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Page 18
05Feb 2024
EU, Brazil, FDA, General Information, IVD, Regulations, Swiss, UK, USA admin Comments: 0

Global ISO Requirements

What is ISO? ISO – International Organization for Standardization, is the international, non-governmental body for drafting and establishing technical and non-technical standards. These standards are developed by different committees within the International Organization for Standardization. Having around 165 member states, with one representative from each, International Organization for Standardization is a global entity catering to the needs of industry requirements. Are ISO standards impor...
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Global Labelling Requirements
05Feb 2024
EU, Blogs, FDA, General Information, Regulations, UK, USA admin Comments: 0

Global Labelling Requirements

Label, Labelling vs Instructions for Use (IFU)? 1. A Label is the written, printed, or graphic information that goes on the packaging of the medical device. 2. Instructions For Use (IFUs) or Package Insert is the essential information accompanying the medical device for its safe and effective use by the user. It can be a single to multiple-page document. 3. Labelling is the content that goes on the Label or IFUs. What are the minimum requirements for labeling? The ISO has published many standard...
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05Feb 2024
CDSCO, India, Regulations admin Comments: 0

CDSCO Registration Process

This guidance is applicable to manufacturers placed within India. Get detailed information about CDSCO registration process. Regulation Medical Devices Rules, 2017 Important Forms License to manufacturer Notified Medical Devices License in Form MD-5 or 6 for Class A or Class B Application  formForm MD-3 or 4  for Class A or Class BRule 20 Rule 20(4) and 20(6) for Class A or Class B State Drug Licensing Authority License to manufacturer Notified Medical Devices License in Form MD-9...
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05Feb 2024
EU, General Information, Regulations Cubicdesignz Comments: 0

Smart Wearables Regulations in the EU 

The booming technological aspects have constantly challenged regulations established worldwide in the modern century because the regulations either inadequately govern novel technologies, or there always exists a scenario where the devices cannot be categorized within a given regulation. Smart wearables are one of those aspects falling into such debate in recent times. Days are no longer from the fact that these smart wearables may draw strict regulations to be in place. How are these general we...
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05Feb 2024
EU, General Information, Regulations, UK Cubicdesignz Comments: 0

Exceptional Use Medical Devices in the EU and UK

Medical devices conforming with the medical device regulations must have a conformity marking. Medical devices that do not conform may still be placed in the market, provided they apply through the exceptional use devices pathway. This article discusses the exceptional use requirements to be satisfied to gain access to EU and UK markets. In the UK, the UKCA marking displays that the device conforms to UK Medical Device Regulations 2002. Without UKCA marking, the devices can only be placed in the...
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05Feb 2024
EU, Regulations Cubicdesignz Comments: 0

ISO 20417:2021 – Information to be supplied by the Manufacturer

Engineered medical devices are introduced to the market for use in clinical scenarios. From a user’s perspective, the safe and effective usage of a medical device is highly influenced by providing appropriate accompanying information with the device labels and user instructions. An international standard that defines the information to be supplied by the manufacturer of Medical Devices is ISO 20417:2021, with the latest version as ISO 20417:2021. Besides, ISO 15223 stands for requirements that...
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05Feb 2024
EU, Regulations, UK Cubicdesignz Comments: 0

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:   1. As a standalone medical device or   2. As a component of another medical device regulation.  The former demands a lengthy regulatory process that includes a conformity assessment to determine whether the medical device meets EU MDR requirements. However, that rule does not apply to products in...
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05Feb 2024
EU, Regulations Cubicdesignz Comments: 0

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 Application of EU MDR to legacy devices and Legacy device management for Legacy devices. There are three terminologies to guide the manufacturers – old devices, legacy devices and MDR devices. ‘Old devices’...
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05Feb 2024
EU, Regulations, Swiss, UK, USA Cubicdesignz Comments: 0

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 (PMS), risk assessment, post-market clinical follow-up (PMCF) plans and reports. The SSCP document is required for high-risk devices only-this includes Class III and all implantable devices. Manufacturers of custom-made or investigati...
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05Feb 2024
EU, Regulations Cubicdesignz Comments: 0

Regulatory Pathway for Clinical Investigation in the EU

Regulatory Pathway for Clinical investigation creates a set of clinical data that is crucial to understanding the effectiveness of a medical device. Clinical Investigation is done for previously CE marked devices or for research medical devices. Clinical Investigation is governed by a clinical investigation plan with an objective, methodology, and record keeping. Top 5 Steps involved in Clinical Investigation Step 1 Appointment of a Representative- Appoint a legal representative....
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