March 7, 2022 Regulatory Updates

Medical Devices – USA/Europe Regulatory Updates Roundup, Feb 2022


MDCG 2022-3 – Verification of manufactured class D IVDs by notified bodies

This document aims to provide guidance to notified bodies to clarify their role and responsibilities in relation to samples of manufactured class D devices or batches of devices in accordance with Annexes IX and XI of the IVDR.

It also includes guidance on:

  • relevant information to be included within the notified body’s procedures,
  • the content of the required pre-agreed conditions and detailed arrangements between the notified body and the manufacturer,
  • guidance on the frequency of samples of devices or batches of devices to be sent to the EURL

Updated – Joint implementation Plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the IVDR

This new framework sets high standards of quality and safety for medical devices and aims at ensuring the smooth functioning of the internal market.

The priorities are split into two sets. Set A includes actions that are vital for devices to have access to the market (those related to a framework for contingency planning and availability of notified bodies). Set B includes legislation and guidance documents that, while not obligatory, would greatly facilitate the work of the actors as well as designation of EU reference laboratories for high-risk IVDs.

MDCG 2022-4 – Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR

This guidance document outlines the activities to be performed by notified bodies as part of the appropriate surveillance defined in Article 120 (3) second subparagraph MDR. In order to clarify elements to be verified by notified bodies, this guidance document also covers requirements concerning certain manufacturers’ obligations, especially in respect to their quality management system guidance.


Guide to Classification of a Medical Device

This guidance relates to the qualification of medical devices and the application of the classification rules and related. It outlines the process for classifying medical devices and explains how to seek clarification on classification of a medical device. This guide sets out, inter alia, the reasons for classification and the routes to correctly qualify or classify a product under the Medical Device Regulation 2017/745 (MDR).


The AEMPS launches a new RPS for the registration of those responsible for placing medical devices on the market

On the occasion of the improvement and updating processes of its telematic applications, the Spanish Agency for Medicines and Health Products (AEMPS) launches a new RPS that facilitates the registration of those responsible for placing health products on the market, and which replaces the current platform.


Updates to list of medical devices for mandatory shortage reporting: Notice

This notice is to inform license holders that the List of Medical Devices – Notification of Shortages was updated on February 10, 2022, to include additional medical devices that require mandatory reporting by manufacturers and importers. Health Canada maintains and regularly updates this list, which is incorporated by reference (IBR) in Interim Order no. 2 (IO no. 2).

Under IO no. 2, manufacturers and importers must report shortages of specified medical devices (including their components, accessories or parts) to Health Canada.

For more information, please find the link below.

Regulations to allow exceptional importation of medical devices to address shortages as of March 2, 2022

Medical Devices Compliance Program Bulletin

Amendments to the Medical Devices Regulations (MDR), published in Canada Gazette, Part II in September 2021, come into force on March 2, 2022. The amendments will allow for the exceptional importation and sale of medical devices to help address shortages in Canada.

Publication of third Interim Order respecting the importation and sale of medical devices (COVID-19): Notice to manufacturers, purchasers and users

Health Canada has introduced Interim Order No. 3 on the importation and sale of medical devices for use in relation to COVID-19 to accelerate access to certain medical devices in Canada.


MDR Data Files

The FDA makes medical device reports available to patients and health care providers on the FDA’s public Manufacturer and User Facility Device Experience (MAUDE) database as one source of information to help them make more informed medical decisions.

For more information, please find the link below.

At-Home OTC COVID-19 Diagnostic Tests

These at-home COVID-19 diagnostic tests are FDA authorized for self-testing at home (or in other locations). Authorized at-home OTC tests are available without a prescription and are typically available online or at local retailers.

For more information, please find the link below.

Quality System (QS) Regulation/Medical Device Good Manufacturing Practices

The FDA published a proposed regulation, requesting public comment, to amend the device current good manufacturing practice requirements of the Quality System (QS) regulation (21 CFR Part 820) to incorporate the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes.

For more information, please find the link below.

Proposed Rule: Quality System Regulation Amendments – Frequently Asked Questions

Frequently asked questions regarding Quality System Regulation Amendments

Medical Devices; Quality System Regulation Amendments

The Food and Drug Administration is proposing to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation to align more closely with the international consensus standard for devices by converging with the quality management system (QMS) requirements used by other regulatory authorities from other jurisdictions.

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