Medical Devices

Medical Devices Directive

The Medical Devices Directive applies to medical devices and their accessories. For the purposes of this Directive, accessories are treated as medical devices in their own right. Medical devices are divided in classes which are treated in a different ways as defined by the Directive. The Directive defines essential requirements as well as requirements regarding design and construction.

Medical Devices Directive

The Dutch ministry of Health, Welfare and Sport has designated DARE!! Medical Certifications as Notified Body to carry out conformity assessments according to the Medical Devices Directive 93/42/EEC. See the official publication in the Staatscourant of the Netherlands for the decision of the ministry to designate DARE!! Medical Certifications. The designation is also noted in the NANDO-database of the European Commission.

The designation relates to active medical devices in accordance with Annex II, Annex III, Annex IV and Annex V of the MDD. For the MD codes for which DMC is designated, see our scope.

As a requirement for Annex III and IV, DARE!! Medical Certifications is accredited to perform certifications of active medical devices (RvA product certification - C447). In addition, DARE!! Medical Certifications is an accredited certification body for Quality Management Systems according to ISO 13485:2016 (RvA system certification - C637). The ISO 13485-assessments can be performed as separate service or in combination with MDD Annex II assessments. In the last situation, separate certificates for ISO 13485 and for Annex II will be granted.

DARE!! Measurements is also accredited for testing conform the standard for Medical Electrical Equipment (EN 60601) for EMC and safety aspects. Experienced engineers perform the tests and examinations conform this standard.

DARE!! Medical Certifications distinguishes itself by short waiting times and flexible planning of tests, conformity assessments and certification. Our efficient working method allows us to offer these services for attractive prices and, therefore, ensuring an excellent price-quality ratio. This is why many high reputable companies already make use of the services of DARE!! Medical Certifications.

Please note, in some cases of MDD conformity assessment, a manufacturer is obliged to submit clinical research with patients prior to the start of the research to the Health Care Inspectorate (IGJ). 

DARE!! Medical Certifications is an independent operational company realising its profit completely with services to customers.

Leaflet

Download the Medical Certifications® leaflet here in pdf format.

References

DARE!! Medical Certifications performs conformity assessments conform the Medical Devices Directive for several manufacturers, such as:

  • Meditop
  • Nemo Healtcare
  • Dermasun