The medical devices landscape has seen major changes in recent years, with the introduction of the Medical Device Regulation in 2017 being the most significant. Triggered by an increasingly complicated system of processes, diversity of technology, and lack of consistent, tangible methods of device traceability and accountability that the previous Directive for Medical Devices (MDD) established in 1993 was lacking, the MDR was introduced to address these issues.  

In a monumentous task for global healthcare, the European Union will introduce the MDR’s latest updates in an effort to further enhance the safety, effectiveness and transparency of medical devices, ensuring better protection for patients and public health. Notably, the MDR aims to standardise medical device regulation across the EU, contributing to unifying a previously disparate industry in terms of regulatory compliance, technology, and approach to safety and performance standards. 

Aside from the primary objective of ensuring high patient protection and strengthening the European internal market for medical devices, the EU also aims to foster innovation and maintain the competitiveness of the medical device industry within the EU. The latest MDR updates seek to accomplish this by implementing more stringent regulatory requirements for medical devices, such as enhanced clinical data testing, tougher standards for manufacturers’ quality management systems, and greater transparency in the supply chain. 

By implementing a unified regulatory framework and introducing systems like the Unique Device Identification (UDI), explored later, the updates will successfully enhance the traceability of medical devices throughout their lifecycle.  

Why was the MDR introduced?  

The MDR came into effect in the European Union in 2021, bringing in more stringent requirements for medical device manufacturers, aiming to address several critical issues found in the previous regulatory framework, the Medical Device Directive (MDD).   

In Ireland, the Health Products Regulatory Authority (HPRA) is responsible for enforcing these regulations. 

Not only has there been a crucial need for an updated regulatory framework that takes into consideration the latest technology and processes permeating the ever-changing healthtech space, but numerous scandals, which have brought forth the attention of patient risk and safety, have prompted the launch, for example: 

• PIP used industrial-grade silicone instead of medical-grade in their breast implants, leading to high rupture rates and health complications.  

• Metal-on-metal hip implants were found to cause severe tissue damage due to metal debris, resulting in numerous revision surgeries.  

• Smiths Medical recalled nearly 20 million drug delivery devices after reports of 2 deaths, 25 injuries, and over 10,000 incidents. 

• Abbot recalled HeartMate Touch Communication System due to risks of system malfunctions. 

Scandals, device recalls, and risk of patient lives has further highlighted the need for better controls, traceability, and more thorough pre-market testing and post-market surveillance. 

Furthermore, as technology develops, the discrepancies between systems will create further difficulty in tracking devices. Discrepancy creates a lack of knowledge, and a lack of knowledge puts patients at risk and creates both financial and reputational losses for healthcare units.  

The MDR has undergone key changes since its implementation. 

The MDR changes: what you need to know 

1.Classification of Devices: 

Devices are classified based on the risk they pose, ranging from low-risk (Class I) to high-risk (Class III). The classification ensures that higher-risk devices undergo more rigorous scrutiny, reducing risk for patients. 

2. Clinical Investigations: 

The MDR also mandates thorough clinical investigations to provide strong evidence of a device’s safety and performance. These investigations must be authorised and monitored by regulatory authorities. 

3. Data Analysis: 

Continuous analysis of data related to the safety and performance of medical devices is required to identify and mitigate risks promptly. 

4. Post-Market Surveillance: 

Manufacturers must implement extensive post-market surveillance systems to monitor devices after they are available on the market, ensuring ongoing safety and effectiveness. 

5. Measures to Protect Public Health: 

The MDR enforces measures to protect patients and public health, such as ensuring the traceability of devices and maintaining transparency through detailed labelling and implant cards for patients. The UDI is a crucial part of the MDR as it allows an enhanced ability to track devices throughout their lifecycle, from manufacturer to disposal. Now, devices must have the correct labelling with both static and dynamic information packs (version, model, batch number, etc), and conform to the European Database on Medical Devices (EUDAMED). 

All legacy devices must be MDR compliant by the end of December 2028. 

But what about the UK? 👇 

UK Medical Devices Outcomes Registry (MDOR) 

The UK has launched the Medical Devices Outcomes Registry (MDOR). This initiative, like the EU’s MDR, aims to improve medical device traceability, post-market surveillance and provide comprehensive data on their performance and safety across the UK. 

Why was the MDOR introduced? A regulatory landscape post-Brexit  

In a post-Brexit landscape, industries face the challenge of regulatory uncertainty; with decision-makers contemplating whether to follow existing EU laws, or to create new ones. If they choose the latter, they must carefully deliberate the implications on each industry, trade, costs, and international competitiveness.  

There is a great risk when deviating from previously established standards, so the newly established MDOR have been closely aligned with the EU MDR, but with some differences to suit local requirements.  

There are two key reasons for the establishment of the MDOR:  

• Recognition of CE Marked Devices: the UK will continue to recognise CE marked devices, streamlining the approval process by aligning with EU and international standards. CE marked devices are products that comply with the health, safety, and environmental protection standards for products sold within the European Economic Area.  

• UK MDR and MHRA: post-Brexit, the UK has had to establish its own set of regulations, closely aligned with the EU MDR, but tailored to local requirements.  

Furthermore, there are plans for to introduce Post-Market Surveillance (PMS) requirements in 2024. This includes mandating rigorous data collection, periodic reviews, and serious incident reporting to detect and address safety issues earlier.  

The UK government has mandated that all trusts across England should adopt barcode scanning of high-risk medical devices by March 2024. In the complex landscape of MDR and MDOR compliance, healthcare trusts and hospitals could benefit from partnering with external companies. With long-standing expertise and advanced solutions, Athera Healthcare supports this transition and ensures compliance. 

Athera FingerPrint is a comprehensive traceability solution, serving as the national solution for the HSE in Ireland and for trusts and private hospitals across the UK. FingerPrint provides complete end-to-end visibility of your surgical equipment using RFID and barcode scanning, all accessible through an intuitive dashboard.  

Athera’s partnership approach empowers healthcare teams during times of change, with expert support from ideation to implementation, ensuring seamless adaptation to new regulatory requirements like the MDR and MDOR.  

The transition period, what you need to know:  

The UK MDR has been amended to allow CE marked medical devices to be sold in Great Britain until June 2028 for general devices and June 2030 for in-vitro diagnostic devices (IVDs). This transition aims to ensure continued access to safe medical devices, while new regulations are being implemented. 

The MDR will have a significant impact on hospitals, whereby they must ensure compliance with these regulatory requirements to avoid significant risks and penalties: 

• Robust Compliance Processes: 

• Implementing processes to ensure clinical evidence, transparency through labelling, and implant cards for patients. 

• Full Traceability: 

• Ensuring full traceability of implants and instruments used on patients, from manufacture to disposal. 

• Traceability can be achieved using advanced software like Athera FingerPrint. 

What are the consequences of non-compliance? 

Non-compliance with these regulations can lead to: 

• Fines and penalties. 

• Legal actions and litigation. 

• Device recalls and lack of visibility of devices used on patients. 

• Reputational damage. 

• Poor patient safety, potentially leading to serious health risks, incidents, or patient harm. 

Concluding thoughts: 

Triggered by technological advancements and past regulatory failures, the introduction of the MDR and MDOR mark a significant transformation in the medical devices landscape for the EU and UK, helping to address critical issues in device traceability, safety, and accountability.  

By classifying devices based on risk, mandating thorough clinical investigations, and enforcing reliable post-market surveillance, the regulations aim to protect patient and public safety, while creating a framework that enables healthcare units to also protect themselves from financial and reputational damage.  

Regulatory compliance is much more than ticking a box; it’s the difference between positive patient outcomes and a scandal, which can result in patient health risk, reputational damage, financial loss – the list is endless. 

Overall, the MDR and MDOR represent a comprehensive, international effort to unify a previously disparate industry, setting higher standards for safety, performance, and transparency. As the healthcare sector adapts to these changes, the MDR and MDOR will play a crucial role in fostering real progress. 

Athera FingerPrint has played a key role in fostering this progress by empowering healthcare organisations across the UK and Ireland with comprehensive, compliant traceability software and consumables. FingerPrint stands as a leading solution in supporting the MDR/MDOR regulatory frameworks, and are trusted by the HSE in Ireland, as well as countless private and public hospitals across the UK.