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Regulatory Affairs Updates 45/20

Medical Devices - Guidelines and Regulations Worldwide


Europe

The European Commission launched a new web page with basic information on the EUDAMED Actor registration module. It provides documents and information about:

  • Single Registration Number – SRN
  • Actor registration request process
  • Documents to provide with the actor registration request
  • And other useful information

The MDCG provided a list of ongoing guidance development within MDCG Subgroups.


COVID-19

Health Canada published regulatory considerations on the classification of respirators. A respirator is a piece of personal protective equipment (PPE) that forms a tight seal against the skin of the wearer. The provided information explain the circumstances under which certain respirators would be subject to the regulatory framework for medical devices during the COVID-19 pandemic.


IMDRF Update

The working group on Medical Device Clinical Evaluation (MDCE) from the International Medical Device Regulators Forum (IMDRF) proposed an update to the document on Post-Market Clinical Follow-Up (PMCF) Studies. It provides guidance regarding:

  • circumstances where a PMCF study is indicated
  • general principles of PMCF studies
  • design and implementation of PMCF studies, and
  • the use of information from PMCF studies.

Interested parties can comment on the consultation of this document until Friday, 11th of December 2020.


Singapore

The Medical Devices Branch of the Health Sciences Authority (HSA) is planning on implementing a UDI system for medical devices in Singapore. The first phase of the implementation will start in 2022 for high risk implantable devices to allow adequate preparation time for all stakeholders. But no Singapore specific UDI will be required. The UDI barcodes from the USA and EU that are based on the harmonized approach of the IMDRF will be accepted and the corresponding system will be implemented.


USA

Biocompatibility

The FDA published a draft guidance document for Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin. It describes the type of biocompatibility information that should be provided in a premarket submission for certain devices. The proposed sections in the daft document are intended to add or supersede applicable sections of the 2016 Biocompatibility Guidance. Anyone is free to submit comments by 14th of December 2020.


CDRH Guidance updates

The FDA’s Center for Devices and Radiological Health (CDRH) provided a list of guidance documents that they intend to publish in 2021. The CDRH is interested in receiving external feedback regarding whether guidances should be revised or withdrawn. The complete list is available under this link:


Cybersecurity

In the context of the National Cybersecurity Awareness Month the FDA summarized all the information about this topic and launched an introducing Cybersecurity Video.


The FDA developed a discussion paper about Communicating Cybersecurity Vulnerabilities to Patients: Considerations for a Framework. This document is being issued for discussion purposes only and is not a draft guidance. It provides best practices to consider when communicating with patients and caregivers about cybersecurity vulnerabilities.


The FDA has qualified the first Cybersecurity Medical Device Development Tool and has recognized the cybersecurity standard CVSSv3.0. The tool ‘RUBRIC FOR APPLYING CVSS TO MEDICAL DEVICES’ by The MITRE corporation is used for risk evaluation and communication between all stakeholders that are involved in a security vulnerability disclosure. The FDA's Medical Device Development Tools (MDDT) program is a way for the FDA to qualify tools that medical device manufacturers can use in the development and evaluation of medical devices.


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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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