EUROPE (EU)
Public health: Stronger rules for placing medical tests on the market
New rules on in vitro diagnostic medical devices (IVDR) such as HIV tests, pregnancy tests or COVID-19 tests will be applicable. The rules will better protect public health and patient safety in respect to these devices, bringing EU law in line with technological advances and progress in medical science. By aligning market access requirements in the different EU Member States, it also safeguards fair market access for manufacturers.
MDCG 2022-10 – Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746
This Q&A intends to clarify certain interfaces between the Regulation (EU) No 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). 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.
Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices
The new Regulation (EU) 2017/746 on in vitro diagnostic medical devices becomes applicable on 26 May 2022, replacing Directive 98/79/EC. For in vitro diagnostic medical devices placed on the market after 26 May 2022, Swiss manufacturers and third country manufacturers whose authorized representative was previously established in Switzerland must designate an authorized representative established in the EU.
MDCG 2022-8 – Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022
The new timelines are set out in a guideline covering legacy devices that are placed on the market before May 26, which is the date the transition period from the current IVD Directive (IVDD 98/79/EC) ends. A legacy device is either: a device with an EC certificate issued by a notified body under Directive 98/79/EC on in vitro diagnostic medical devices (IVDD) prior to 26 May 2022; or one for which the conformity assessment procedure pursuant to the IVDR requires the involvement of a notified body.
MDCG 2022-9 – Summary of safety and performance template
The Summary of Safety and Performance (SSP) is intended to provide public access to an up-to-date summary of the main aspects of the safety and performance of the device. The SSP is not intended to replace the Instructions for Use as the main document to ensure the safe use of the device, nor is it intended to provide diagnostic or therapeutic suggestions to intended users.
MDCG 2022-7 – Q&A on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746
The Document covers questions regarding UDI device identifiers (UDI-DI), UDI labeling, UDI rules for systems and procedures packs and configurable devices, and whether UDI rules apply to retail point of sale, promotional packs and marketing samples. The guidance addresses whether new UDI-DIs are required for device packaging changes, such as changing the number of devices in a package from five to ten. MDCG specifies that these changes would necessitate a new UDI-DI, stating that “a change in pack quantity would lead to a misidentifying of the device in this case and may cause traceability issues where incidents occur.”
IRELAND (HPRA)
In Vitro Diagnostic Medical Devices Regulation comes into effect in the EU today
Regulation (EU) 2017/746, known as the In Vitro Diagnostic Medical Devices Regulation (IVDR), comes into effect in the European Union today, 26 May 2022. For information on Key changes to ensure safety and effectiveness of IVDs check the below link.
UK (MHRA)
Notify the MHRA about a clinical investigation for a medical device
This guidance document provides information about how to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
USA (MHRA)
Microbiology Devices; Reclassification of Human Immunodeficiency Virus Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests
The FDA is issuing a final order to reclassify certain human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and HIV nucleic acid (NAT) diagnostic and supplemental tests, post amendments class III devices with the product code MZF, into class II (special controls), subject to premarket notification.
Feasibility and early feasibility Clinical Studies for certain Medical Devices intended to therapeutically improve Glycemic control in patients with Type 2 Diabetes Mellitus
The purpose of this document is to provide the FDA’s recommendations for feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic control in patients with Type 2 Diabetes Mellitus (T2DM). These medical devices are intended to therapeutically reduce glycated hemoglobin (HbA1c) in T2DM patients independent of medication (e.g., insulin) delivery.
FDA permits Marketing for new test to improve Diagnosis of Alzheimer’s Disease
The U.S. Food and Drug Administration has permitted marketing for the first in vitro diagnostic test for early detection of amyloid plaques associated with Alzheimer’s disease. The Lumipulse G β-Amyloid Ratio (1-42/1-40) test is intended to be used in adult patients, aged 55 years and older, presenting with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.
