EU Conformity Assessment Body services
Taking advantage of UL's European Union Conformity Assessment Body accreditation can help you further reduce your regulatory compliance costs. UL is the first U.S. Conformity Assessment Body (CAB) to pass the FDA's stringent on-site facility assessment and witnessed audit under the U.S.-EU medical device MRA.
As the United States' first CAB fully accepted by the EU, UL is ready to help you achieve your compliance and market access goals for Europe. UL offers the following medical CE assessment services:
- Class I (sterile or measuring) devices under annex V (sterile or measuring aspects)
- Class IIa devices under Annex II (full quality assurance) or V (production quality assurance)
- Class IIb devices under Annex II (full quality assurance)
- Class III (active medical devices) under Annex II (full quality assurance)
- Other assessment routes available on application
Located in your own backyard, UL can help you achieve timely acceptance of your product by EU Notified Bodies. Best of all, if you've already built a relationship with a European Notified Body, you can continue to work with that Notified Body for your final certification while taking advantage of UL's local resources for required audits and technical reviews. As a U.S. CAB, UL's work is required to be accepted by European Notified Bodies.
Note: Only Annexes II and V are available under the CAB program and there are certain restrictions on device type.
