Application Certification MDR
Apply here for certification of your active Medical Devices
The CE marking of class I - measuring, class I - sterile, IIa, IIb, and III medical devices must be performed in collaboration with a Notified Body. Kiwa Dare B.V., trade name Kiwa Dare is designated for the Medical Device Regulation (MDR) to perform conformity assessments for active (electronic) non-implantable medical devices.
Kiwa Dare is designated to perform the following conformity assessment types under the MDR:
- Annex IX - Conformity Assessment Based on a Quality Management System and on Assessment of Technical Documentation
- Annex X - Conformity Assessment Based on Type-Examination
- Annex XI part A - Conformity Assessment Based on a Product Conformity Verification, Part A Production Quality Assurance
- Annex XI part B - Conformity assessment based on product conformity verification, Part B Product Verification
Annex IX and Annex XI part A certifications can be combined with a EN-ISO 13485 certification. Kiwa Dare is EN-ISO/IEC 17021-1 accredited for EN-ISO 13485 certifications.
Kiwa Dare is also designated to perform Annex II (Full quality assurance system), Annex III (EC Type – examination) and Annex IV (EC Verification of products and batches) and Annex V (Production quality assurance) conformity assessments under the MDD.
Use the form below to apply for the certification of your active (electronic) non-implantable medical device. You will receive an information package illustrating the procedure to be followed and we will contact you soon. You can also discuss in an introductory (telephone) meeting if Kiwa Dare is designated to certify your medical device. For the official application of MDR or EN-ISO 13485 certification you are requested to fill in our application form and sign our certification agreement.