EU EMC Medical Devices Directive (MDD)
UL can provide a direct local link for manufacturers declaring conformity to the EU Medical Device Directive through UL International (UK) Ltd.'s Notified Body status (0843) for the MDD. UL-UK's Notified Body status covers products under all annexes. In addition, UL-UK can assess all active medical devices and their non-sterile accessories.
UL can also assist with the MDD through a cooperative agreement with DGM, the Danish Notified Body for medical device certification, and the Danish Standards Association (DS). UL's DEMKO affiliate is one of seven major Danish organizations that make up DGM. UL offers complete EMC testing services for all medical devices, including:
- Comprehensive EMC testing to meet requirements for electronic and electrical products included in the EU EMC Directive performed to EN 60601-1-2 EMC Requirements for Medical Equipment
- Technical support in complying with the Manufacturer's Declaration and Guidance Documentation requirements of Section 6 of EN 60601-1-2
- Organizing technical documentation file support to clearly show compliance with the essential requirements of the MDD adding confidence and credibility to the manufacturer's declaration of conformity
- Detailed technical assistance to manufacturers in interpreting and applying requirements specified in the EU MDD annexes for medical and dental devices
- Preliminary audits, test preparation and concurrent product safety testing
- EMC evaluations for programmable electronic systems driving health and safety-related equipment, such as medical diagnostic and treatment devices, covered under the EU MDD
Additional resources
Learn more about UL's complete regulatory solutions for medical device manufacturers.
