(by Nick Paul Taylor)
Two new guidance documents from the European Commission’s Medical Device Coordination Group (MDCG) aim to provide more information on applying new medtech regulations.
First up is the guidance to notified bodies on verifying in vitro diagnostic (IVD) devices in class D, the highest risk category. The incoming In Vitro Diagnostic Regulation (IVDR) reserves class D for tests that could pose a high risk to both patients and public health, such as products that check for transmissible agents in blood to be transfused. Given the risks, IVDR mandates a more complex conformity assessment process for class D IVDs that involves notified bodies and European Union reference laboratories (EURL).
As the guidance explains, notified bodies need to verify batches of class D IVDs. Verification will require notified bodies to work with both manufacturers and EURLs.
Manufacturers must share reports of their class D IVD tests with their notified bodies and make samples available for testing. Notified bodies are responsible for arranging for EURLs to perform batch testing of provided samples. After performing batch testing, the EURL will share its findings with the notified body. The completion of the verification step clears the manufacturer to market the device, unless the notified body flags a problem within 30 days of receiving the samples.
The guidance also provides advice on how notified bodies can meet those responsibilities. Notified bodies need documented procedures for the verification process, a test plan that covers all critical device parameters, and an agreement with the manufacturer about sample logistics.
MDGC is advising notified bodies to include a test plan, approved by the EURL, that covers information such as the samples to be tested, test frequency and the test platform to be used. The agreement also should address the logistics of how manufacturers will get samples to their notified bodies or EURLs. Manufacturers should commit to tell notified bodies if they send samples directly to EURLs and if they make changes that may affect batch verification.
The guidance also addresses the written contract between the notified body and EURL. Again, MDGC expects the notified body to include the test plan in the agreement. EURL-specific contract requirements include the inclusion of the laboratory’s fees and an estimated timeframe for testing and reporting the findings. The maximum timeframe is 30 days.
Legacy device oversight
One day after releasing the class D IVD document, MDCG published guidance on surveillance of legacy devices that are allowed to stay on the EU market until May 2024 with valid certificates issued under Active Implantable Medical Devices Directive (AIMDD) or Medical Devices Directive (MDD).
The guidance addresses a question raised by the Medical Device Regulation (MDR). Under MDR, legacy devices can stay on the EU market until 2024 if they comply with the old directives and do not undergo significant changes. However, MDR also requires legacy devices to meet the regulation’s requirements on post-market surveillance, market surveillance, vigilance and registration of economic operators. Given that, how should notified bodies handle surveillance of quality management systems for legacy devices?
MDCG’s guidance answers that question, instructing notified bodies to take account of the new requirements in the framework of their surveillance activities. In practice, that means MDCG wants notified bodies to review the quality management system documentation, checking whether the manufacturer has made adjustments in line with MDR, and then use the outcome of the assessment to determine the audit program.
As only certain MDR requirements apply to legacy devices, “the audit activities to be performed by notified bodies should be a continuation of the previous surveillance activities with a focus on the new provisions,” the guidance states. Manufacturers should make Periodic Safety Update Reports and Post Market Surveillance plans and reports available to their notified bodies so they can “verify that the quality management system has been appropriately adapted and remains compliant for the certificate(s) issued under the MDD or the AIMDD.”
The rest of the guidance describes scenarios notified bodies may encounter depending on where manufacturers are in the MDR process. MDCG’s advice on how to approach surveillance differs depending on whether, for example, the manufacturer is going to remove its device from the market by 2024 or is already certified by another notified body under MDR.
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