LL-C CERTIFICATION Body is the LL-C (Certification Organisation) of the Czech Republic (https://ssl.ll-c.cz), authorized by the authorities recognized in the World.
Main activities of LL-C:
* Notified Body No. 2435
• Product certification
• System certification
• Evaluation service
• Training service (ERCA, EN ISO17024)
* Notified EU No. 2435 for CE Certification
• Regulation of building materials (CPR 305/2011/EU)
• Industrial machinery (MD 2006/42/EC).
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?
