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How Will UK’s MMD and EU’s MDR Affect the Medtech Industry?

2021/6/10 18:07:30 Views:415


Original from mddionline

Author: Sabrina Par


The United Kingdom’s exit from the European Union, or Brexit, has brought about changes to the global market. In particular, the UK’s Medicines and Medical Devices Act 2021 (MMD) and the EU’s Medical Device Regulation (MDR) will impact the trade and use of medical devices to and from the UK and the EU, respectively. Since the EU parliament ratified Brexit on April 27, 2021, all UK regulations, including the MMD, are starting to affect companies worldwide.

 

We’ll take a look at how UK’s MMD and EU’s MDR will affect the medtech industry in the region and worldwide, particularly at how medical interpreters may be affected by this regulation. Medical translators and interpreters are charged with translating instruction manuals, regulatory compliance documents, vaccine informational packets and packages, and manufacturing process descriptions. These translators will also help ensure regulatory compliance with the EU and UK laws as well as issue certifications as needed. Medical device manufacturers also work with translators for product labels, instruction packets, and other necessary information.

 

Medical interpreters who work in inpatient or outpatient services may also work alongside medical device manufacturers. These healthcare interpreters could relay information from manufacturers to facilities to doctors to patients. They could make the road easier, from teaching patients how to use devices to facilitating how manufacturers communicate with facilities.

 

The UK’s Medicines and Medical Devices Act 2021 (MMD)—A Catalyst for Change

 

As part of a post-Brexit resolution, the UK has finalized and implemented the MMD Act, or the Medicines and Medical Devices Act 2021. The MMD Act gives the Secretary of State for Health immense powers for medical devices in the UK. It also establishes the position of a Commissioner for Patient Safety.

 

The varied reasons for proposing the legislation include allowing the UK to depart from existing EU rules to regulate these products, easily amending existing laws for medical devices, and ensuring patient safety along with medtech innovation.

 

In its latest iteration as of March 2021, the Act provides increased measures for the UK Medicines and Healthcare Products Regulatory Agency (MHRA), which will be responsible for providing reports to Parliament.

 

Here are a few things about the MHRA:

 

The MHRA is the governing body of all medical devices in England, Scotland, and Wales, responsible for licensing and regulating medical devices.

The MHRA has the power to impose criminal sanctions against all individuals, corporations, and other offenders of the MDR Act.

As of now, the UK is still in the transition period, as mentioned before. The official break of the UK from the EU was ratified on April 27 thanks to a vote in the EU Parliament. Brexit will impact almost all segments of the UK economy, when all rights and reciprocal arrangements end. The vote marks the end of the transition period and new rules apply, such as the MHRA.

 

EU’s Medical Devices Regulation (MDR)

 

To make things even more complicated, the EU’s MDR, or Medical Device Regulation, will be in place, however, for EU countries.

 

According to studies by Globaldata, more than 20,000 medical devices have been delayed, with almost half in the early stages of development.

 

The most important part of the EU’s MDR requires medtech companies to update their IT systems and submit the required documentation for the database and to reassess clinical trials for certain products.

 

How Could These Rules Affect the MedTech Industry in the Future?

 

Here are a few potential impacts:

 

1.     There will likely be a disruption of the medical device supply exported and imported to and from the UK and the EU, since businesses will struggle to meet the demands for both countries at the same time.

2.     Both the MDR and the MMD will also affect the pipeline of products since they will be placed on a high-volume list of device approvals.

3.     Because of #2, there might be a decline in the volume of approved devices, which means medtech companies may experience business-wide losses when it comes to the European market.

4.     For the EU’s MDR, medtech companies will have to update their IT systems and submit the required documentation for the database.

5.     The new rules will affect existing devices de facto, since MDR and MMD prioritize safety, resulting in an impact on hospital purchases and purchasing decisions.

 

What’s the Impact on MedTech Companies, Hospital Administrators, Medical Interpreters, and Medical Practitioners?

 

With the projected delay and decline of medical devices imported to the European market, the worldwide medtech industry could be affected. Such effects could be felt by manufacturers and medtech companies as well as by hospitals, doctors, nurses, and medical staff.

 

Medical interpreters who transpose vital information could be hit hard as well since medical interpreters are part of clinical trials, especially in conveying information from the UK or the EU to medtech companies and then hospitals. This will lead to increased paperwork and a huge translation workload to follow this review process. With the EU leading the clinical investigations, there might be a surge in trained medical interpreters to specifically handle these various types of work. Medical interpreting, as a highly vital medical field, may prove responsible for communication within and outside of hospitals.