Please see below for an MDR update from Mark Cutler:
Medical Device Regulations, May 2021
Updated Information- IMPT Membership 05/2021
Introduction
Following the Queens’ Speech in Parliament on Tuesday 11 May 2021, the “Medicines and Medical Devices Act” has received Royal ascent and is now entered into UK law.
This latest piece of UK legislation has been created, following BREXIT, to support new powers and provide a stand-alone legal framework for the development of a UK wide regulatory system covering the manufacture and use of medical devices. As outlined in section four of the new bill, an obvious task of this legislation was to merge enforcement provisions for medical devices within the UK.
Prior to the Medicines and Medical Devices Act, enforcement provisions were disseminated across other pieces of UK legislation such as the Consumer Protection Act (1987), Consumer Rights Act (2015), Trades Descriptions Act 1968, Medical Device Regulations (2002) and General Product Safety Regulations (2005). This created a blurred legal environment for manufacturers, prescribers, users and patients; especially if things went wrong and a civil action/case arose. The new Act removes medical devices from the sphere of consumer protection law and creates a distinct framework of criminal and civil sanctions specifically for the medical devices sector.
The Medicines and Medical Devices Act introduces into UK law a specific offence for contravention of Medical Device Regulations 2002. This includes any failure by a manufacturer to follow official notice(s) set out by a governmental/competent authority (i.e. MHRA). Also mentioned within the bill are details of financial and penal sanctions, including a 51 week term of imprisonment, and the availability of a ‘due diligence’ defence position, should a person be accused of an offence relating to the manufacture of a medical device.
The new bill defines a system of civil sanctions as an alternative to (expensive and resource heavy) criminal prosecution. With this facility; as outlined in detail within schedule 2 of the bill; financial penalties can now be imposed by UK Government where it has been proven that a criminal offence has been committed. With regard to an organisation or commercial company being at fault, the bill appears to use vocabulary similar to that applied in the utility energy and aviation industries, including such terms as “attributable negligence” and “connivance and consent”. To this end, this new Act also provides a facility for punitive action to be taken against individuals in senior positions within large organisations.
Outcome & comment
This new piece of legislation lacks any detail that we, as manufacturers of cranio-maxillofacial devices, can apply in our day-to-day practise. However, following the post-BREXIT manoeuvrings of HM Government, and the side-lining of EU Regulation 2017/745 at the end of last year, this new bill was necessary to give the MHRA ‘teeth’ and allow the enforcement medical device regulations in the UK’s post-BREXIT future.
It would be inappropriate to second guess the form of any further regulatory guidance that will ultimately update and supersede current legislation. In addition, we are currently unaware of any additional legal powers that will now be imparted by UK government to the MHRA. We should also note with caution the mitigating concept of ‘due diligence’: this apparently helpful clause clearly indicates that, by failing to show due diligence, liability will immediately be brought into question.
Going forwards
IMPT Council will consider all further medical device specific regulatory information; as it is announced by UK government, and any guidance notes published by MHRA; to update and inform IMPT membership.
