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What legislation is relevant to medical device regulation in Europe EU 2017/745

2026-07-22
97 Author:Xuntong Standard
Article Keywords:

Medical Device Regulation EU 2017/745
  
After a four-year transition period, it will apply from May 26, 2021. This regulation repeals Directive 93/42/EEC on medical devices and Directive 90/385/EEC on active implantable devices.

EU 2017/745

In vitro diagnostic equipment regulation EU 2017/746
  
After a five-year transition period, implementation will begin on May 26, 2022. At the same time, manufacturers can choose to place in vitro diagnostic devices on the market in accordance with Directive 98/79/EC or new regulations, provided they fully comply with the Directive.
  
Medical Products Containing Medical Devices (Combination Products) Directive 2001/83/EC
  
Some drugs are used in conjunction with medical equipment, often to be able to deliver the drug. If the main intended effect of a combination product is achieved by a drug, the entire product will be regulated as a pharmaceutical product in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004.