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The certification body for the dental field |
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Nordic Dental Certification |
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Routes to C-marking |
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General requirements The Medical Device Directive (MDD) requires that manufacturer has a vigilance system, post marketing surveillance/recall system, and performs a risk analysis combined with documentation of how each product fulfills the Essential Requirements of the MDD. The Essential Requirements concern health and safety, and that the product performs according to its intended use. There are, slightly simplified, two principally different ways to acquire C-marking for medical devices: 1. Quality assurance system route The MDD, Annex I, Essential Requirements, does not explicitly specify that the manufacturer requires a full certification according to the standards ISO 9001 and/or ISO 13485, but does require that "The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking into account the generally acknowledged state-of-the-art". Compliance with the ISO 13485, possibly together with the ISO 9001, is, however, regarded as the generally accepted way of showing partial compliance with the safety principles of the MDD, providing the technical files (for the products) contain the necessary information for documentation of safety. Compliance with MDD's Annex II (full quality assurance similar to ISO 9001/ISO 13485), together with the previously mentioned provision of the technical files for the individual products, will grant the right to affix the C-marking to any type of medical device. For Class IIa products, there is also the possibility of following the procedure relating to the EC declaration of conformity set out in Annex VII of MDD, coupled with either compliance with Annex V (production quality assurance) or Annex VI (product quality assurance), in addition to the technical files for the individual products. These routes may be combined with certification according to one or both of the standards ISO 9001 and ISO 13485. Such certification may also be granted by Nordic Dental Certification. Note: Certification according to ISO 9001 and/or ISO 13485 does not alone give the right to affix C-marking to medical devices.
2. Product certification route For Class IIa products, this involves testing of samples of the products, in order to perform a conformity assessment according to Annex IV of MDD, combined with Annex VII (EC declaration of conformity). This route may be combined with voluntary product certification according to international product standards .
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Phone: +47 67 581530 |
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Contact information: |
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Notified Body |
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Postal address: P.O. Box 70 |
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Postal address: P.O. Box 70 |