Regulatory Open Forum

Dear colleagues,

As per UK new Guidance "Regulating medical devices in the UK" the device must comply with the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002), that came into force on 1st January 2021.

The version of the UK MDR 2002 No.618 provided on the legislation.gov.uk states that there are outstanding changes to be made to the document, so they don't present the latest version of the regulation containing all the applicable amendments.

As per the legislation.gov.uk editorial team, changes from amendments like 2017 No. 207, 2019 No. 791, 2019 No. 1385, 2020 No. 1478 and others, are not yet included on the UK MDR 2002 No 618 text.

Does anyone have access to the latest version of the UK MDR 2002 No 168 containing all the changes done by the amendments? Or can tell where the updated document could be found?

Thanks in advance!

Dear colleagues,

As per UK new Guidance "Regulating medical devices in the UK" the device must comply with the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002), that came into force on 1st January 2021.

The version of the UK MDR 2002 No.618 provided on the legislation.gov.uk states that there are outstanding changes to be made to the document, so they don't present the latest version of the regulation containing all the applicable amendments.

As per the legislation.gov.uk editorial team, changes from amendments like 2017 No. 207, 2019 No. 791, 2019 No. 1385, 2020 No. 1478 and others, are not yet included on the UK MDR 2002 No 618 text.

Does anyone have access to the latest version of the UK MDR 2002 No 168 containing all the changes done by the amendments? Or can tell where the updated document could be found?

Thanks in advance!

Dear colleagues,

As per UK new Guidance "Regulating medical devices in the UK" the device must comply with the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002), that came into force on 1st January 2021.

The version of the UK MDR 2002 No.618 provided on the legislation.gov.uk states that there are outstanding changes to be made to the document, so they don't present the latest version of the regulation containing all the applicable amendments.

As per the legislation.gov.uk editorial team, changes from amendments like 2017 No. 207, 2019 No. 791, 2019 No. 1385, 2020 No. 1478 and others, are not yet included on the UK MDR 2002 No 618 text.

Does anyone have access to the latest version of the UK MDR 2002 No 168 containing all the changes done by the amendments? Or can tell where the updated document could be found?

Thanks in advance!

Either,

• In direct association with each section of the Table of Contents, consequently requiring us to click on each section to manually locate and review the latest iteration of that section.  For example, if one clicks on Regulation 2 (Interpretation) of Part 1, the latest iteration of Regulation 2 Part 1 is displayed in piecemeal fashion as follows: i) the text directly on the screen reflects the changes made to Regulation 2 up through the date shown in the 'Changes over time' timeline displayed when selecting 'Show Timeline of Changes' under 'Advanced Features'. In the case of Regulation 2, that date is 01/09/2007, which is the latest consolidated (yet still outdated) version assembled on legislation.gov.uk site; ii) the pink box allows us to identify and review the changes made specific to Regulation 2 after 01/09/2007; iii) the gold box allows us to identify Brexit-related changes.  In summary, sub-steps i, ii, and iii need to be performed in order to realize the latest version of Regulation 2, Part 1.  This same approach appears to be necessary for each of the sections in the aforesaid Table of Contents.

Or,

• A consolidated list of, and links to, the various historical changes (spanning from 2003 to 2020, yet not necessarily including the Brexit changes) appears to be available as follows: i) From the aforesaid Table of Contents page, click the 'More Resources' drop-down menu on the left column. b) Select 'View more>'. c) Click 'Affecting The Medical Devices Regulations 2002>'. This listing is neat because it identifies which changes have been integrated into the texts that appear directly on the screens (e.g., see step a.i. above), and which changes haven't (thus requiring review of the red and gold boxes).

Dear colleagues,

As per UK new Guidance "Regulating medical devices in the UK" the device must comply with the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002), that came into force on 1st January 2021.

The version of the UK MDR 2002 No.618 provided on the legislation.gov.uk states that there are outstanding changes to be made to the document, so they don't present the latest version of the regulation containing all the applicable amendments.

As per the legislation.gov.uk editorial team, changes from amendments like 2017 No. 207, 2019 No. 791, 2019 No. 1385, 2020 No. 1478 and others, are not yet included on the UK MDR 2002 No 618 text.

Does anyone have access to the latest version of the UK MDR 2002 No 168 containing all the changes done by the amendments? Or can tell where the updated document could be found?

Thanks in advance!

Either,

• In direct association with each section of the Table of Contents, consequently requiring us to click on each section to manually locate and review the latest iteration of that section.  For example, if one clicks on Regulation 2 (Interpretation) of Part 1, the latest iteration of Regulation 2 Part 1 is displayed in piecemeal fashion as follows: i) the text directly on the screen reflects the changes made to Regulation 2 up through the date shown in the 'Changes over time' timeline displayed when selecting 'Show Timeline of Changes' under 'Advanced Features'. In the case of Regulation 2, that date is 01/09/2007, which is the latest consolidated (yet still outdated) version assembled on legislation.gov.uk site; ii) the pink box allows us to identify and review the changes made specific to Regulation 2 after 01/09/2007; iii) the gold box allows us to identify Brexit-related changes.  In summary, sub-steps i, ii, and iii need to be performed in order to realize the latest version of Regulation 2, Part 1.  This same approach appears to be necessary for each of the sections in the aforesaid Table of Contents.

Or,

• A consolidated list of, and links to, the various historical changes (spanning from 2003 to 2020, yet not necessarily including the Brexit changes) appears to be available as follows: i) From the aforesaid Table of Contents page, click the 'More Resources' drop-down menu on the left column. b) Select 'View more>'. c) Click 'Affecting The Medical Devices Regulations 2002>'. This listing is neat because it identifies which changes have been integrated into the texts that appear directly on the screens (e.g., see step a.i. above), and which changes haven't (thus requiring review of the red and gold boxes).

Dear colleagues,

As per UK new Guidance "Regulating medical devices in the UK" the device must comply with the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002), that came into force on 1st January 2021.

The version of the UK MDR 2002 No.618 provided on the legislation.gov.uk states that there are outstanding changes to be made to the document, so they don't present the latest version of the regulation containing all the applicable amendments.

As per the legislation.gov.uk editorial team, changes from amendments like 2017 No. 207, 2019 No. 791, 2019 No. 1385, 2020 No. 1478 and others, are not yet included on the UK MDR 2002 No 618 text.

Does anyone have access to the latest version of the UK MDR 2002 No 168 containing all the changes done by the amendments? Or can tell where the updated document could be found?

Thanks in advance!