Certification of active medical equipment and software
Medical Device Regulation
Kiwa Dare B.V. is designated for the Medical Device Regulation (MDR) to perform conformity assessments for active (electronic) non-implantable medical devices.
Our scope includes a wide array of MD-codes which can be found in the database of the European Union (entry Kiwa Dare B.V. in the NANDO-database). After the designation for the MDD in 2015, the designation for the MDR was obtained in 2019, as the sixth Notified Body in Europe and the first in the Benelux.
How can we help you?
As a notified body, we can support you to obtain the CE-marking for your medical devices by certification based on product verification or combined assessment of quality management system and technical documentation. Our team of lead-auditors, TD-reviewers, internal clinician and the support team are ready and more than happy to provide this service to your company.
Medical Device Regulation (MDR)
The Medical Devices Regulation (EU) 2017/745 (MDR) applies to medical devices and their accessories. Medical devices are divided into different risk classes, as indicated in the MDR. As of May 26th, 2021 the MDR became in full force, and the MDD remains only valid during the transition period.
Approach to CE marking of your medical devices
As a manufacturer of medical devices there are two distinct ways that allow you to apply the CE marking to your medical devices.
- Certify your products: MDR Annex X and Annex XIB
- Certify your quality management system and technical documentation: MDR Annex IX or Annex XIA
Both approaches lead to CE marking of the medical devices, however the first approach is more suitable for single units or small batches while the second approach is more suitable for higher volumes and a larger portfolio or products.
The European Commission provides a step to step guide as an implementation model for the MDR, before starting the actual certification process, with the following 12 steps. Link to guide.
- Pre-assessment
- Gap analysis and actions resulting from this
- Quality Management System (QMS)
- Legel Entities
- Portfolio
- Master Implementation plan
- Notified Bodies
- Regulatory training
- Execute master implementation plan
- Review efficiency and effectiveness
- Notified Body submission
- Ongoing monitoring
Kiwa Dare plays an important role in step 7, 11 and 12 and can perform the conformity assessment process leading to certification.
Device identification
As a completely new feature, the MDR requires manufacturers to register all medical devices. For this a system of Unique Device Identifiers has been set up. At this moment manufacturers can already register themselves in the EUDAMED database.
Application certification medical devic
Kiwa Dare B.V. is accredited for the assessment of EN-ISO 13485: 2016 quality management systems (RvA system certification - C637). The EN-ISO 13485 assessments can be taken as a separate service or in combination with the MDR Annex IX / XIA. In the latter case, a separate certification for EN-ISO 13485 and the MDR is issued.
Kiwa Dare B.V. is also accredited for testing according to the medical device standard, the EN-IEC 60601, for both EMC and safety aspects. Experienced engineers conduct the tests and assessments in accordance with this standard.
Kiwa Dare B.V. is an independent operating company of Kiwa Nederland B.V. The company is financially independent and fully realizes its turnover with services for its customers.
Brochure
Download here the brochure Medical Certifications in PDF format.
Click on the links below for more detailed information:
Application
Public information
References
