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EU
Understanding Borderline Cosmetics in the EU
Understanding the distinctions between product classes within the European cosmetics landscape can be complex and ambiguous, often requiring input from authoritative bodies. Certain products may share similarities but fall under different regulatory frameworks. When products straddle these frameworks, they’re termed “borderline” by the European Commission (EC). Clear comprehension of a product category is vital to determine the regulatory requisites for the specific market. Dif...
EU Publishes New Regulation to Address In Vitro Diagnostic Device (IVDD) Shortages: Key Updates and Recommendations for Manufacturers
On July 9, 2024, Regulation (EU) 2024/1860 was published in the Official Journal of the European Union (OJEU) and took effect immediately. This new regulation aims to address the expected shortages of in vitro diagnostic medical devices (IVDs) in the EU due to the slower-than-expected transition from the In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR). Following the removal of the sell-off provisions in Article 110.4, made official with Regulation (EU) 202...
The ‘Blue Guide’ on EU product rules implementation 2022
The amended ‘Blue Guide’ on the application of the product rules 2022’ (“Blue Guide”) was released by the European Commission on June 29, 2022. The Blue Guide allows a better understanding of EU product regulations and their uniform and coherent application across various sectors throughout the EU single market. The Blue Guide has undergone significant changes, including the definition of new terms, the addition of information on which economic actors will be responsible for compliance...
Risk Management of medical devices under MDR
All medical devices are associated with inherent risks of some level. It is imperative to understand the medical device’s specific risks to a patient. Under EU MDR 2017/745, risk management is a continuous and iterative process. Manufacturers are expected to plan, document, and implement risk management strategies in this process. These strategies may either eliminate the risk or mitigate the overall severity of the risk. Medical Device Risk- Definition ...
Cybersecurity for medical devices in Europe
EU Cybersecurity laws for Medical devices are advancing, and the use of software medical devices is also increasing daily. The increased interconnection of medical devices to computer networks and technological convergence have made devices and software programmes vulnerable to mishaps. The importance of protecting patient data from cyber-attacks is now well recognised. With the advancement of software as a medical device, proper regulations must be established to ensure the safety and security...
EU MDR – Language Requirements
October 2021. The EU MDR 2017/745 brings more safety to the device in the European market. As part of the Safety measure for the largest medical device market in the world EU Union has made measures to make sure the product sold in the EU market is accessible for everyone at the same time is safe and traceable at every stage of the product lifecycle. The new regulation has made measure that a professional user as well as a lay person can understand the correct usage of the devic...
In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746
The IVD medical devices Regulation (EU) 2017/746 (IVDR) brings EU legislation into line with technical advances, changes in medical science, and progress in law-making. The new Regulation creates a robust, transparent, and sustainable regulatory framework recognised internationally, improving clinical safety and creating fair market access for manufacturers. In contrast to the previous Directive, the new Regulation is directly applicable and does not need to be transposed into na...
Electronic Instructions For Use Of Medical Devices
Commission Regulation (EU) No 207/2012 on electronic instructions for use of medical devices was published on 9 March 2012 and came into effect on 1 March 2013. There are 10 articles in this regulation. It establishes certain requirements for the “instructions for use” for the user that must be noted by the manufacturer of the device, to ensure proper and safe use of the device as well as to know about the precautions while using the device. It is meant to reduce potential risks as much...
Annex XVI – EU MDR
What is an Annex XVI product? Annex XVI products are those for which a manufacturer claims only an aesthetic or another non-medical purpose but are like medical devices in terms of functioning and risk profile. These categories of products were added in the new Regulation to establish production and surveillance standards for these previously unregulated products to protect users’ health and safety. LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2) When...
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