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Alison Dennis

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Justyna Ostrowska

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作者

Alison Dennis

合伙人

Read More

Justyna Ostrowska

律师

Read More

2021年5月27日

Attention UK medical devices companies! The new enforcement rules for medical devices are (almost) here

  • Quick read

Many of the new enforcement rules under the Medicines and Medical Devices Act 2021 (MMDA) came into force on 26 May 2021, with the enactment of The Medicines and Medical Devices Act 2021 (Commencement No. 1 and Transitional and Savings Provision) Regulations 2021.

From 26 May 2021, the MHRA has new enforcement tools at its disposal. Here's a quick round-up of the key changes. 

Directors and officers beware

Under the MMDA, company officers are liable for a criminal offence of their own if the corporate offence was committed with their "consent or connivance", or even if the offence is attributable to neglect on their part.

Medical device company directors should take this seriously because negligence does not require deliberate conduct, merely a lack of reasonable care – an unusual basis under English law for imposing criminal responsibility. 

Companies will want to ensure that there are clear lines of responsibility firmly embedding a compliance culture from the top down and that procedures are supported with internal audits and regular training.

New due diligence defence

The MMDA introduces a new due diligence defence to the important corporate criminal offence of breaching of any of the notices served by the MHRA. To successfully use this defence, companies and individuals will need to show that they took "all reasonable steps and exercised all due diligence to avoid commission of the offence."

It's vital that medical device companies map out what steps, policies, training and procedures they need to have in place to ensure that their medical devices will remain compliant with the law. Solid processes and procedures which are actively managed will help to support the company and its officers should they ever need to deploy the defence that they took "all reasonable steps" to ensure compliance. 

Additional costs

The MMDA provides opportunities for the regulator to charge medical device companies. For example, the MHRA may seek a court order for reimbursement of its enforcement costs against a company with a forfeiture order made against them, or if the company has been convicted of breaching one of the four notices the MHRA is now entitled to issue for breaches of the applicable law. 

As non-compliance is about to become more expensive, we advise medical device companies to bolster their regulatory teams. This will allow them to provide enough coverage to maintain compliance with medical device laws.

More changes to come

The biggest changes in the UK enforcement regime, such as monetary penalties and enforcement undertakings, are yet to come into force. The next step for companies selling devices in the UK is to identify the action steps both to ensure compliance with the law and to establish a defence of due diligence.

If you would like to discuss these next steps in greater detail, please contact a member of our Life Sciences & Healthcare team. 

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