Special authorizations are a concept of the MDR (Article 59). In this way, the legislator wants to create a possibility to place medical devices on the market in emergency or exceptional cases, even without having gone through a complete or successful conformity assessment procedure. Special authorizations should not be confused with concessions and exemptions under…
DetailsBoth the MDR and IVDR introduce the concept of Common Specifications. Definition of Common Specifications MDR and IVDR define Common Specifications as follows: Purpose of Common Specifications EU Directives, such as the MDD and IVDD, as well as EU Regulations, such as the MDR and IVDR impose so-called general requirements on all medical devices must meet. If the requirements are not met, manufacturers must not…
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