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Industrial and mechanical
Basics of the Medical Device Classification System
Discover what are the fundamental characteristics of the Medical Device Classification System.
Ongoing process for the revision of the Machinery Directive
European Commission's revision of EU Machinery Directive expected in the second quarter of 2021. It's set to clarify definitions of new digital technologies.
Which products fall under Personal Protective Equipment Directive PE 89/686/EEC
European Personal Protective Equipment Directive 89/686/EEC sets out a new categorization system for PPE products calling under the directive.
Regulation (EU) 2016/1628 – Pollutant limits in non-road machinery
Find out more about the products and vehicles affected by EU Regulation 2016/1628/EU relating to gaseous and particulate pollutant emission limits in Europe
New references of harmonised standards
New references of EU harmonised standards published for personal protective equipment, machinery, ATEX, construction points, pressure equipment, and more.
Ex-vivo tests: cosmetics without human testing
Find out more information on the European Directive increasing the safety requirements for cosmetic products.
Not only UVA and UVB
The use of screens, smartphones and tablets expose the skin to blue light, that can lead to health issues. Find out how cosmetics can protect from blue and infrared light.
The impact of the new MDR and IVDR Regulations on Notified Bodies
The new MDR (2017/745) and IVDR (2017/746) will replace the EU’s current Medical Device Directive (MDD) (93/42/EEC) and In Vitro Diagnostics Directive (IVDD) (98/79/EC) to establish a more robust EU legislative framework and ensure better protection of public health and patient safety.
The PPE Regulation countdown is about to start
Learn all you need to know about EU PPE Regulation 2016/425 before it enters full effect on April 21st 2018. Talk to Obelis' experts about your compliance.