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Regulatory Affairs Updates 36/20

Medical Devices - Guidelines and Regulations Worldwide


Europe

EUDAMED

The MDCG released the position paper MDCG 2020-15 on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) where they confirm its readiness to deploy the module as of 1 December 2020. The actor registration module provides a unique SRN to the competent authority for every manufacturer, authorized representative or importer who registers on EUDAMED. The authority approves the SRN which then e.g. can be stated on certificates. As one of six modules the actor registration module forms a precondition for the use of the other EUDAMED modules and facilitates a secure way of accessing EUDAMED.


First final Common Specification

The MDR allows reprocessing of single-use devices only where it is permitted by national law. It also allows Member States not to apply all of the rules regarding manufacturers’ obligations laid down in the MDR. One of the conditions for such reprocessing is that it is performed in accordance with common specifications.

The new regulation (EU) 2020/1207 finally lays down those rules for common specifications for the reprocessing of single-use devices. Concerning risk management they should include minimum requirements for staff, premises and equipment to ensure the quality of the reprocessing activities. Those minimum requirements are set up in the new regulation, e.g. the preliminary assessment of the suitability of a single-use device for reprocessing which has to be done by the health institution.

The Regulation also lays down rules regards single-use devices that are reprocessed by an external reprocessor.


COVID-19

Canada

Health Canada published regulatory considerations for importing or selling face shields which are considered medical devices in Canada and therefore must follow the requirements outlined in the Medical Devices Regulations. A face shield has a transparent window or visor that shields the face and associated mucous membranes and thereby can help prevent potential exposure to infectious disease. The article states standards and requirements for face shields and gives an overview about regulatory authorization pathways.


Australia

On their website, the TGA provides information and FAQ on disinfectants. They are addressed to new sponsors seeking to supply disinfectants for the first time during the COVID-19 pandemic. But they also contain regulatory requirements for disinfectants and other information that can be useful for manufacturers.


USA

The FDA released two final guidances that identify performance criteria and testing methodologies for specific medical device types (Cutaneous Electrodes for Recording Purposes and Conventional Foley Catheters). Those performance criteria allow manufacturers of the respective devices to take the Safety and Performance Based Pathway which is an expansion of the concept of the Abbreviated 510(k) pathway for certain, well understood device types. The manufacturer proves that a new device meets FDA-identified performance criteria to demonstrate that the new device is as safe and effective as a legally marketed device. The FDA wants to continue to issue guidances to apply this Safety and Performance Based Pathway to additional types of devices that can be suggested by the industry. More information on how to prepare and submit a 510(k) using the Safety and Performance Based Pathway under this link:


Japan

The Japanese Ministry of Health, Labour and Welfare (MHLW) publishes two worth reading articles about medical devices which are part of their monthly Pharmaceuticals and Medical Devices Safety Information.

First one is about Recent Trends in Cybersecurity Assurance of Medical Devices. The increasing ability of medical devices to be connected to medical institutions' networks and to exchange data with external devices during their use also means increased opportunities for them to be exposed to the risk of unauthorized access from outside via data communication. The article introduces the Japanese and international efforts in dealing with cybersecurity of medical devices including the status of related risk analysis in Japan with some examples in other countries.


The second one is about Initiatives to Ensure Safety of Homecare Medical Devices against Radio Waves Emitted by Mobile Phones, etc. containing e.g. the following topics:

  • International trends concerning requirements for electromagnetic immunity of medical devices (IEC 60601-1-2)
  • Investigation and verification by the Ministry of Internal Affairs and Communications on the impact of radio waves emitted by mobile phones on medical devices
  • Information leaflets to the users, their families or other caregivers

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All updates compiled in one PDF file:

You can download all Regulatory Affairs Updates compiled for you as a PDF under the following link.

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