Regulatory Open Forum

The EU maintains a list of recently published documents a https://ec.europa.eu/docsroom/documents

 The list recently moved to this website and appears to include only documents published in 2019; the documents may have dated in a prior year.

 There are a number of documents on the list because that are related to EU-MDR implementation. Go to the website and review the list. The entry has a link that takes you a page that allows you to download the document.

The documents I noticed are:

List of national market surveillance authorities by sector

MDCG 2019-2 Guidance on application of UDI rules to device-part of products referred to in Article 1(8), 1(9) and 1(10) of Regulation 745/2017

MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES

Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) – infographics

Transition Timelines from the Directives to the Regulations - Medical Devices and in vitro Diagnostic Medical Devices

MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI

Factsheet for the Procurement Ecosystem of Medical Devices and in vitro Diagnostic Medical Devices

MDR and IVDR implementing measures rolling plan

Factsheet for Manufacturers of Medical Devices - AR, JP, RU

Factsheet for Manufacturers of Medical Devices

Implementation Model for Medical Devices Regulation - Step by Step Guide

Factsheet for Manufacturers of in vitro Diagnostic Medical Devices

Implementation Model for in vitro Diagnostic Medical Devices Regulation - Step by Step Guide

MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES

state-of-play of joint assessments of Notified Bodies in the medical device sector

MDCG 2018-1 Draft guidance on basic UDI-DI and changes to UDI-DI

The EU maintains a list of recently published documents a https://ec.europa.eu/docsroom/documents

 The list recently moved to this website and appears to include only documents published in 2019; the documents may have dated in a prior year.

 There are a number of documents on the list because that are related to EU-MDR implementation. Go to the website and review the list. The entry has a link that takes you a page that allows you to download the document.

The documents I noticed are:

List of national market surveillance authorities by sector

MDCG 2019-2 Guidance on application of UDI rules to device-part of products referred to in Article 1(8), 1(9) and 1(10) of Regulation 745/2017

MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES

Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) – infographics

Transition Timelines from the Directives to the Regulations - Medical Devices and in vitro Diagnostic Medical Devices

MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI

Factsheet for the Procurement Ecosystem of Medical Devices and in vitro Diagnostic Medical Devices

MDR and IVDR implementing measures rolling plan

Factsheet for Manufacturers of Medical Devices - AR, JP, RU

Factsheet for Manufacturers of Medical Devices

Implementation Model for Medical Devices Regulation - Step by Step Guide

Factsheet for Manufacturers of in vitro Diagnostic Medical Devices

Implementation Model for in vitro Diagnostic Medical Devices Regulation - Step by Step Guide

MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES

state-of-play of joint assessments of Notified Bodies in the medical device sector

MDCG 2018-1 Draft guidance on basic UDI-DI and changes to UDI-DI

The EU maintains a list of recently published documents a https://ec.europa.eu/docsroom/documents

 The list recently moved to this website and appears to include only documents published in 2019; the documents may have dated in a prior year.

 There are a number of documents on the list because that are related to EU-MDR implementation. Go to the website and review the list. The entry has a link that takes you a page that allows you to download the document.

The documents I noticed are:

List of national market surveillance authorities by sector

MDCG 2019-2 Guidance on application of UDI rules to device-part of products referred to in Article 1(8), 1(9) and 1(10) of Regulation 745/2017

MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES

Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) – infographics

Transition Timelines from the Directives to the Regulations - Medical Devices and in vitro Diagnostic Medical Devices

MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI

Factsheet for the Procurement Ecosystem of Medical Devices and in vitro Diagnostic Medical Devices

MDR and IVDR implementing measures rolling plan

Factsheet for Manufacturers of Medical Devices - AR, JP, RU

Factsheet for Manufacturers of Medical Devices

Implementation Model for Medical Devices Regulation - Step by Step Guide

Factsheet for Manufacturers of in vitro Diagnostic Medical Devices

Implementation Model for in vitro Diagnostic Medical Devices Regulation - Step by Step Guide

MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES

state-of-play of joint assessments of Notified Bodies in the medical device sector

MDCG 2018-1 Draft guidance on basic UDI-DI and changes to UDI-DI

The EU maintains a list of recently published documents a https://ec.europa.eu/docsroom/documents

 The list recently moved to this website and appears to include only documents published in 2019; the documents may have dated in a prior year.

 There are a number of documents on the list because that are related to EU-MDR implementation. Go to the website and review the list. The entry has a link that takes you a page that allows you to download the document.

The documents I noticed are:

List of national market surveillance authorities by sector

MDCG 2019-2 Guidance on application of UDI rules to device-part of products referred to in Article 1(8), 1(9) and 1(10) of Regulation 745/2017

MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES

Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) – infographics

Transition Timelines from the Directives to the Regulations - Medical Devices and in vitro Diagnostic Medical Devices

MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI

Factsheet for the Procurement Ecosystem of Medical Devices and in vitro Diagnostic Medical Devices

MDR and IVDR implementing measures rolling plan

Factsheet for Manufacturers of Medical Devices - AR, JP, RU

Factsheet for Manufacturers of Medical Devices

Implementation Model for Medical Devices Regulation - Step by Step Guide

Factsheet for Manufacturers of in vitro Diagnostic Medical Devices

Implementation Model for in vitro Diagnostic Medical Devices Regulation - Step by Step Guide

MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES

state-of-play of joint assessments of Notified Bodies in the medical device sector

MDCG 2018-1 Draft guidance on basic UDI-DI and changes to UDI-DI

The EU maintains a list of recently published documents a https://ec.europa.eu/docsroom/documents

 The list recently moved to this website and appears to include only documents published in 2019; the documents may have dated in a prior year.

 There are a number of documents on the list because that are related to EU-MDR implementation. Go to the website and review the list. The entry has a link that takes you a page that allows you to download the document.

The documents I noticed are:

List of national market surveillance authorities by sector

MDCG 2019-2 Guidance on application of UDI rules to device-part of products referred to in Article 1(8), 1(9) and 1(10) of Regulation 745/2017

MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES

Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) – infographics

Transition Timelines from the Directives to the Regulations - Medical Devices and in vitro Diagnostic Medical Devices

MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI

Factsheet for the Procurement Ecosystem of Medical Devices and in vitro Diagnostic Medical Devices

MDR and IVDR implementing measures rolling plan

Factsheet for Manufacturers of Medical Devices - AR, JP, RU

Factsheet for Manufacturers of Medical Devices

Implementation Model for Medical Devices Regulation - Step by Step Guide

Factsheet for Manufacturers of in vitro Diagnostic Medical Devices

Implementation Model for in vitro Diagnostic Medical Devices Regulation - Step by Step Guide

MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES

state-of-play of joint assessments of Notified Bodies in the medical device sector

MDCG 2018-1 Draft guidance on basic UDI-DI and changes to UDI-DI

The EU maintains a list of recently published documents a https://ec.europa.eu/docsroom/documents

 The list recently moved to this website and appears to include only documents published in 2019; the documents may have dated in a prior year.

 There are a number of documents on the list because that are related to EU-MDR implementation. Go to the website and review the list. The entry has a link that takes you a page that allows you to download the document.

The documents I noticed are:

List of national market surveillance authorities by sector

MDCG 2019-2 Guidance on application of UDI rules to device-part of products referred to in Article 1(8), 1(9) and 1(10) of Regulation 745/2017

MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES

Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) – infographics

Transition Timelines from the Directives to the Regulations - Medical Devices and in vitro Diagnostic Medical Devices

MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI

Factsheet for the Procurement Ecosystem of Medical Devices and in vitro Diagnostic Medical Devices

MDR and IVDR implementing measures rolling plan

Factsheet for Manufacturers of Medical Devices - AR, JP, RU

Factsheet for Manufacturers of Medical Devices

Implementation Model for Medical Devices Regulation - Step by Step Guide

Factsheet for Manufacturers of in vitro Diagnostic Medical Devices

Implementation Model for in vitro Diagnostic Medical Devices Regulation - Step by Step Guide

MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES

state-of-play of joint assessments of Notified Bodies in the medical device sector

MDCG 2018-1 Draft guidance on basic UDI-DI and changes to UDI-DI