M edical Device Clinical Evaluation  is a procedure to collect, assess, analyze a clinical data based on a clinical device to analyze whether there is sufficient clinical evidence to confirm compliance with essential safety and performance requirements when using according to manufacture instruction of is applicable to all classes of medical device based [...]

By |2023-03-28T11:30:05+00:00August 7th, 2022|EU CE|Comments Off on MEDICAL DEVICE CLINICAL EVALUATION : AN OVERVIEW

Medical Device Labelling

Medical Device Labelling: A label is the written, printed, or visual information that appears on the medical device itself, as well as the packaging of individual units or numerous medical devices. To avoid non-compliance, manufacturers must ensure that their product labels include all of the following elements: Name of the device The serial number [...]

By |2021-12-20T12:26:50+00:00September 2nd, 2021|EU CE|Comments Off on Medical Device Labelling

User Manual Requirements for Medical Devices

A information supplied by the manufacturer to inform the user of a product's intended purpose and appropriate use is referred to as "instructions for use." The following items must be present in the information provided with the directions for use: Information in line with Section 23.2 of the MDR points (a), (c), (e), (f), [...]

By |2021-12-14T10:51:30+00:00July 2nd, 2021|EU CE|Comments Off on User Manual Requirements for Medical Devices

Single Registration Number (SRN)

What exactly is a Single Registration Number (SRN)? The Single Registration Number (SRN) is a unique code that is used to identify an economic operator in the EU without ambiguity. The SRN number is generated by EUDAMED and issued by the competent authority who validated the Actor registration request in EUDAMED. Manufacturers must apply [...]

By |2022-07-13T05:37:34+00:00July 2nd, 2021|EU CE|Comments Off on Single Registration Number (SRN)

Eudamed Actor Registration

EUDAMED is the European Medical Device Databank. It's a safe, web-based portal that serves as a hub for information exchange between national authorities and the European Commission. The portal is not accessible to the public. EUDAMED came into force in May 2011 intending to improve market surveillance and transparency in the setup of medical [...]

By |2022-05-14T10:00:10+00:00July 2nd, 2021|EU CE|Comments Off on Eudamed Actor Registration

Attributes of Biological Evaluation

B Biological Evaluation is estimation of biological responses of the product to ensure safety and efficacy with patient and user. Biological Evaluation of Medical Devices is a series of tests performed with the help of international standards pre-clinically either through In-vitro or In-vivo techniques and may upon animal models to assess the biological safety [...]

By |2021-12-14T11:06:54+00:00June 22nd, 2021|EU CE|Comments Off on Attributes of Biological Evaluation
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