EU MDR Overview
The European Union Medical Device Regulation governs the safety, quality, and performance standards for medical devices marketed within the EU. As of 2017, the EU MDR has replaced the previous Medical Device Directive (MDD) and aims to enhance patient safety and streamline the regulatory process for medical device manufacturers. By 31 Dec 2028, medical device companies are expected to demonstrate compliance with the stricter regulations put forth by the EU MDR.
Specific transition timelines are dependent on the risk classification of the medical device.
| Transition timeline | Devices |
|---|---|
| 26 May 2026 | Class III custom-made implantable devices |
| 31 December 2027 | Devices covered by valid MDD/AIMDD Certificates (as of 2023/03/20) and that are Class III, or Class IIb implantable devices excluding well-established technologies (WET) under MDR |
| 31 December 2028 | Devices covered by valid MDD/AIMDD Certificates (as of 2023/03/20) and that are Class IIb devices (excluding Class IIb implantable non-WET), or Class IIa devices, or Class I sterile devices or Class I devices with a measuring function
Devices that did not require Notified Body certification under the MDD and for which the declaration of conformity was drawn up prior to 26 May 2021, but now require Notified Body certification under the MDR |
Here is an EU MDR overview and how it compares to the MDD:
- Stricter classification rules: Certain Class I devices may now be recognized as Class II.
- Increased requirements for clinical evidence: Device manufacturers that do not have sufficient clinical data may have to remove their products from the market.
- Enhanced post-market surveillance: To enhance traceability of medical devices throughout their lifecycle, companies must comply with new requirements for Unique Device Identification (UDI) and the European Database on Medical Devices (EUDAMED).
EU MDR vs. FDA Auditing
If your product is already FDA approved in the states, here are the areas you may need to address for market approval in the EU:
- Class II and Class III medical device manufacturers must undergo conformity assessments by a Notified Body, which is an independent third-party organization designated by an EU member state.
- Lower risk devices previously approved by the FDA through a 510(k) clearance will likely require more extensive clinical data to demonstrate patient safety in the EU.
- Under the EU MDR, medical device companies must obtain a CE (Conformité Européene) mark to signify that products meet conformity criteria.
- The EU MDR mandates the use of UDI for enhanced post-surveillance systems to track product safety and efficacy for the duration of the product life cycle.
The FDA or EU can require inspections or hold different specification criteria depending on the class of your device and related risks. Medical device manufacturers are expected to demonstrate evidence for conformity in accordance with the respective agency’s requirements.
Read more about our recommended EU MDR transition strategies.
EU MDR Requirements
The recent EU MDR updates have set a new standard globally for the regulation of medical devices. The new risk-based classification system categorizes devices based on intended use replacing the decision tree method previously used in the MDD. This brings increased scrutiny for devices Class II and higher.
Here are the requirements companies are now expected to meet for CE approval and EU market access:
- Article 15 of the MDR requires companies to appoint a Person Responsible for Regulatory Compliance (PRRC). Ideally, this is a senior personnel with a high-level of expertise in regulatory affairs and QMS management.
- Companies must have an authorized representative based in the EU as an acting liaison between EU regulatory bodies and the company manufacturer.
- Manufacturers will be subject to conformity assessments by EU appointed notified bodies who now have stricter review criteria covering technical documentation, design, manufacturing processes, and clinical data.
- EUDAMED registration. Manufacturers are required to link their unique device identifier (UDI) in the European Database on Medical Devices. Post-market surveillance trends must be reported to EUDAMED to enhance transparency and traceability.
Additional software requirements. Medical device software (MDSW) requirements are all those discussed, with added complexities. Recently, the European Commission put out the MDCG-2019-11 guidance document for software manufacturers to define the criteria for software classification and qualification. Depending on MDSW classification, certain softwares may require an independent regulatory process. In some cases, conformity assessments of software may be required separate from the device itself.
Though the EU MDR updates serve to improve product quality and patient safety, they impact companies with products currently on the market or those who have been working tirelessly to bring a product to market.
Latest EU MDR Updates
This year it was announced that total compliance with the new EU MDR regulatory requirements will be extended from 2024 to 2028 due to potential device shortages. Note that dates are dependent on the risk classification of the device. Some companies have faced significant challenges in trying to maintain EU MDR compliance and are willing to remove their products from the EU market. The European Commission however, recognized the potential negative impact to the public’s health and decided on another legacy extension.
This most recent extension follows a previous extension back in 2021 due to resource and supply chain disruptions caused by the COVID-19 global pandemic. Regardless of extension reasons, companies should be taking advantage now of the extra time to bring their manufacturing processes and QMS into EU MDR compliance.
QA Consulting has a 100% success rate in FDA audits and conformity assessments by EU Notified Bodies. Consider partnering with us to streamline your product’s transition to the EU market.
Learn more about EU MDR Regulatory Strategy.
Transitioning into EU MDR
The EU MDR updates impact many companies who now have to alter their manufacturing processes and implement PMS systems to meet the stricter regulations. Fortunately, the transition extension that was recently announced gives companies more time to reach compliance.
Here are some tips for a streamlined transition to EU MDR compliance:
- Read through the EU MDR requirements. Significant changes have been made to EU medical device regulations. Start by familiarizing yourself with the new regulatory framework.
- Determine your device classification. Review the updated classification criteria and assess where your product fits. Certain devices that were previously Class I under the MDD may now be considered Class II and require conformity assessment by an EU notified body.
- Update your technical documentation. Once your device has been classified, you must demonstrate conformity with the new regulations. You will likely need to revisit your product’s design, risk assessment, performance and quality standards, and provide additional clinical efficacy data.
- Implement a post-market surveillance system. The EU MDR emphasizes the importance of post-market surveillance, requiring ongoing monitoring of device safety and performance throughout its lifecycle. Develop and implement an appropriate system to maintain traceability of your product by assigning a Unique Device Identifier (UDI) and updating your labeling and packaging to comply with UDI requirements.
- Seek the services of a notified body. This will involve auditing your quality management system, reviewing technical documentation, and potentially conducting on-site inspections.
- Solidify a relationship with an authorized representative. Here you will need to understand the roles and responsibilities of economic operators, which include manufacturers, authorized representatives, importers, and distributors. Ensure that you have appropriate agreements and processes in place with these entities to meet the requirements of the EU MDR.
- Plan accordingly! Despite the transition extension period, complying with EU MDR medical device regulations is challenging and time consuming. Set realistic timelines for each milestone of your transition journey.
Our professional team has addressed all of the above milestones and is prepared to help your company operate with higher quality and comply with EU MDR requirements.
Lean into our EU MDR regulatory expertise.
