Medical Device Legislation Extended 12 MonthsMedical Devices
To reduce the chances of medication supply delays, and to guarantee the new regulatory system is primed for release, regulation bodies are “introducing a 12-month extension to the implementation of the future Medical Device Regulations, with an aim to bring the new regulations into force by July 2024”
If a manufacturers’ product has the "CE" designation, it attests to their conformity with EU medical device standards. This means they will be permitted to keep these products on British market up to the point of June 30th, 2024, not June 30th, 2023 as the UK administration had formerly said.
“The government stated in its release from June that the most recent laws should go into effect next year. Intermediate measures will start to take effect on July 1, 2024.“
It was officially published almost 5 months ago that the updated medical device governing system will be based on five main points. Achieving globally exemplary standards, notably by creating the UK CE mark equivalent- the UKCA mark, will be included in this.
The government stated in its release from June that the most recent laws should go into effect next year. Intermediate measures will start to take effect on July 1, 2024.
Louise Fullwood, life sciences proficient and solicitor at Pinsent Masons explained that “Combined with the Retained EU Laws Bill, it's a continuously moving platform for the medical devices industry. This further delay takes away the impetus for manufacturers to get UKCA-ready with no certainty on what the eventual position will be.”
There is a “relatively small number of UK approved bodies for carrying out conformity assessments – Dekra was appointed last month as just the third UK approved body. A further six organisations are currently going through the approval process and the MHRA is in discussions with several other potential candidates.”
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