European Union Medical Device Regulation (EU MDR) Overview
In the modern world, the life sciences sector is going through a period of unprecedented regulatory change affecting organizations involved in pharmaceuticals, medical devices, and in-vitro diagnostics. The European Union Medical Device Regulation (EU MDR), a robust, transparent, predictable and sustainable regulatory framework for medical devices, ensures high standards of quality and safety being produced in or supplied into Europe. By improving the safety and performance of medical devices, the EU MDR regulations are intended to improve the safety of healthcare and the performance of medical devices in Europe.
To do this, the EU MDR regulations aim to create a new and improved landscape for the quality and safety of medical devices with the following new guidelines:
- An independent assessment of all medical devices for safety and performance before they can be marketed in the EU
- More transparent information on the benefits for patients, residual risks, and a comprehensive assessment of the overall risk/benefit ratio
- Clear rules to enable standardization and support simpler and less complex trading between EU member states; those that do not comply will be penalized
- New rules to support patient-oriented innovation and take particular account of the specific needs of the many small and medium-sized manufacturers in this sector
- Place further responsibilities on “Notified Bodies”, an independent third party that performs conformity assessments for medium and high-risk devices
Benefits of European Union Medical Device Regulation – EU MDR
The EU MDR is the European Union Medical Device Regulation 2017/745 released in 2017 by the European Parliament and the Council of the European Union. The intent of the EU MDR regulations is to ensure a high standard of safety and quality for medical devices as well as standardizing data and technological advances through an EU database (EUDAMED). EU MDR will enforce:
- Strong pre-market control of high-risk devices
- A new risk assessing system for medical devices diagnosis based on international guidance
- Greater transparency through the establishment of a comprehensive EU database of medical devices (EUDAMED)
- Improved device traceability through the supply chain from its manufacturer
- Collect data of the real-life use of the devices
- Better coordination between the EU Member States
What is MDR certification?
MDR certification validates that the device meets all of the regulatory requirements for European Union medical devices and it is indicated by a CE Mark. Companies should implement a Quality Management System (QMS) for medical devices to be certified. Many companies use ISO 13485-based QMS, which is ideal as it relates to the MDR EU regulation, and this is the only QMS standard on the EU harmonized lists.
What is MDR 2020?
MDR, a new set of regulations effective from May 2020, replaced the Medical Devices Directive (MDD) and Active Implantable Medical Devices (AIMD) Directive, to improve consistency and increase patient safety. Compliance with the new regulation is compulsory for all medical device companies who produce and distribute medical devices in Europe.
Key changes and updates in Eu MDR
After almost 25 years, the EU MDD witnessed a fundamental revision. One of the important changes is the certification for all MDD devices. The final date for all MDD-certified devices to be certified under the new MDR is May 25, 2024. The new legislation will impose regulatory obligations, unlike EU MDD. The new EU MDR will be a transparent, robust, sustainable, and predictable regulatory framework that sets the rules for product classification, clinical evaluation process, PMS (Post-Market Surveillance) system, QMS, notified bodies, the person responsible for regulatory compliance, economic operators, EUDAMED, and more.
How is EU MDR structured?
The new EU MDR document consists of 174 pages including a 13-page introduction, followed by 123 articles in 10 chapters (79 pages), and 17 annexes (80 pages). The new regulations are considerably longer as the AIMD has also been integrated into the new MDR, and is more detailed in comparison with the MDD, which was 60 pages long. Besides, 42 implementing acts have been published to clarify or implement the MDR and 12 delegating acts used to modify or amend it.
The Medical Device Regulation (MDR) involves mandatory requirements for user facilities, manufacturers, and importers to report particular device-related events and product problems to the FDA.
- User Facilities: User facilities must report a suspected medical device-related death or serious injury to both the FDA and the manufacturer.
- Manufacturers: Manufacturers are required to report to the FDA when they find out that any of their devices may have caused or contributed to a death or serious injury or if their device has malfunctioned.
- Importers: Importers report to the FDA and the manufacturer when they learn that one of their devices may have caused or contributed to a death or serious injury or if their imported devices have malfunctioned.
EU MDR is configured to be an amended version of MDD, with the key difference that MDR influences and provides effectiveness to all EU member states, increasing the standards on quality and safety measures.
EU MDR Post Market Surveillance
The MDR defines post-market surveillance as a proactive and systematic process that manufacturers implement and carry out in order to take corrective and preventive action (CAPA) in accordance with the information on medical devices and their performance. Post-market surveillance (PMS) is a collection of processes and activities of the regulatory framework used to monitor the performance of a medical device in Europe. These activities are aimed to generate information to find out device design or usage problems and accurately portray the device behavior and clinical outcomes.
The purpose of the post-market surveillance system is to gather, record and analyze relevant data on the quality, performance and safety of a device throughout its entire lifetime so that manufacturers can update the risk-benefit assessment and initiate appropriate measures immediately. A robust PMS program provides:
- early warning of a problem
- disclosure of low-frequency events
- long-term performance of the device
- monitors the effect of design changes
- corrective action
- compliance with relevant legislation
Who regulates medical devices in Europe?
The Medical Devices and the In-Vitro Diagnostic Devices Regulations introduced new responsibilities for the European Medicines Agency (EMA) and national competent authorities in the assessment of medical devices. EMA has published a series of guidance documents to help applicants prepare for obligations imposed by the new EU regulations on medical devices. The Agency is operating with the EU regulatory network and with stakeholders to ensure a smooth transition to the new regulatory framework from the pharmaceutical and medical device industries, including notified bodies.
The European Parliament and the Council of the EU adopted a proposal on 23 April 2020 to extend the transitional period of the Medical Devices Regulation by one year, until 26 May 2021 to avoid shortages of medical devices during the ongoing COVID-19 pandemic due to the limited capacity of national competent authorities or notified bodies to implement the Regulation.
How can ComplianceQuest help you?
ComplianceQuest’s QHSE solutions help Medical Devices & Diagnostics organizations ensure product quality, safety and enterprise-wide compliance with regulatory and product safety requirements and organizational SOPs. ComplianceQuest EQMS solution provides ISO requirements and best practices by automating your entire quality management system requirements while maintaining full traceability. ComplianceQuest helps you organize your company’s MDR requirements improving productivity while easily helping auditors and notified bodies to find what they need quickly and effortlessly. ComplianceQuest also helps medical devices companies minimize the cost of compliance, while fully meeting FDA requirements.
Frequently Asked Questions
When does EU MDR go into effect?
The transformation from the EU MDD directive to the EU MDR regulations continues for a four-year period and ends on 26 May 2021 to comply with the new regulations immediately. Any new medical devices will need to be certified to the new EU MDR regulations after this date. Existing MDD-certified medical devices will be having an additional transition period until May 2024 to change their technical documentation to comply with the new MDR EU regulations.
How does the new MDR affect your QMS implementation and maintenance?
Medical devices manufacturers establish, document, implement, and maintain a quality management system (QMS) to ensure product quality and conformity to achieve compliance with the provisions of the new regulations. ISO 13485 QMS provides a framework to address management responsibilities, improve the effectiveness of processes, and promote product conformity for designing a medical device QMS. The main changes to the new standard include:
- additional responsibilities and commitment of the management members
- better controls over supplier and outsourced activities
- a risk-based approach to the QMS processes and
- risk management throughout the product life cycle
New changes and requirements have a direct impact on your QMS including the changes that medical device manufacturers have to adapt to. Since it’s increased the importance of risk and safety, the new MDR includes medical purpose devices and active implantable devices.
Will the MDR require enhanced device traceability?
The new MDR includes Unique Device Identification (UDI) to facilitate the traceability of all medical devices sold in the region. Devices must be detected with a device identifier (DI) and each batch or production series of the product will be marked with a production identifier (PI). The MDR also brings out new databases for product registration, clinical investigations, and post-market surveillance. The EUDAMED database allows notified bodies, medical device companies, consumers, regulators, and other stakeholders to access the recent data on medical devices for sale in Europe.
What is the time frame for complying with MDR post-market surveillance requirements?
Complying with MDR post-market surveillance requirements will apply after the date of application May 26, 2021.