• With the medical device industry working hard to update their processes and products to comply with the new MDR regulations, a key focus within the industry needs to be keeping up with quality requirements during this transition.

    • Quality Management Systems before, during, and after the EU MDR deadline

      Quality Assurance Managers within the MedDev space must work to ensure all products and processes meet the new, stricter requirements laid out in MDR. Part of the new MDR requires the medical device industry to update and optimize their QMS (Quality Management System). MDR has formalized the expectations that your QMS, documents, records, product information, risk, etc. are all interconnected. Your QMS will dictate the quality level that your products and processes maintain in transitioning to the new requirements.

      It is important to note that while some devices themselves may be entitled to a 'grandfathering' period, all QMS systems used in the industry must meet MDR regulations by the deadline in May 2021. This means that any audits conducted after the deadline will need to be to the new standard. In order to be compliant after the transition officially takes place, it's important to organize and implement a compliant QMS well in advance of the deadline.

      • MDR impact on QMS

        While complying with Standards such as ISO 13485:2016 is important, this Standard does not ensure that your QMS will be current with the new MDR criteria. Examples of additional areas of QMS introduced by MDR include: 

        • Post-market Surveillance System

        • Periodic Safety Update Report (PSUR)

        • Incidents and Field Safety Corrective Actions (FSCA)

        • Resource Management / Supply Chain

        • UDI and Labeling

        • Regulatory Compliance

        • Document Storage Retention

        • General Safety and Performance Requirements

        • Implantable Devices

        • Clinical Evidence

        • Economic Operators

        • EUDAMED

        There are a few other areas not covered by ISO 13485:2016 that are important to stay on top of. For example, MDR stipulates that a QMS addresses 'a strategy for regulatory compliance including compliance with conformity assessment procedures and procedures for the management of modifications to the devices covered by the system' (Article 10, Clause 9a). 

        The responsibility to know and meet regulatory obligations and keep producing safe products lands on individual companies, not regulatory bodies. As such, MedDev companies must employ individuals that meet certain requirements and are aware of all relevant and applicable regulations. 

        The right team

        To ensure MDR compliance within companies, new EU MDR guidelines dictate the requirements of “the person responsible for regulatory compliance”, i.e. the employees. The guidelines demand that the individual have a relevant degree and at least 4 years professional experience or sufficient work experience to understand and meet the requirements of the Standard's applicable. 

        The guidelines differ for small companies and outline that they may consult with a company that has the necessary regulatory compliance expertise instead of employing them directly. (For more information on these requirements, check Article 15 within MDR) These employees are required for both manufacturers as well as authorized representatives. These employees are responsible for product conformity checks and appropriate QA releases. 

        As these individuals play a crucial role in maintaining quality, it is essential they have access to the Standards they need to do their job correctly. 

        Meeting the deadline

        Make this transition period count before the EU MDR deadline arrives. Prepare yourself and your company for success by achieving and staying compliant with the new regulations. Create quality devices by investing in the right Standards and processes.

        • Medical Devices Standards Management

          Rigid regulatory obligations leave no room for error in the medical devices industry

        • Understanding ISO 14971:2019

          The updated Standard for the application of risk management to medical devices

        • 8 Benefits of Standards

          Discover the benefits to your business

        • Prepare for the EU MDR 2020 transition and beyond. Learn how to reduce risk through efficient quality control.

          CONTACT US