EUROPE
1. Clarification on “First Certification for That Type of Device” under Article 48(6) of IVDR
For Class D in vitro diagnostic medical devices, Article 48(6) of the IVDR requires notified bodies to consult the expert panel when:
- No common specifications exist for the device, AND
- The certification is the first for that specific type of device.
The guidance clarifies:
- How “first certification for that type of device” should be interpreted
- The procedure for determining whether a certification qualifies as “first of its type”
- How the device type should be described in submissions to the IVD expert panel
- The meaning of “where no common specifications (CS) are available”
- The appropriate steps when an expert panel consultation is already underway for a similar device
2. Guidance for Notified Bodies, Distributors, and Importers under Article 16(4) of MDR/IVDR
This guidance focuses on the activities of notified bodies and clarifies expectations for quality management system (QMS) assessments related to relabelling and repackaging.
Additional MDCG Q&A guidance is being drafted to further address distributor and importer obligations introduced under Article 16 of MDR/IVDR.
3. ANSM Publishes Preventive Management Procedure for Device Shortages
The French medicines and health products agency (ANSM) has introduced a preventive process for managing shortages of medical devices and diagnostics.
The new requirements include:
- A decision-making flowchart for addressing actual or potential shortages
- A mandate for manufacturers to use all available means to avoid shortages
- A reporting obligation when supply disruptions cannot be prevented
ANSM has also created a reporting form for manufacturers to notify the agency of shortages.
4. Guidance on Performance Evaluation of SARS-CoV-2 IVDs
This guidance covers conformity assessment requirements for SARS-CoV-2 in vitro diagnostic devices (nucleic acid tests, antigen tests, and antibody assays) under the IVDD and IVDR.
It outlines performance evaluation principles and is expected to serve as the basis for future common specifications under Article 9 of the IVDR. The document may be revised as scientific knowledge and the pandemic evolve.
5. MHRA Guidance for Manufacturers of Temperature Screening Devices
MHRA reminds manufacturers that temperature screening products marketed for fever or illness detection fall under medical device regulation.
Key points include:
- Relevant claims trigger regulation even if the manufacturer states the product is “not a medical device”
- Thermal cameras and digital thermometers intended for medical purposes are typically classified as Class IIa active medical devices
- Manufacturers must demonstrate compliance with applicable regulatory requirements
UNITED STATES (FDA)
6. FDA Export Certification Guidance
FDA has updated its guidance on export certification for products governed by the FD&C Act.
The document explains:
- Types of export certificates issued
- When certificates are required by foreign governments
- How firms may request them
This version replaces earlier editions from 2004, 2005, and 2019.
7. FDA Guidance on Conduct of Clinical Trials During the COVID-19 Public Health Emergency
This guidance helps sponsors maintain trial integrity and good clinical practice (GCP) compliance during the pandemic.
It includes:
- Considerations for participant safety
- Flexibilities in protocol modifications
- Answers to frequently asked questions
- Expectations for documentation of COVID‑related impacts on trial conduct
8. Notice on Regulation of UV Radiation–Emitting and Ozone‑Generating Devices
FDA is preparing to implement a court decision that may require reclassification of certain products historically regulated as drugs.
The ruling (Genus Medical Technologies LLC v. FDA) determined that some barium sulfate contrast agents should be regulated as devices when they meet the statutory definition.
This decision may affect oversight of various imaging agents long overseen as drugs, including those used with CT, MRI, ultrasound, radiology, and radiopharmaceutical imaging modalities.
