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NEW | Regulation (EU) 2023/607 entries into force

March 20, 2023

Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices is applicable as of today, 20 March, 2023.

You can find the official document in the following link:

Regulation (EU) 2023/607

The main points to take into consideration are:

  • MDs: if products and manufacturers fulfill certain conditions, the validity of their MDD certificate will be extended.
  • IVDs: products according to IVDD may be made further available on the market and put into service without a legal time restriction.

Should you have any further questions, you can contact us at: info@asphalion.com

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