RELATED INFORMATION

Amendment to Regulation (EU) 2017/746 concerning transitional provisions for certain in vitro diagnostic medical devices and the deferment of the application of conditions for internal devices.

MDR 2017/745 has a total of 10 chapters with 123 articles, 17 appendices. (while MDD 93/42/EEC has 23 articles and 12 annexes).

The Low Voltage (LVD) Directive EC: 2014/35/EU provides a high level of protection for European citizens within certain voltage limits and applies to the European market and elsewhere in the world

The ISO 14000 family of standards has many standards of which ISO 14001 is the central standard.

On 17 May 2006 the European Commission issued the latest Machinery Directive (2006/42/EC).

Which medical equipment and personal protective equipment need CЄ Marking certification to be eligible for export to the European market? What is the process, procedure, and cost to get the COR certificate?

ISO 9001 (short for ISO 9001:2015 - this is the latest version of the current ISO 9001 standard) is a Quality Management System standard developed and published by the International Organization for Standardization September 24, 2015.

ISO 13485 is an international standard developed by the ISO international organization in the field of medical device product quality and safety, this standard has a close relationship with the ISO quality management system certification standard.

This is Information Security Management Systems (English name: Information Security Management Systems): ISO 27001 is a guiding standard for Information Management.