Medical Devices Regulation (EU)

The new EU Medical Devices Regulation 2017/745 (MDR) applies from (yesterday) 26 May, after a year’s postponement. The MDR is here.

The MDR tightens controls on high-risk devices such as implants and requires the consultation of a pool of EU level experts before placing medical devices on the market. Clinical evaluations, investigations and the notified bodies that approve the certification of medical devices will be subject to tighter controls.

The new European database of medical devices (EUDAMED) will contain information about each medical device on the market, including economic operators and certificates issued by notified bodies. Each device will have a unique device identifier so that it can be found in EUDAMED. Labelling will be more detailed and electronic manuals will increase user-friendliness. Implant patients will receive an implant card with all the essential information.

Once devices are available on the market, manufacturers will have to collect data about the devices’ performance. EU countries will closely coordinate their vigilance and market surveillance.

The MDR is complemented by the Regulation on in vitro diagnostic medical devices (2017/746/EU) which applies a year later on 26 May 2022.

Q&A about the MDR is here.

Medicines and Medical Devices Bill (UK Brexit)

The (Brexit) Medicines and Medical Devices Bill 2019-20 was announced in the Queen’s Speech on 19 December 2019. The second reading is taking place today.

A large proportion of the legal framework for medicines and medical devices in the UK derives from EU Directives and has been implemented into domestic legislation through section 2(2) of the European Communities Act 1972 (ECA). This enables EU Directives to be transposed into UK law through secondary legislation and has been used to create a body of regulations that include the:

• Human Medicines Regulations 2012

• Medicines for Human Use (Clinical Trials) Regulations 2004

• Veterinary Medicines Regulations 2013

• Medical Devices Regulations 2002.

At the end of the Transition Period, the European Union (Withdrawal) Act 2018 (see the Brexit Law List in subscribers’ systems) will have preserved these frameworks as “retained EU Law”. Since the ECA is now no longer available (due to the Act that implemented the Withdrawal Agreement), there is no other ‘general power’ for updating these regulations from 1st January 2021, except through the introduction of new primary legislation.

The Medicines and Medical Devices Bill seeks to address this regulatory gap through introducing regulation-making, delegated powers covering the fields of

* human medicines,

* clinical trials of human medicines,

* veterinary medicines, and

* medical devices.

Its purpose is to enable the existing regulatory frameworks to be updated at the end of the Transition Period.

The Bill has been drawn to create ‘targeted’ delegated powers which can only be exercised in relation to a restricted number of matters. The Government states in the Explanatory Notes to the Bill that it intends to use these powers to keep the existing regulatory frameworks updated, while also consolidating the enforcement regime for medical devices. In addition, the Bill will provide the Secretary of State with the ability to impose civil sanctions – as an alternative to criminal prosecution – for breaches of the medical device regime.

Further details are set out in this Commons Briefing – here.

Medicines and MHRA Instructions (UK Brexit)

Exit day is 31st October.

The MHRA today updated its instructions for the regulation of medicines, medical devices and clinical trials after Exit.

Here.

Please see the link on this page to other MHRA instructions issued,

Please check for situations where this comes within the scope of the Brexit Law being consolidated by Cardinal into base law and supplied to subscribers to Cardinal Environment EHS Legislation Registers & Checklists.