CE Marking

Introduction of Medical Devices into the European Union (EU), requires CE Marking. The CE Marking is the certification that the device complies with the applicable MDR/IVDR and that it is safe for the user. 

All Medical Device Manufacturers in the EU must meet MDR 2017/745 requirements regarding CE Marking in order to market products in Europe. Orderly People can support you, regardless of Product Classification and the size of your company, with the CE approval process for both Medical Devices and IVD products. 

In addition to that, Orderly People also supports you with:

• Identify the appropriate regulatory assessment route and structure for your company and the applications required to achieve the CE Marking

• Support and/or  Project Manage the Technical Documentation establishment

• Review of the General Safety and Performance Requirements, GSPR

• Guidance, update and follow-up on Risk Management in accordance with ISO 14971.

• Ensure an effective Post Market Surveillance process, PMS