The scope of the Directive covers all instruments, apparatus, appliances, equipment, substances or other articles, whether used alone or in combination, intended by the manufacturer to be used by humans for the following purposes:
he detection, prevention, monitoring, treatment or alleviation of disease the detection, monitoring, treatment, mitigation or compensation of injury or disability; examination, replacement or modification of the anatomical structure or a physiological process;
and whose principal intended action in or on the human body is not obtained by pharmacological, immunological or metabolic means, but whose mode of action may be assisted by such means. The software used for the proper functioning of the medical device is also included.
The introduction of the new MDR is a big leap for medical device manufacturing for Europe. With about six months to get their ducks in a row, manufacturers need to have a firm understanding of the new regulations and what processes they need to implement to ensure their products comply. While introducing the new requirements is undoubtedly causing headaches for manufacturers, particularly as there has been very few guidance documents released by the European Commission, the long-term benefits to patient safety make the MDR a welcome development.
In November 2019, the European union has published a second corrigendum for the MDR, in which they have extended certain Class I devices an additional four years to comply to the MDR. This corrigendum proposes to make changes to Article 78(8), Article 84, Article 88(1), Article 120 (3), Article 120(4), Article 120(8), Article 122, Annex I and Annex III 11. However, this corrigendum needs to be adopted by the European parliament to take effect.
Yanimed is a brand of Yanimed LLC based in Delaware US. Under the brand name Yanimed we produce disposable protective gloves for medical and industrial use.
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