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MDCG 2021-11 : Guidance on implant card ‘Device types’ – May 2021 – V1.1

9 Jul 2021 | MDCG

Theme Implant card Target Audience Manufacturers Products concerned Implantable Medical Device Documents mentioned MDR (EU) 2017/746 Article 18 MDCG 2019-8 This document provides a non-exhaustive list of implantable medical “device types” to assist...

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...

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MDCG 2021-11 : Guidance on implant card ‘Device types’ – May 2021 – V1.1

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?

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MDCG 2021-11 : Guidance on implant card ‘Device types’ – May 2021 – V1.1

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?

Search in the Website

All the topics

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Archives

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