Time runs out for certifying medical kit

EU medical device regulations

All currently valid Medical Device Directive CE certificates are set to expire this month, marking a critical juncture for EU and UK medical device manufacturers. 

This date holds significant weight, as the EU Commission had anticipated all manufacturers with products on the EU market to transition to the new Medical Device Regulations CE certificate, yet this expectation has not been universally met.

For consultants and GPs, staying informed about these changes to the device regulations is vital to ensure patient safety and compliance, says Tautvydas Karitonas.

Here he explores the recent updates to the regulations and provides practical guidance on what consultants and GPs need to do before the deadline.

What are the Medical Device Regulations (MDR)?

The MDR encompasses a comprehensive set of laws and guidelines governing every stage of a medical device’s life cycle. 

From design and development to testing, manufacturing, labelling, marketing and post-market surveillance, the MDR ensures devices meet stringent safety and efficacy standards.

The regulations have two primary goals: safeguarding the health of patients and users while ensuring the efficient operation of the internal market for medical devices. 

To achieve these aims, and in light of issues identified with the previous regulatory framework, the regulations set out a more robust system of conformity assessment. 

This system ensures the quality, safety and performance of devices available in the EU market.

What is a medical device?

A medical device is a broad category that includes various instruments, apparatus, implants, software and related articles intended for medical purposes. 

Whether it is a simple bandage, blood pressure machine, urine sample container or a more complex surgical instrument, pacemaker or artificial implant, each device plays a crucial role in patient care.

Understanding the MDR 

The Regulation (EU) 2017/745, also known as the MDR, was initiated to create a stronger system for evaluating the conformity of medical devices in the EU market. 

It has been effective since 26 May 2021, superseding the previous medical device directives. The transitional period was set to extend until the 26 May 2024. 

However, due to a lack of capacity among notified bodies and manufacturers’ insufficient readiness to adhere to the MDR’s more rigorous requirements before the transition period ends, the Euro-pean Commission deemed it necessary to prolong this deadline. 

This extension, though, is contingent on certain conditions to ensure only safe devices for which manufacturers have already initiated the transition to the MDR are granted the extra time.

In light of the issues related to Notified Body* capacity, the only options to stay in the market are to hold a valid MDR CE certificate or to obtain an extension to current Medical Device Directive CE certificates. 

This can only be accomplished through an MDR-certification application with a notified body. The situation is reminiscent of a real-world Thanos snap – when the character in the film Avengers: Infinity War  turns half the population of the universe into dust by snapping his fingers – representing a grave risk to our healthcare system, as a considerable number of devices are vulnerable to this risk.

Imagine this: if a manufacturer fails to comply with MDR requirements, their products could be rapidly withdrawn from the market, leading to potential shortages that affect patients who depend on essential devices such as pacemakers or diagnostic tools. 

Additional costs

This impact goes beyond patient care, imposing additional costs on healthcare providers as they struggle to find alternative, potentially pricier devices.

Furthermore, non-compliance damages the reputation of manufacturers and suppliers, undermining trust among healthcare providers, patients and the general public. This erosion of trust can lead to widespread implications, harming businesses and destabilising the healthcare ecosystem.

Considering the UK, which represents 12.1% of all medical devices sold within the UK and EU and is home to the NHS – the largest device consumer – the stakes are exceptionally high. 

The NHS’s struggles with supply chain issues during the Covid-19 pandemic have underscored the critical importance of robust, near-constant monitoring of supply chains to ensure a consistent supply of compliant medical devices. 

The imminent risk of shortages is not hypothetical but a real threat, emphasising the urgent need for pro-active planning and risk mitigation strategies.

This regulatory environment casts a significant shadow over medical device research and development. 

Despite the UK’s medtech sector being one of the fastest-growing globally, the heightened focus on regulation and compliance is diverting resources away from innovation, potentially hindering advancements in critical areas like orthopaedic implants or diagnostic equipment development. 

Increasingly, manufacturers are compelled to prioritise regulatory compliance over pioneering product development, potentially decelerating the rate of progress.

It is pivotal for UK medical device manufacturers and healthcare organisations to ensure they are fully equipped for the MDR deadline. 

Manufacturers must guarantee their devices comply with the stringent requirements set by the regulators, while healthcare organisations should have extensive plans to mitigate both immediate and long-term supply chain disruptions. 

Navigating these regulatory hurdles with flexibility and a dedication to innovation is vital for preserving the health of the UK’s medical device sector and, by extension, the overall healthcare system.

What doctors need to do

Consultants and GPs rely on safe and effective medical devices every day. To safeguard patient safety and ensure accurate diagnosis or treatment, they must utilise devices that have undergone proper CE marking and regulatory scrutiny. 

Understanding market developments and preparing accordingly reinforces this commitment to patient care. Here is what you can do.

1Assess your devices. 

Verify that all your medical devices bear a valid CE mark, ensuring compliance with regulatory standards. 

It is necessary to have all the relevant information from your medical device manufacturers or supplier to ensure you are using fully compliant medical devices. 

Labels should clearly indicate conformity with regulations and standards. Remember, CE marking is not merely a check-box exercise – it is a vital assurance of device safety.

The GMC states that doctors must take the same care when recommending medical devices and digital health tools as they do when issuing traditional prescriptions. 

As with prescribing medication, it is important to ensure that any medical device or digital health tool you recommend is safe, indicated, effective and regulated so that any risks are mitigated.

It is the responsibility of the manufacturer or supplier of the devices to ensure they have regulation approval. However, it is important for GPs and consultants to ensure these checks have been done before recommending or using the devices with patients.

2Collaborate with manufacturers. 

If you own clinics or use supplied devices, engage with manufacturers and ensure they are MDR-ready.

If they are not, it might be that you need to look for other suppliers who are, as any devices that do not meet the MDR could be taken off the market.

3Stay informed.

Regularly monitor updates related to MDR. Attend webinars, workshops and conferences to understand the latest developments.

* A notified body is a conformity assessment body designated in accordance with the applicable legislation, which performs third-party assessment activities to certify products before being placed on the market. 
Notified bodies must operate in a consistent, fair, non-discriminatory, transparent, competent, independent and impartial manner. 
To ensure this, notified bodies competence is assessed by a National Accreditation Body and awarded accreditation against the applicable regulation and harmonised standards such as EN ISO/IEC 17021 Certification of management systems and EN ISO/IEC 17065 Product certification. 

Tautvydas Karitonas is managing director of Test Labs, a medical device testing laboratory for global compliance.