Blog

16Sep

Update on Medicines and Medical Devices Bill

The Medicines and Medical Devices Bill is continuing to progress through the House of Lords. After its second reading in the House of Lords on the 2nd September, the legislation is now passing through a Committee stage. Further amendments to the Bill have now been published from this stage as a prelude to their review by a House of Lords Grand Committee. The Committee stage in the House of Lords involves detailed line by line examination of the separate parts (clauses and schedules) of a Bill. Starting from the front of the bill, members work through to the end. Any member of the Lords can take part. Usually starting about two weeks after the second reading debate, committee stage generally lasts for up to eight days, but can go on for longer.

Specifically, the amendments proposed include several by Lord Sharkey which would replace particular existing affirmative procedures with a super-affirmative procedure to increase parliamentary scrutiny. Lord Freyberg and Lord Clement-Jones are seeking to put forward an amendment also. This would see an improved approach by the Bill on addressing new technologies which have significant potential for harm. Such a legislative move would bring the Bill closer to aligning with and improving on the EU and US equivalents. Both aforementioned Lords also tabled an amendment which updates the definition of ‘medical device’ to bring it in line with the EU and US regulation. This will assist in acknowledging the progress of technology beyond the Medical Devices Regulations 2002.

A date for the Grand Committee has not yet been published, BIVDA will continue to monitor the Bill’s progression through Parliament.

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