Medical Devices – USA/Europe Regulatory Updates round up – Aug 2021

EUROPE

1. Clarification on “first certification for that type of device” and corresponding 1. Clarification on “First Certification for That Type of Device” and Related Procedures for Notified Bodies under Regulation (EU) 2017/746

Article 48(6) of Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) outlines the conditions under which a notified body must consult the expert panel regarding the performance evaluation report of the manufacturer for class D devices. The two key conditions are:

1.  The lack of common specifications (CS) for the specific class D device, and
2. The certification being the first for that particular device type.

This guidance clarifies what constitutes “first certification” and provides the steps that notified bodies should follow when determining if the certification qualifies as the first for that device type. It also details how the notified body should submit information to the IVD expert panel, and the procedure to follow if there is an ongoing consultation for that device type.

2. Guidance on Certification Activities under Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 for Notified Bodies, Distributors, and Importers

This guidance document primarily focuses on activities carried out by notified bodies, with emphasis on the quality management system that they are expected to assess. Additional MDCG guidance in the form of Q&A will be developed to address the implementation of Article 16 of the MDR and IVDR for distributors and importers.

3. Procedure for Managing Medical Device Shortages: ANSM’s Preventive Management Strategy

The French National Agency for Medicines and Health Products Safety (ANSM) has introduced a preventive management procedure for addressing medical device shortages. The policy, which will begin next month, sets additional requirements for essential product providers. A decision-making flowchart outlining the procedure for managing device shortages has been published. Manufacturers are expected to take all possible steps to avoid supply disruptions and must notify ANSM if disruptions occur, allowing alternative solutions to be explored.

4. Performance Evaluation of SARS-CoV-2 In Vitro Diagnostic Devices

This guidance provides recommendations for evaluating the performance of SARS-CoV-2 in vitro diagnostic medical devices (IVDs), including tests for SARS-CoV-2 nucleic acid, antigens, and antibodies. The guidance aims to help manufacturers, notified bodies, and authorities with conformity assessments under Directive 98/79/EC or Regulation (EU) 2017/746. It also outlines the upcoming common specifications for SARS-CoV-2 IVDs, which may evolve based on scientific developments and the ongoing pandemic.

5. MHRA Guidance for Manufacturers of Temperature Screening Devices

The MHRA has issued guidance for manufacturers of temperature screening devices, particularly in the context of COVID-19. The guidance specifies that products intended for human fever screening must comply with medical device regulations, even if the manufacturer claims the device is not a medical device. Thermal cameras and digital thermometers intended for medical use are classified as active medical devices and typically fall under Class IIa.

US FDA

6. FDA Export Certification

This document outlines the FDA’s export certification process, providing information on how U.S. firms can supply certification for medical products to foreign customers or governments. It supersedes previous guidance issued in 2004, with updates reflecting current regulatory practices.

7. FDA Guidance on Clinical Trials During the COVID-19 Public Health Emergency

The FDA has released guidance for sponsors on conducting clinical trials during the COVID-19 public health emergency. The guidance focuses on ensuring the safety of trial participants, maintaining compliance with good clinical practices (GCP), and protecting the integrity of trials amidst the pandemic. The appendix provides detailed responses to frequently asked questions related to trial conduct during this period

8. Interim Order on UV Radiation-Emitting and Ozone-Generating Devices under the Pest Control Products Act

The FDA will implement an interim order requiring certain UV radiation-emitting and ozone-generating devices to be regulated as medical devices. This follows a court ruling that challenged the FDA’s previous classification of some imaging agents as drugs, even though they met the definition of both a drug and a device. The change in regulatory approach will impact how contrast agents are managed by the FDA moving forward.