Overview of published documents – January 2021

To improve MDlaw experience, and keep you informed of all the relevant documents of the previous month that have been collected in our LibraryΒ  of Documents, we will be preparing such a notice on a monthly basis – available in our News section.


  • Getting ready for the new regulations (EC)

πŸ‘‰ Manufacturers MD (EC)
πŸ‘‰ Manufacturers of devices without an intended medical purpose (EC)
πŸ‘‰ Manufacturer IVD (EC)
πŸ‘‰ Authorised Representatives, Importers, Distributors (EC)
πŸ‘‰ Healthcare professionals and health institutions (EC)
πŸ‘‰ Competent authorities in non-EU/EEA countries (EC)
πŸ‘‰ The procurement of MDs and IVDs (EC)

  • Experts panels – list established by the EC



  • Commission Notice on the application of Sections 2.3 and 3.3 of Annex IX to Regulation (EU) 2017/745 and Regulation (EU) 2017/746 with regard to notified bodies’ audits performed in the context of quality management system assessment (EC)



  • UK approved bodies for medical devices (MHRA)
  • Designated standards: medical devices (MHRA) & Designated standards: active implantable medical devices (MHRA)
  • Guidance: DEHP phthalates in medical devices (MHRA)
  • Guidance for retailers: supplying medical devices to Northern Ireland (MHRA)
  • Guidance: Register as a manufacturer to sell medical devices from 1 January 2021 (MHRA)
  • Guidance: Regulating medical devices from 1 January 2021 (MHRA)





Such an overview is available to all MDlaw members via the Monthly Newsletter. Please contact us at mdlaw@obelis.net in case you do not receive it in your mailbox, every end of the month.

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