To improve MDlaw experience, and keep you informed of all the relevant documents of the previous month that have been collected in our Library of Documents, we will be preparing such a notice on a monthly basis – available in our News section.
EUROPEAN COMMISSION
- Getting ready for the new regulations (EC)
👉 Manufacturers MD (EC)
👉 Manufacturers of devices without an intended medical purpose (EC)
👉 Manufacturer IVD (EC)
👉 Authorised Representatives, Importers, Distributors (EC)
👉 Healthcare professionals and health institutions (EC)
👉 Competent authorities in non-EU/EEA countries (EC)
👉 The procurement of MDs and IVDs (EC)
- Experts panels – list established by the EC
NOTIFIED BODY
- 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
- 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)
STANDARDS:
PUBLIC CONSULTATIONS:
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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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