agency intends to establish performance criteria and testing methodology guidances ahead of launching the Safety and Performance Based Pathway:

  1. Spinal plating systems
  2. Cutaneous electrodes for recording purposes
  3. Conventional Foley catheters
  4. Orthopedic non-spinal metallic bone screws and washers
  5. Magnetic resonance coils

The Safety and Performance Based Pathway is appropriate when FDA has determined that:

  • The new device has the same indications for use as, and technological characteristics that do not raise different questions of safety and effectiveness than the identified predicate; and
  • The new device meets all the FDA-identified performance criteria.

If any of the above factors are not met, the submitter has the option to submit a Traditional, Special or Abbreviated 510(k).

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ANVISA: Reached milestone of 5000 international health product certifications using MDSAP in 2019

Brazilian medical device market regulator, ANVISA, according to a recent report showed a significant increase in medical device manufacturers participating in the Medical Device Single Audit Program (MDSAP), with nearly half of all quality management system certifications issued in 2019 under MDSAP.

According to the report, the Medical Device Single Audit Program (MDSAP) reached, in 2019, the milestone of 5,000 participating companies. In addition, 48.7% of the total international health product certifications issued by ANVISA this year were made using the program. The number of device manufacturing sites in Brazil that participate in was 3,225 in 2017 and 778 in 2017.

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South Korean Ministry of Food and Drug Safety: Submission requirements for high-risk medical devices reduced

South Korean MFDS have reduced the registration submission requirements for Class-IV medical devices. This notice is expected to reduce submission preparation timeframes for Class IV device applicants, and potentially eases South Korean market entry.

As per the notice from MFDS, manufacturers of Class IV devices will no longer be required to prepare and submit full Summary Technical Documentation (STED) files along with Korean technical files when applying for South Korean market authorization. Instead, following STED-related documentation from Class IV device market applicants would be required:

  • Flow charts showing each step of the device’s manufacturing process;
  • Detailed explanations of processes that could affect the performance and/or effectiveness of the device;
  • Descriptions and indications of all sterilization methods, standards, validation cycles and conditions utilized in the device’s manufacturing process.
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Singapore Health Sciences Authority: new guidance on special authorization routes for unregistered medical devices

The Singapore Health Sciences Authority (HSA) has issued new guidance on Special Authorization Routes (SARs) for the unregistered medical devices in the country.

These SARs allow qualified healthcare providers in Singapore to utilize unregistered devices in case of emergencies, or when more conventional therapies have proven unsuccessful. The new guidance covers application processes, requirements and post-market obligations that must be met in order to import an unregistered device into Singapore via SAR. Devices that meet “special clinical needs,” intended for import/export, as well as those with non-clinical intended uses or purposes may be fall under HSA’s SAR program to obtain Singapore market entry.

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CDSCO India: Regulatory updates on Medical device and IVDs announced

Central Drugs Standard Control Organization (CDSCO), India has rolled out several changes to its regulatory process for medical devices and in-vitro diagnostic medical devices.

List of regulated medical devices- CDSCO has added ultrasound equipment to its list of medical devices falling under regulatory requirements in India. Compliance deadline of November 1, 2020 has been set for registration of ultrasound products to market in Indian.

Devices requiring Performance Evaluation Reports: CDSCO has identified several IVD products including tests for HIV, HBV, HCV and blood grouping reagents for which Performance Evaluation Reports (PER) will be required from external labs to be included in Import Permit Applications.

Exemption for state and central government testing laboratories: CDSCO has issued a notification exempting all state and central government testing laboratories from National Accreditation Board for Testing and Calibration Laboratories (NABL) requirements for two years; these labs now face an October 2021 deadline for meeting NABL requirements.

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MHRA explains role of UK responsible person

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have published new details on the role and responsibilities of the UK Representative if a no-deal Brexit withdrawal from the European Union comes to pass.

The updated guidance document explained the rules of how non-UK manufacturers could place their devices on the UK market. The manufacturers would have to engage with a ‘UK REP’ or ‘UK. Responsible Person’. The role of the UK REP was described as quite similar to that of the Authorized Representative

It is only allowed for UK based manufacturers or UK-based UK REPs to place medical devices on the UK market, and they need to register themselves. The manufacturer and UK REP will also be held liable for defective devices and they can be proceeded against under the Regulations or under the Consumer Protection Act 1987.

The UK REP is also responsible for carrying out post-market surveillance activities.

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US FDA: guidance for abbreviated 510(k) programs finalized, updates Refuse to Accept policy

The US FDA’s Center for Devices and Radiological Health (CDRH) has issued final guidance for its Abbreviated 510(k) premarket notification pathways following proposals in 2018 to expand access to these programs, as well as its Refuse to Accept policy for inadequate or incomplete 510(k) submissions.

Abbreviated 510(k) program

FDA and CDRH have finalized the guidance on the Abbreviated 510(k) program, wherein manufacturers may utilize existing relevant FDA guidance documents, standards and special controls to qualify for expedited premarket notification review.

The final guidance identifies the content to be included in an Abbreviated 510(k) application, including device indications for use and labeling data, summary reports of how any relevant guidance, special controls or standards support substantial equivalence claims, and any supplementary information to address issues not covered by guidance, controls or standards.

Refuse to Accept policy

US FDA has finalized guidance updates from early 2019 to the Refuse to Accept policy that establishes minimum acceptability thresholds for medical device 510(k) submissions. FDA’s Refuse to Accept (RTA) guidance includes acceptance checklists for traditional as well as Abbreviated and Special 510(k) application routes.

US medical device market applicants should stay up to date on FDA’s RTA policy in order to avoid potentially costly registration delays.

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USFDA updates on hike in user fees for the 2020 fiscal year

US Food and Drug Administration medical device have increased the user fees by about six percent for 510(k) premarket notifications, Premarket Approvals (PMAs) and other market registration applications for the 2020 fiscal year.

FDA’s user fee schedule for 2020 shall take effect from October 1, 2019, and entails six-percent increases for both standard and small-business rates. The agency’s 2020 fiscal year increases are slightly higher compared to four-percent increases for 2019 for most user fees.

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TGA have implemented the cybersecurity regulatory recommendations

Australia’s Therapeutic Goods Administration (TGA) has implemented the final guidance on pre- and post-market cybersecurity regulatory recommendations for medical device, software and IVD manufacturers and sponsors.

The TGA guidance applies to software as a medical device (SaMD) as well as medical devices and IVDs incorporating components that may be vulnerable to cyber threats.

The TGA guidance aligns closely with regulatory approaches developed by the USFDA and Health Canada, based on total product lifecycle (TPLC) principles for risk and quality management. Convergence of TGA cybersecurity requirements with US FDA draft pre-market guidance and final post-market guidance on cybersecurity risk management, Health Canada cybersecurity guidance finalized in June 2019, and South Korean MFDS cybersecurity guidelines shows an increasingly harmonized regulatory response to emerging cybersecurity risks and threats to connected healthcare environments.

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