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MDCG 2021- 10 – The status of appendixes E-I of IMDRF N48 under the EU regulatory framework for medical device – May 2021

9 Jul 2021 | All the News, MDCG

Theme UDI Target Audience Manufacturer Products concerned MD and IVD Documents mentioned MDR (EU) 2017/745 Annex VI IVDR (EU) 2017/746 IMDRF/UDI WG/N48 FINAL: 2019 MDCG 2019-11 This document is intended to provide interpretations on how certain principles and...

MDCG 2021-09 : Position paper on the implementation of UDI requirements for contact lenses, spectacle frames, spectacles lenses & ready readers – May 2021

9 Jul 2021 | MDCG

Theme UDI Target Audience Manufacturer Products concerned MD (contact lenses, spectacles frames, spectacles lenses and ready readers) Documents mentioned MDR (EU) 2017/745 Chapter III Annex VI MDCG 2020-18 This position paper is intended to provide further...

The regulatory minute – Choose the conformity assessment procedure for your MD: no stress!

27 Oct 2020 | Regulation

The conformity assessment procedure is the regulatory path that allows the manufacturer (or the notified body if applicable) to assess the conformity of a device before it is placed on the market. There are several possible path, depending on the class of the device....

The regulatory minute: UDI & EUDAMED, what are your obligations?

16 Oct 2020 | All the News, Regulation

UDI and EUDAMED are two KEY new features of the MDR. But practically speaking, as a manufacturer, what will you actually be required to do? Let’s recap! 1) To get started, you will need to assign a UDI to the device and all higher levels of packaging and assign...

GDPR compliance and transfer of data to third countries: the CJEU rules

24 Jul 2020 | Regulation

In a major ruling on July 16 (see press release), the Court of Justice has provided us with guidance on what it considers to be “an adequate level of protection” for personal data transferred to a third country under the GDPR. It ruled on the inadequacy of...

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MDCG 2021- 10 – The status of appendixes E-I of IMDRF N48 under the EU regulatory framework for medical device – May 2021

MDCG 2021-09 : Position paper on the implementation of UDI requirements for contact lenses, spectacle frames, spectacles lenses & ready readers – May 2021

The regulatory minute – Choose the conformity assessment procedure for your MD: no stress!

The regulatory minute: UDI & EUDAMED, what are your obligations?

GDPR compliance and transfer of data to third countries: the CJEU rules

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MDCG 2021- 10 – The status of appendixes E-I of IMDRF N48 under the EU regulatory framework for medical device – May 2021

MDCG 2021-09 : Position paper on the implementation of UDI requirements for contact lenses, spectacle frames, spectacles lenses & ready readers – May 2021

The regulatory minute – Choose the conformity assessment procedure for your MD: no stress!

The regulatory minute: UDI & EUDAMED, what are your obligations?

GDPR compliance and transfer of data to third countries: the CJEU rules

Search in the Website

All the topics

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