What is UKCA Marking? The United Kingdom Conformity Assessed marking, or UKCA Marking is only legal in the United Kingdom. It was implemented in response to Brexit and went into effect on January 1, 2021. Manufacturers must adhere to the recommended UK product labeling in order for their items to be sold in Great Britain.…
Cyber Security Plan for Software as Medical Device(SaMD) become more competent in accessing, analyzing, communicating, and automation to improve the speed and quality of patient care. However, advancements with technological advances arise new risks and concerns. The risk of threats in both network and software is unavoidable through hackers. To assist manufacturers in developing adequate…
Pre-Clinical Vs Clinical Data Pre-clinical data are the vital testing and safety data collected during the research stage before the clinical trials begin. Tests like in-vitro tests, ex-vivo tests, biological evaluation, simulated use, engineering, performance tests, animal tests, computer modelling, lab tests, stability, shelf life etc. come under pre-clinical tests. Clinical data are used to…
Medical Device Classification The new MDR 2017/745, which came into effect on 26 May 2021, categorizes medical devices into classes: Class I, Class II a, class II b, and class III. This classification is based on the 22 rules in the new MDR 2017/745. Rules 1-4 for Non–invasive devices, rules 5-8 for Invasive devices, rules 9…
EN ISO 10993-18 ( CHEMICAL CHARACTERIZATION OF MEDICAL DEVICE ) Chemical characterization is a crucial step in evaluating the biocompatibility of a medical device. It is done to identify and characterize the chemical constituents (extractable and leachable) which could disclose biological risks to patients and medical practitioners. Extractables are substances that can be…
MDR LABELLING REQUIREMENTS [A] NON-ACTIVE MEDICAL DEVICES Information on the Label Name or trade name of the device. Necessary details for a user to identify the device, the contents of the packaging, and the intended purpose of the device. The name, registered trade name or registered trademark, and the address of its registered…
In the NAMSA’s website, it is stated that the biological safety testing or evaluation is conducted by characterizing medical devices based on nature and duration of body contact, assessing the selection of raw materials used for construction, reviewing the manufacturing processes, identifying minimum biological end-points of concern and evaluating any existing research data available for…
Benefit Risk Analysis: When the overall residual risk remains unacceptable and further risk control is not practicable, then there would be a need for risk-benefit analysis. In a risk-benefit analysis, a manufacturer shall review data and literature to determine if the medical benefits of the intended use outweigh the overall residual risk and hence a…
Clinical Evaluation of Standalone Software: Standalone software with a medical purpose is considered an active medical device, according to the EU MDD/MDR and the UK MDR. The danger to the patient and the users determines the classification. You’ll need to examine the appropriate categorization criteria to categorize your programme thoroughly. The importance of computer applications…
Clinical Evaluation of Equivalent Devices What extent of data on medical devices from other manufacturers does needed to demonstrate equivalence? FOR INSTANCE, Annex XIV (3) EU MDR refers to non-implantable devices of risk classes I – IIb. It specifies that manufacturers must provide clear evidence that they have sufficient access to the device’s data with…