October 5, 2021 Regulatory Updates
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Medical Devices – USA/Europe Regulatory Updates round up – Sep 2021

EUROPE

1. Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746

For class D devices, Article 48(6) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) establishes the conditions to be applied by the notified body to determine whether it has to consult the expert panel on the performance evaluation report of the manufacturer. These conditions are:

(1) The absence of common specifications for the class D device in question, AND
(2) Where it is also the first certification for that type of device.

This guidance provides clarification on the meaning of these conditions and on the corresponding procedures to be followed by the notified body.

  • What is the meaning of “the first certification for that type of device” in accordance with Article 48(6) of Regulation (EU) 2017/746?
  • What procedure should a notified body follow to determine whether a given certification is the first for that type of device?
  • How should the notified body indicate the type of device in its submission to the IVD expert panel?
  • What is the meaning of the phrase “where no CS are available” in Art 48(6)?
  • If a notified body identifies that a consultation of an expert panel is currently ongoing for that type of device, what should it do regarding the certification process?

2. Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

This guidance document is mainly focused on activities performed by notified bodies, providing also clarification on the quality management system they are expected to assess
A separate MDCG guidance document, in the form of Questions & Answers, is being developed to complement and address implementation of other relevant requirements for distributors and importers introduced by Article 16 of MDR / IVDR. A separate MDCG guidance document, in the form of Questions & Answers, is being developed to complement and address implementation of other relevant requirements for distributors and importers introduced by Article 16 of MDR / IVDR.

3. Unavailability of a medical device: the ANSM publishes a preventive management procedure for market operators

The French National Agency for Medicines and Health Products Safety (ANSM) has published advice on incoming procedures for preventing shortages of medical devices and diagnostics.

Like the drug shortage policy discussed by ANSM last week, the new policy will take effect at the start of next month and place additional requirements on providers of products that are deemed to be essential. ANSM has published a decision-making flow chart covering the procedure for dealing with shortages and potential shortages of essential medicines and in vitro diagnostics.

ANSM expects manufacturers to use all the means at their disposal to prevent shortages. Manufacturers that are unable to prevent a supply disruption need to report the situation to ANSM so that alternative solutions can be found. ANSM has created a form manufacturers can use to inform it of disruptions to supply.

4. Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices

This guidance document concerns performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices (IVDs) in the context of conformity assessment under Directive 98/79/EC or Regulation (EU) 2017/746. It covers devices for detection or quantification of SARS-CoV-2 nucleic acid, antigens and also detection or quantification of antibodies against SARS-CoV-2. These devices are collectively referred to as SARS-CoV2 IVDs. The guidance is addressed to all interested parties, including notably the manufacturers, as well as notified bodies and competent authorities, authorised representatives, other market operators, professional and patient associations.

The content of this guidance document is envisaged to form the basis for common specifications to be adopted according to Article 9 of Regulation (EU) 2017/746 in the coming months. The content may be adapted to take account of changing circumstances and increasing scientific and technical knowledge, as the COVID-19 pandemic continues to evolve.

5. MHRA shares guidance for manufacturers of temperature screening devices

MHRA has shared guidance for manufacturers of devices used to screen the temperature of people in the context of the COVID-19 pandemic.

The guidance states manufacturers that claim their products are intended to screen humans for fever, COVID-19 or other illnesses need to comply with regulations on medical devices. MHRA may regulate products with relevant claims even if the manufacturer includes disclaimers that they are not medical devices and cannot diagnose COVID-19.

MHRA typically regulates thermal cameras and digital thermometers intended for medical purposes as active medical devices. The agency categorizes active medical devices used to measure or monitor human body temperature as Class IIa products.

US FDA

6. FDA Export Certification

This guidance document is intended to provide a general description of Food and Drug Administration (FDA or the Agency) export certification to industry and foreign governments. Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply a certification relating to products subject to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and other statutes FDA administers.
This guidance supersedes the document issued under this title in July 2004, as corrected in April 2005 and February 2019.

7. FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency

FDA is issuing this guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity for the duration of the COVID-19 public health emergency. The appendix to this guidance further explains those general considerations by providing answers to questions that the Agency has received about conducting clinical trials during the COVID-19 public health emergency.

8. Notice: Interim order regulating certain UV radiation-emitting and ozone-generating devices under the Pest Control Products Act

The US Food and Drug Administration (FDA) is informing stakeholders and the public that it will soon begin implementing a court decision that may require the agency to transition some products approved as drugs to be regulated as devices.

In April, FDA lost a court battle (Genus Med. Techs., LLC v. FDA, 2021 U.S. App. Lexis 10928) in the US Court of Appeals for the District of Columbia Circuit when it argued it had the ability as a regulatory authority to classify some barium sulfate contrast imaging agents as drugs when they also met the definition of a device under the Federal Food, Drug, and Cosmetic Act. The classification of barium sulfate contrast agents, FDA explained, was “intended to be consistent with a previous court decision” and done so the agency could regulate all contrast imaging agents under an authority in the Center for Drug Evaluation and Research.

A major change in regulating imaging agents

The move is a major change for FDA because the agency has long regulated imaging agents as drugs, rather than devices, even though some imaging agents meet the definition of both a drug and a device. Imaging agents were regulated by FDA as drugs regardless of whether they serve as an enhancement for imaging devices like ultrasound, CT, MRI, and radiology devices, or are necessary to produce an image, such as in the case of radiopharmaceutical imaging.

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