MDR Transition: Greatest Impacts on Medical Device Manufacturers

Amidst the ongoing evolution of the medical device industry, the MDR transition has become a pivotal focus. The Medical Device Directive 93/42/EEC (MDD) was established in the 1990s to regulate medical devices and focused on launching them onto the market. Subsequently, the industry has evolved to include the launch of several high-technology equipment, robotic surgical techniques, software-based diagnostics and treatment planning, as well as mobile app-based support systems to name a few. To keep up with the evolving trends in the industry and establish guidelines to manage the full medical device life cycle with emphasis on traceability, clinical data, and patient safety, Medical Device Regulation (EU) 2017/745 (MDR) was introduced in 2017. Manufacturers have been given sufficient time to transition from the MDD regulation to the MDR requirements. 

This article covers 5 key areas of the MDR for medical device manufacturers to consider when transitioning from the MDD. 

1. Risk and Rules-Based Classification System 

2. Clinical Evaluation  

3. Vigilance Reporting 

4. Labeling and IFU  

5. Harmonized Standards and SOPs 

Risk and Rules-Based Classification System

While the conformity assessment route remains the same for both regulations, the MDR has a more extensive risk classification rule set (Annex VIII 22 rules MDR vs 18 rules MDD) for determining product classification. The updated classification rules include Class I medical devices that need Notified Body Approval if they are Sterile (Class Is), Measuring (Class Im), or Reusable (Class Ir), as dependent on intended use.  

Due to the updated classification rules, manufacturers transitioning to MDR may find that their devices are up classified. Some medical devices that were self-certified Class I under the MDD, are now classified to require notified body approval. This trend of up-classification is seen in software and implantable products, for example.  

Clinical Evaluation for Medical Devices

Clinical Evaluation is one of the areas manufacturers have to take special care of as they transition to MDR regulations as it has financial implications requiring additional budgets and resources for investigations, studies, surveillance, surveys, etc. 

Stringent Requirements Under the MDR

While Part 1 of Annex X of MDD, MEDDEV 2.7/1 describes the Clinical Evaluation Requirements, under the MDR, Article 61 and Annex XIV provide more stringent requirements. The impact of the regulation is high in delineating documentation for Clinical Evaluation Plan (CEP), Clinical Evaluation Reports (CER), Post Market Surveillance (PMS), Period Safety Update Report (PSUR), Post Market Clinical Follow-up (PMCF), Summary of Safety and Clinical Performance (SSCP) as based on Risk Class, and Clinical Data Collection from Investigations. The regulation also puts impetus on Notified Bodies for stringent evaluation of the same. These functionalities have been integrated into the Quality Management System via ISO 13485 and the Risk Management System via ISO 14971. 

Frequency of Document Updates

In addition to detailing the document requirements related to clinical evaluations, the MDR also provides clear guidelines for the frequency of updating the CER, PMS Report, PSUR, etc. Manufacturers of Class I and Class IIa devices are required to update their Clinical and Post Market documents every two years while Class IIa implantable, Class IIb and Class III devices are required to update annually. Additionally, for Class III devices and implantable devices, the PMCF and SSCP are to be updated at least once per year, and a provision provided on the label and IFU will allow the end user to access the data (Ex. A QR Code or website link for the SSCP results of the device on the label and IFU as per Article 32). 

Vigilance Reporting

The MDD set guidelines for reporting events and the responsibilities of the competent authorities for the same. 

Following the transition to the MDR, the following changes have been implemented:

• • • The number of exemption rules has been reduced.
    • Manufacturers must analyze if the reportable event is “serious” or “non-serious”, “adverse event” or “serious adverse event”. 
    • Manufacturers will be required to report incidents, injuries, and fatalities to EUDAMED that centralizes relevant information so that patients can access more safety information. 
    • The timeline for reporting any event (other than serious public threats or sudden deteriorations that must be reported immediately) has been reduced from 30 days (MDD) to 15 days under the MDR. 

Reduced Exemption Rules 

Under Article 87 of the MDR, points 8 and 9 introduce streamlined procedures for reporting field safety corrective actions and serious incidents: 

• • • Immediate Reporting of Field Safety Corrective Actions: Manufacturers are required to report field safety corrective actions promptly, even in urgent cases where immediate action is necessary to address safety concerns. 
    • Periodic Summary Reports for Similar Serious Incidents: Manufacturers may provide periodic summary reports instead of individual reports for similar serious incidents that occur with the same device or device type, provided that the root cause has been identified or corrective actions have been implemented. This streamlined approach requires coordination with competent authorities to agree on the format, content, and frequency of the periodic reporting. 

These updates aim to facilitate more effective vigilance reporting processes while ensuring timely and appropriate responses to safety issues. By reducing administrative burdens and fostering collaboration with regulatory authorities, manufacturers can enhance patient safety and compliance with regulatory requirements.

Vigilance reporting now requires manufacturers to be more alert and implement a system for continuous monitoring.

Labeling Requirements Under the MDR

During the MDR transition, manufacturers are significantly impacted by the requirement for labels to be in both human and machine-readable formats (Article 27). These guidelines, delineated in Chapter III, Annex I of Regulation (EU) 2017/745, underscore the evolution in labeling and Instructions for Use (IFU) requirements.  

Mandatory Inclusions and Updates

While manufacturers of medical devices selling in Europe are familiar with the requirements from MDD; the MDR has extensive labeling requirements, making it crucial for all manufacturers, including legacy device manufacturers, to prepare for and adopt multi-disciplinary strategies for compliance. Manufacturers (including Class I self-certified) must comply with UDI regulations and incorporate Basic UDI-DI, UDI-DI, and UDI-PI on the device labels (Part C of Annex VI). These changes require manufacturers to update their Declaration of Conformity with the device identifiers and maintain them along with their Single Registration Number (SRN) on the EUDAMED database.

E-IFU Requirements and ISO Compliance

In addition, manufacturers are now required to keep updated on their website the e-IFU and comply with the applicable sections of EU 2021/2226 under Annex I of the MDR (Section 23.1). As stated in the MDR Annex I, Chapter III, 23.1 (f), “Instructions for use may be provided to the user in non-paper format (e.g. electronic) to the extent, and only under the conditions, set out in Regulation (EU) No 207/2012 or in any subsequent implementing rules adopted under this Regulation.” Additionally, manufacturers must incorporate the new ISO 15223-1 approved symbols in their labels and IFU.

In the case of implantable devices, an Implant card must be supplied to the patient (Art 18). Labeling requirements for Procedure Packs have been formally introduced. These require a procedure pack to bear the sterilizer’s name, registered trade name, registered trademark (as applicable) and address. Every individual device within the procedure pack must be accompanied by all information referred to in Section 23 of Annex I, including CE Marking as per Annex V.

Impact on Communication and Global Compliance

As a significant result of MDR transition, most manufacturers are having to update their IFUs to be more specific and in alignment with the clinical data available and the classification rules. Broad and general IFUs are not in alignment with the MDR, and this is affecting manufacturers, not just in selling their devices in the EU: but also, in communicating with Regulatory Authorities globally, where they are required to provide updates and justification for the change in the IFU. In almost all cases, the essence of the IFU remains the same but the wording and intended use are more concise. 

Harmonized Standards and SOPs

For complying with the MDR guidelines, recommendations for following the latest standards (Ex. EN ISO 14971:2019, EN ISO 15223-1:2021, EN ISO 20417:2021, etc) and detailed SOP (Ex. SOPs for developing and updating technical files, General Safety and Performance Requirements (GSPR), and Communication Protocols for updating Competent Authority, Notified Bodies, Economic Operators, End Users, etc) have been provided. Additionally, the period for maintenance of records for non-implantable medical devices has been increased as per Article 56 to 10 years (vs 5 years MDD) while it remains the same as 15 years for implantable devices with the manufacturer.  

Learn More About MDR Transition with MedEnvoy 

These updated regulations can be overwhelming to prepare for, contact our experts at MedEnvoy, who have the necessary experience to help navigate you through the process. If you have any questions regarding transitioning your devices to the MDR or require relevant training/consulting services, get in touch. 

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