Regulations
Top 7 Guidance On Class I Medical Devices
Before marketing their medical devices in Europe, manufacturers must comply with EU Medical Device Regulations (EU MDR 2017/745). MDR ensures that manufacturers meet specific regulatory requirements, and manufacturers of Class I are not exempted from these. This article provides guidance for Class I medical device manufacturers.
Annex XVI – EU MDR
The new Medical Devices Regulation (MDR), which came into effect on May 25, 2017, controls some kinds of devices that are not designed for medical use and are categorised in Annex XVI. These products, like all other medical devices, are required to comply with the MDR’s obligations by the 26th of May 2020.
SaMD Devices Classification
SaMD is software intended for one or more medical purposes that perform these without being part of a hardware medical device. Medical device software is meant to be used, alone or in combination, for a purpose specified in the definition of a “medical device” in the...
Field Safety Corrective Action (FSCA) – Swiss
What is a Field Safety Corrective Action? Any action performed to reduce the risk of death or serious deterioration in health connected with the use of a medical device is referred to as Field Safety Corrective Action (FSCA). The manufacturer is required to take...
Regulatory Pathway for Clinical Investigation In the UK
Clinical Investigation of medical devices follows a different regulatory pathway. A clinical investigation is a systematic study of one or more humans to evaluate a medical device’s safety, clinical performance, and overall effectiveness. Clinical investigation plays a massive role in patient safety. This article is based on the document on Notification of MHRA about a clinical investigation for a medical device.
Regulatory Pathway for Clinical Investigation in the EU
Clinical Investigation of medical devices follows a different regulatory pathway. A clinical investigation is a systematic study of one or more humans to evaluate a medical device’s safety, clinical performance, and overall effectiveness. Clinical investigation plays a massive role in patient safety. The information regarding this article is taken from the guidance documents released by the Medical Device Coordination Group (MDCG).
Summary of Safety and Clinical Performance (SSCP)
Summary of Safety and Clinical Performance (SSCP) acts as a vital document that allows the public to access information quickly. The information in the SSCP can be sourced entirely from the technical file. The technical file consists of the Post Market Surveillance...
LEGACY MEDICAL DEVICES REQUIREMENTS IN EUROPE
Legacy medical devices include all previously regulated devices under the Medical Devices Directives (MDD 93/42/EEC 90/385/EEC) and In-vitro Diagnostic Devices Directive (IVDD 98/79/EC). Medical Device Coordination Group (MDCG) published the guidance documents on the...
Field Safety Corrective Action (FSCA) – US FDA
What is Medical Device Reporting? Medical Device Reporting (MDR) is one of the FDA's post-market surveillance techniques for monitoring device performance, detecting potential device-related safety concerns, and contributing to device benefit-risk assessments. There...
7 SaMD Device Regulation (UK & Europe)
Under both the EU MDR and the EU IVDR, the MDCG rules specify the conditions for a product to qualify as medical device software (MDSW). An MDSW product can enter the market in one of the ways: As a standalone medical device or As a component of another...