Roadmap to EU-MDR compliance and certification has been saved
Roadmap to EU-MDR compliance and certification
Steps, considerations and timelines for manufacturers of medical devices for a timely and smooth transition to the EU-MDR.
The EU-MDR is a significant upgrade to the previous regulatory framework and aims to ensure the highest possible safety and effectiveness of medical devices. Medical devices may now be placed on the European market only if they comply with the applicable requirements as laid down in the EU-MDR. What does this mean for manufacturers and their roadmap to EU-MDR compliance and certification?
The European Medical Device Regulation 2017/745 (EU-MDR) came into effect on May 26, 2021, replacing the previous EU Medical Device Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD). As of this date, all new medical devices must fulfil the EU-MDR requirements. For legacy devices (devices that already existed on the EU market prior to 26 May 2021 requiring notified body involvement under EU-MDR) a transition period applies.
While for high-risk legacy devices (class III and class IIb implantable devices) the transition deadline has been set on 31 December 2027, the transition deadline for medium and low risk legacy devices (class I(m, s, r), class IIa and class IIb) is 31 December 2028. Devices that are Class I under the MDD/AIMDD and that will get a higher classification under the EU-MDR may also take advantage from the transition deadline of 31 December 2028.
These transition periods can only be used under some strict conditions including:
- The requirement that a quality management system (QMS) according to EU-MDR must be set up by 26 May 2024
- A formal EU-MDR application is submitted to a Notified Body by 26 May 2024
- A written agreement with a Notified Body is in place by 26 September 2024.
The EU-MDR application must include the QMS documentation and the relevant information on the device qualification, classification, and the chosen conformity assessment procedure. The technical documentation needed for conformity assessment by the Notified Body can be submitted at a later stage. Essentially this means that by 26 May 2024 manufacturers must be able to show considerable progress for complying with the EU-MDR if they wish to make use of the transition period. One should be aware that the entire certification process could take up to 18 months, or even longer depending on the risk class, the status and maturity of the technical documentation and QMS, and the availability of a Notified Body. Therefore it is strongly advised to plan ahead and anticipate for unexpected setbacks working towards the final application date.
Qualification and Classification: In general, only products that qualify as a medical device are subject to the EU-MDR requirements. The legally binding definitions of a medical device in article 2 of the EU-MDR, as well as exclusions from the scope in article 1(6), serve to distinguish medical devices from other closely related products like in vitro diagnostics, cosmetics and medicinal products. Once the product is qualified as a medical device, it shall be classified as either class I, IIa, IIb or III depending on the intended purpose of the device and its inherent risks associated with the technical design and manufacturing processes. Wrongly qualifying or classifying the device could negatively impact the manufacturer’s regulatory strategy planning in terms of the estimated time, effort, and budget for market introduction. This often leads to increased spend and time-to-market delays.
Gap assessment: All medical devices shall meet the General Safety and Performance Requirements set out in Annex I of the EU-MDR that apply for that device. Applicable (harmonized) standards, common specifications and good practice guidelines should be used as much as possible to demonstrate conformity of the device with these requirements. Manufactures shall identify, assess, and remediate any gaps in the evidence of conformity prior to placing the device on the EU market. A gap assessment on the Technical Documentation (TD) and Quality Management System (QMS) should be performed to identify any gaps or deviations with the applicable regulatory requirements, standards and good practice guidelines.
Remediation action plan: To remediate the gaps identified during the assessment, clear actions should be defined, prioritized, and planned for execution. This includes an assessment of the impact on the TD and QMS, an estimation of efforts for remediation, assignment of action owners, marking of milestones, creation of realistic timelines and identification of critical dependencies.
Notified Body Search, Selection and Communication: Notified Bodies are independent and impartial third-party organizations that perform conformity assessment activities (e.g. testing, inspection and certification) to demonstrate that a medical device conforms to the applicable requirements of the EU-MDR. Although the number of EU-MDR designated Notified Bodies is increasing, the overall capacity of Notified Bodies is not yet sufficient to timely process the large number of EU-MDR applications. Therefore, it is strongly advised that manufactures start early with their search for and selection of an appropriate notified body and to communicate the mutual expectations for conformity assessment of their device(s) in terms of planning, timelines, and the availability of resources.
Remediate/ establish QMS and TD: Depending on the size and structure of the organization, the number of processes and documented procedures and the complexity of the medical device and Technical Documentation, executing the QMS and TD remediation action plan can be an overwhelming task and can easily spiral out of control. To successfully achieve the project goals within budget and timelines a project management approach is necessary. In addition to a systematic and structured way of working for the initiation, planning, execution, and monitoring of the project, establishing a clear governance structure and decision-making process as well as good stakeholder management and communication are key factors for success.
QMS implementation: With the necessary quality management system documentation in place (i.e. the remediated and established quality policy, objectives, manual, procedure, and forms), the manufacturer should start with implementing the changes to the QMS. This generally is a time-consuming and resource-intensive process, requiring significant investment in training and process changes. During the QMS implementation phase the necessary records should be maintained to provide evidence of conformity to requirements and of the effective operation of the QMS.
EUDAMED registration: EUDAMED is the European Data Bank on Medical Devices which contains all the relevant information concerning the lifecycle of medical devices that are made available on the EU market. The information in EUDAMED is captured across the six integrated modules:
- User registration and management
- UDI database and device registration
- Notified bodies and certificates
- Clinical investigations and performance studies
- Vigilance & PMS
- Market surveillance
At the end of 2024 (Q4 2024), the full EUDAMED system will be released and from that moment the use of EUDAMED becomes mandatory for user registration, vigilance reporting and PMS, Clinical Investigation & Performance Studies and Market Surveillance. 18 Months later (Q2 2026), the use of EUDAMED becomes mandatory related to the activities for UDI database and device registration as well as for notified bodies and certificates. Since this will affect some of the organisation’s core processes and operations, manufacturers should not wait until the last minute and plan ahead. They must anticipate early by identifying the applicable EUDAMED requirements and responsibilities and develop the right capabilities in their QMS and supporting information infrastructure and technologies.
Conformity assessment for class I devices should be carried out under the sole responsibility of the manufacturer in view of the low risks associated with the device. This means that the manufactures of class I devices (except for Class Is, Im and Ir) shall self-declare conformity of their devices and apply the CE mark. For class IIa, IIb and III medical devices involvement of a Notified Body is always required. In that case, manufacturers must lodge an application for the assessment for its QMS and TD to the Notified Body. For a successful and timely Notified body assessment and to familiarize the company with the assessment process, it is advised that manufacturers perform the necessary preparations (e.g. readiness checklist and/or mock audit) to ensure that the TD and QMS are in place, meet the requirements of the EU- MDR and are ready for assessment by the Notified Body.
Plan-Do-Check-Act: Once the conformity assessment for the medical device has been successfully completed and the CE-mark has been obtained, the manufacturer must maintain the continued safety and performance of the medical device as well as the continued suitability, adequacy, and effectiveness of the QMS. Moreover, the quality processes should constantly be improved by monitoring, measuring, and analyzing production and post-production/ post-market surveillance information and by identifying opportunities for improvement and the implementation of the necessary changes to the QMS.
Speak to our experts
Deloitte supports medical device manufacturers with the planning and execution of their roadmap to EU-MDR compliance. Our involvement could range from strategic advice to hands-on support across these various phases and activities. This helps manufacturers achieve compliance with the EU-MDR in time so that they are able to (continue) placing their medical device(s) on the European Market.