How an ISO 13485 QMS Facilitates EU Medical Device Regulation Implementation
The implementation of the EU MDR is a significant challenge for manufacturers. The MDR requires manufacturers to develop a suitable QMS which is assessed as part of the conformity assessment procedure. A formal assessment is performed by a notified body for devices with the exception of Class I. Class I devices however, still require an adequate QMS in order to issue a declaration of conformity and self-certify to MDR Compliance.
EN ISO 13485:2016 is a harmonised standard which allows for the “presumption of conformity” with the applicable legal requirements of the EU MDR. Although following harmonised standards is voluntary, following them is considered an efficient way to show product conformity with the requirements and achieve certification.
An EN ISO 13485 compliant QMS plays a pivotal role in this process by:
Ensuring Compliance: An EN ISO 13485 compliant QMS helps manufacturers align their processes with the EU MDR requirements, facilitating a smoother transition.
Document Control: Proper document management, a key aspect of EN ISO 13485 , ensures that all necessary documentation required for EU MDR compliance is up to date and readily accessible.
Compliance with the EU MDR involves not only updating the QMS but also ensuring that all medical devices placed on the European market meet the new regulatory requirements, including those related to product classification, clinical evaluation, post-market surveillance, and labelling, among others.
Here's how EN ISO 13485 aligns with and supports compliance with the EU MDR:
Risk Management: Both EN ISO 13485 and the EU MDR emphasise the importance of risk management in medical device manufacturing. EN ISO 13485 includes specific requirements for risk management processes, such as risk assessment, risk analysis, and risk mitigation. These align with the risk-related provisions in the MDR, ensuring that manufacturers address safety and performance risks effectively.
Documentation and Record Keeping: EN ISO 13485 mandates comprehensive document control and record-keeping processes. This aligns with the EU MDR's requirements for maintaining detailed documentation throughout the product lifecycle, including design and manufacturing records, clinical evaluation reports, and post-market surveillance data.
Product Lifecycle Management: EN ISO 13485 promotes a systematic approach to managing the entire product lifecycle, from design and development to production and post-market activities. This closely aligns with the EU MDR’s focus on lifecycle management, including requirements for clinical evaluation, post-market surveillance, and vigilance reporting.
Compliance with Regulatory Requirements: EN ISO 13485 requires organisations to demonstrate compliance with applicable regulatory requirements. Manufacturers that adhere to EN ISO 13485 are more likely to be prepared for regulatory audits and assessments under the EU MDR. EN ISO 13485 can serve as a foundation for aligning with EU MDR-specific regulatory requirements.
Change Control: Both EN ISO 13485 and the EU MDR emphasise the importance of change control processes to manage modifications to products or processes. Manufacturers that implement EN ISO 13485-compliant change control procedures are better equipped to address changes required to comply with evolving MDR requirements.
Post-Market Surveillance: EN ISO 13485 encourages manufacturers to establish robust post-market surveillance processes. This aligns with the EU MDR's increased emphasis on post-market surveillance, including the need for continuous monitoring of device performance and safety.
Internal Audits and Management Review: EN ISO 13485 mandates regular internal audits and management reviews to assess the effectiveness of the QMS. This aligns with the EU MDR's requirements for manufacturers to conduct internal audits and reviews of their quality systems to ensure ongoing compliance.
Supplier Management: EN ISO 13485 includes requirements for the evaluation and control of suppliers, aligning with the EU MDR's emphasis on supply chain and subcontractor oversight to ensure the quality and safety of medical devices.
Clinical Evaluation: While EN ISO 13485 does not specifically address clinical evaluation requirements, it provides a framework for quality management that supports the development of clinical evaluation reports and the maintenance of clinical data required under the EU MDR.
Post-Market Surveillance Reporting: EN ISO 13485 encourages the establishment of processes for complaint handling and vigilance reporting, which align with the EU MDR's requirements for manufacturers to report adverse events and incidents.
EN ISO 13485 serves as a valuable tool for medical device manufacturers seeking to meet the quality management requirements of the EU MDR. While EN ISO 13485 is extensive, it is not a substitute for EU MDR compliance, it is a harmonised standard that provides a structured framework and best practices that closely align with many of the EU MDR's key provisions, helping manufacturers prepare for regulatory assessments and ensuring the safety and effectiveness of their devices in the European market.
Timelines for EN ISO 13485 Alignment with MDR
The EU MDR was adopted in April 2017 and entered into force in May 2017, replacing the previous Medical Device Directive 93/42 EEC (MDD) and Active Implantable Medical Device Directive (AIMDD). Medical device manufacturers were required to transition from the MDD to the EU MDR and ensure that their QMS and products complied with the new regulations by May 26, 2021. This transition period allowed manufacturers to adapt to the more stringent and comprehensive regulatory requirements of the MDR.
On 20 March 2023, Regulation ((EU) 2023/607) amending the EU MDR and IVDR was published in the Official Journal of the European Union (OJEU) with immediate effect. The amendment did not change any of the current safety and performance requirements, but aims to facilitate the transition to the new EU regulatory framework to allow for more time to certify medical devices and to mitigate the risk of shortages.
It extends the EU MDR transition timelines while also recognising, valid previously issued MDD, AIMDD Certificates for the duration of those longer transition timelines. This allows manufacturers to continue placing their devices on the market based on compliance to the Directives while they continue the transition of their devices to the EU MDR.
It is important to note that the longer transition timelines apply only to devices that are transitioning to EU MDR and meet other specific conditions set out in the Regulation
A staggered and conditional extension of the transition period was introduced according to the type of device as presented below:
Manufacturers who are currently transitioning their products to MDR need to be aware of the critical deadline in May 2024 when they will be required to put in place an EU MDR QMS.
EN ISO 13485:2016 +A11:2021 is the most recent harmonised version of the standard that describes the relationship between the clauses of the standard and the requirements of the EU MDR. This standard has a 3 year transition period, therefore manufactures with an EN ISO 13485 certified QMS should ensure they have reviewed and planned appropriate certification activities inline with these critical deadlines.
It is essential to start the certification process well in advance to avoid any last-minute compliance issues.
The next instalment of our blog will focus on the ‘Importance of Internal Audits and Management Reviews’.