Electric and electronic medical devices will have to fulfill the requirements laid down in the Electromagnetic Compatibility (EMC) Directive 2014/30/EU in addition to those described in the applicable medical devices Directives and Regulations.
EMC Compliance Process
- Appoint your European Authorized Representative
→ Ask for our quotation! - Identify all EU Directives/Regulations applicable to your product (such as environmental regulations etc.)
→ We will assist! - Identify the applicable harmonized standards for your product
→ We will provide a list! - Prepare a Technical File (including User Manual)
→ We will assist! - Select a Notified Body to perform the required Conformity Assessment tasks
→ We will provide addresses! - Prepare technical documentation in accordance with annex I
→ We will guide you through! - Prepare your Declaration of Conformity
→ We will provide forms!