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Will tighter regulation of medical devices hamper health innovation?

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David Edwards, head of Harrison Drury’s healthcare and regulatory teams, explores how a recent investigation into unsafe medical devices may affect the healthcare sector and patients.

The UK’s Royal College of Surgeons has called for ‘drastic regulatory changes’ following a recent investigation that highlights that unsafe and inadequately tested medical devices have been used in the treatment of patients.

Although the numbers of patients affected in the UK was not disclosed in the investigation, it states that faulty and inadequate devices have led to more than 1.7m injuries and approximately 83,000 deaths over a 10-year period.

The recent investigation uncovered that, in the absence of adequate regulation, devices which had failed in primates or were only tested on pigs and dead bodies, have been used by medical practitioners. This poses both a risk to patient safety and to public confidence.

A new regulatory framework, coming into force in Europe 2020, will address these inadequacies and aims to prevent unsafe medical devices being released into the European market.

What medical devices are included?

The new regulation will cover devices including:

  • Heart pacemakers
  • Birth control implants
  • Spinal rods
  • Mesh implants for incontinence
  • Implantable defibrillators
  • Artificial knees and hips

Why are new rules being imposed?

Europe does not currently have a centralised authority to properly check medical devices before they are released to the market.

Instead, authorised bodies must issue CE marks to demonstrate that the devices conform to directive requirements. Specifically, the CE mark is designed to demonstrate that the device is fit for its intended purpose and is, above all, safe.

Given that a CE mark may be issued by any one of the 58 bodies in Europe, the current decentralised regulatory system allows companies to ‘shop around’ for approval and leads to discrepancies of opinion as to what is ‘safe’ and what is not.

For example, the Nanostim heart pacemaker was approved by the British Standards Institute in the UK but was rejected by German regulators, due to a lack of supporting medical evidence.

What are some of the issues in tightening the rules and centralising the system?

The extent to which this regulation will help or hinder the healthcare sector is currently unclear.

Patients have the right to be sure in the knowledge that they receive the best treatment using the safest medical devices available. However, access to innovative, efficient and more economic treatments is critical for patients and hospitals in the UK and the rest of Europe.

While the new regulation appears to make a move towards a more centralised approval process, the healthcare sector has asked that it does not unnecessarily alter the current system or reduce the presence of small and medium-sized enterprises in the development of medical devices.

Many of these smaller enterprises are developing innovative medical technologies that not only improve the lives of patients, but also contribute to making the healthcare system more efficient.

The healthcare sector is also concerned that new regulation will delay medical devices reaching patients.

Despite achieving the most important objective of improving safety, a new system will need to ensure it doesn’t prevent access to, or cause unnecessary delays, in the development and delivery of innovative medical technologies.

With the current system, medical devices that help to save lives are available to Europeans three to five years earlier than Americans who have a centralised approval system.

We will therefore need to wait and see what the 2020 regime will mean for future medical development and patient safety.

If you would like to discuss a healthcare regulatory matter with a member of our healthcare team, please contact David on 01772 258321.


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