Certain types of devices must also fulfill the requirements laid out in the Directives for electrical equipment. More specific details can be found in the sections EMC and LVD below.
EMC – Electromagnetic Compatibility Directive No. 2014/30/EU
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!
LVD – Low Voltage Directive
Are you unsure whether your devices fall under the Low Voltage Directive 2014/35/EU (LVD)? We can help you to find out and identify the necessary steps together with you.
LVD 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! - Implement a Quality Assurance System (in accordance with annex III of the LVD)
→ We will guide you through! - Prepare Technical File (in accordance with annex III of the LVD)
→ We will assist! - Select a Notified Body, if applicable (depends on the type of your product)
→ We will provide addresses! - Prepare your Declaration of Conformity
→ We will provide forms!
