Keeping up with quality requirements before and after the MDR 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 optimise their QMS (Quality Management System). MDR has formalised 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 organise and implement a compliant QMS well in advance of the deadline.
MDR impact on Quality Management Systems
While complying with Standards such as ISO 13485:2016 - Medical Devices - Quality Management Systems - Requirement for Regulatory Purposes is important, the new MDR criteria expands upon this. 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
Document Storage Retention
General Safety and Performance Requirements
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 meet MedDev quality requirements
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 authorised 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 and the ongoing commitments
More than just a rush to be compliant by the EU MDR transition date, prepare yourself and your company for success throughout all stages. Achieving and staying compliant with the new regulations through investing in the right Standards and processes can make a world of difference.
Understanding ISO 14971:2019
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The third edition of ISO 14971:2019 was published in December 2019 and provides a thorough process for manufacturers within the medical device industry to assess, monitor, and control risks in the creation and use of a medical device.
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