White Paper MDR

Understanding the European Medical Device Regulation (EU MDR)

The European Medical Device Regulation (EU MDR) has brought significant changes to the medical device industry, ensuring stricter safety and performance standards. Compared to the previous EU Medical Device Directive (MDD), the new medical device regulation enforces rigorous clinical evaluation requirements, enhanced post-market surveillance, and stricter conformity assessments.

Manufacturers must now provide substantial clinical evidence demonstrating safety, performance, and clinical benefits before receiving CE certification. The EU MDR also strengthens patient safety by implementing unique device identification (UDI) and improving transparency through EUDAMED. As compliance deadlines approach, companies must prioritize regulatory strategies to meet evolving medical device regulation requirements.

How MDR Impacts Medical Device Companies

The transition from the European Medical Device Directive (MDD) to the European Medical Device Regulation (EU MDR) has introduced stringent requirements for medical device companies. One of the most significant changes is the EU medical device registration process, which now demands comprehensive clinical data, stricter post-market surveillance (PMS), and enhanced traceability.

Companies must conduct conformity assessments for all medical devices, ensuring compliance with the updated classification rules. The clinical evaluation process now requires stronger evidence, making it difficult to demonstrate equivalence with existing CE-marked devices. Additionally, manufacturers must actively collect Post-Market Clinical Follow-Up (PMCF) data and submit Periodic Safety Update Reports (PSURs) for Class II and III devices.

Failure to comply with EU MDR may result in market withdrawal, impacting both business operations and patient safety. Thus, it is crucial for manufacturers to stay updated with evolving medical device regulations, streamline regulatory documentation, and invest in robust clinical data management systems to ensure seamless market access and long-term compliance.

Impact of MDR on Your Device

As of May 25th 2017, the European Medical Device Regulation (EU MDR) has replaced the long-standing Medical Device Directive (MDD). The impact of the Medical Device Regulation (MDR) to the medical device industry is substantial as it requires the re-classification and re-registration of all medical devices currently on the market.

Impact

1)More medical devices will require clinical investigation;
2)Equivalence will be harder to demonstrate;
3)The level of evidence required for medical device studies will be higher
4)There will be more focus on post-market surveillance.

What does it mean for you 

It also means you will need to do a conformity assessment for all your devices currently on the market, be it a syringe or a pacemaker, or remove the product from the market. Additionally, more products will be considered to be a medical device.

Impact Solution

Make sure you are well informed about the new classifications and corresponding clinical requirements of your products as per new Medical Device Regulation (MDR).

In addition, the manufacturer needs to demonstrate it has access to the equivalent device data, which significantly limits its usability. These criteria were also added in the most recent revision of the guidance on the clinical evaluation(MEDDEV 2.7.1 rev.4).

Where medical device clinical studies previously aimed to demonstrate safety and performance, studies under the EU MDR will now also need to show the clinical benefit to patients. This means that clinical trials should be designed with completely different end-points, more complex study setups, and potentially larger sample sizes. Additionally, clinical investigation plans should include details on prevention of scientific bias.

A PMS system shall be used to actively gather and analyse data on the quality, performance, and safety of the device throughout its lifetime. The system should be based on a PMS plan and to be outputted in a report. In addition Class II and III devices should prepare yearly for periodic safety update reports (PSUR) containing the analyses of the PMS data gathered, including data from post-market clinical follow-up.

Regulation (EU MDR) is necessary, particularly in a sector, like the Medical device sector, which exposes countries and people to a risk.

Clinical Data Requirements Under MDR

The MDR regulation has introduced stringent requirements for clinical data collection to ensure the safety and performance of medical devices. Under the EU regulation for medical devices, manufacturers must provide robust clinical evidence demonstrating not only the safety and performance of their devices but also their clinical benefits. This requires compliance with ISO 14155 and Good Clinical Practice (GCP) standards.

Additionally, the need for Post-Market Clinical Follow-up (PMCF) and Periodic Safety Update Reports (PSURs) has intensified, requiring manufacturers to continuously gather and analyze real-world data. Ensuring compliance with these new clinical requirements is essential for maintaining market access in the EU under the Medical Device Regulation (MDR) framework.