Is Your Client Ready for the EU MDR Deadline?
COVID-19 introduced some amendments to the European Union Medical Device Regulation (MDR) application date. As such, applicants have until May 26, 2021, to comply with the newest regulation. Are your clients ready for the EU MDR deadline?
According to the European Commission’s Fact Sheet for Manufacturers of Medical Devices, “The new medical devices Regulation (2017/745/EU) (MDR) and the in vitro diagnostic medical devices Regulation (2017/746/EU) (IVDR) bring EU legislation into line with technical advances, changes in medical science, and progress in law making.”
EU MDR impacts medical device manufacturers in a few key areas, including the designation of Notified Bodies and the introduction of the Unique Identification System.
“The new Regulations create a robust, transparent, and sustainable regulatory framework, recognized internationally, that improves clinical safety and creates fair market access for manufacturers,” continues the European Commission.
In recent months, Qualio has helped hundreds of growing medical device manufacturing organizations to streamline EU MDR adoption and compliance. In fact, our electronic quality management system (eQMS) supports organizations in the areas of process documentation and review. Many startups and scale-ups benefit from the quality process automation that our eQMS provides.
How to Prepare Your Client for the EU MDR Deadline
As a medical device consultant, it is your duty to guide your clients toward successful EU MDR activation. Unfortunately, in a recent survey conducted by KPMG and the Regulatory Affairs Professionals Society (RAPS), respondents cite “lack of guidance and lack of internal resources” as major barriers to EU MDR adoption and compliance. Moreover, 48% of respondents have not begun preparing an EU MDR strategy.
“For companies that have yet to develop a strategy, it is critical to start with understanding the requirements and developing a roadmap for compliance,” recommends KPMG and RAPS.
In this scenario, it is recommended that the medical device organization assign a person responsible for EU MDR compliance. In this way, the organization can ensure that all activities related to EU MDR compliance, as well as post-market surveillance activities, are carried out with consideration toward new and evolving requirements. Unfortunately, only 40% of participating organizations have designated the Person(s) Responsible for Regulatory Compliance.
Are your clients behind the curve? The European Commission’s Implementation Model for Medical Devices Regulation outlines the key actions that medical device organizations should commit to now to achieve EU MDR compliance. Additionally, here is a list of the major areas where you and your team should dedicate the most focus.
With the application deadline fast-approaching, we recommend performing an internal gap assessment as soon as possible. Unfortunately, the European Commission does not offer any guiding materials beyond what’s included in the MDR. For this reason, medical device organizations may need to leverage third-party resources such as the British Standards Institution’s (BSI) Medical Device Regulation Readiness Review.
In short, the gap assessment will help organizations to do the following:
- Identify the most important EU MDR requirements
- Identify gaps in EU MDR compliance
- Identify activities to secure EU MDR compliance
After reviewing major EU MDR requirements and benchmarking the organization’s activities against new regulations, the medical device organization will have a better understanding of required processes and practices under new MDR guidance.
Qualio Plus Audit supports growing medical device organizations through an in-depth EU MDR gap assessment. With access to expert quality assurance support and guidance, Qualio makes it simple and easy to conduct pre-assessment activities.
2. Quality Management System
Does the QMS meet standards and practices enacted under EU MDR? These new regulations place an increased emphasis on documentation and record-keeping. For this reason, systems must properly track and record manufacturing processes.
Unfortunately, finding the right QMS is easier said than done. In most cases, it starts with understanding the internal infrastructure of the medical device organization. What does it need in a QMS? How does the QMS align with EU MDR requirements?
To guarantee the right investment, prioritize QMS vendors that offer the following:
- Document Management
- Product Development
- Regulatory Events
Learn why thousands of medical device organizations trust Qualio.
“As consultants, we have the pleasure of working with the good, the bad, and at times, the ugly when it comes to quality management software,” says Devine Guidance International President and CEO Dr. Christopher Devine. “Qualio simplifies the approach to effective quality management. The web-based software is intuitive, which greatly reduces the amount of time required for users to come up to speed with a new platform.”
3. Notified Bodies
For medical device manufacturing organizations seeking to achieve EU MDR compliance, the organization must work closely with appointed Notified Bodies. These guiding organizations are responsible for assessing the organization’s EU MDR preparedness. Typically, this involves a close examination of the product itself.
According to the European Commission’s Implementation Model for Medical Devices Regulation, organizations must “contact the selected Notified Bodies and determine their capacity and availability to service the implementation plan.”
Here is a complete list of Notified Bodies.
4. Regulatory Training
To maximize the organization’s chances for EU MDR compliance, we recommend committing to ongoing regulatory training. Fortunately, there are a variety of recorded webinars, digital conferences, and training to help ensure MDR preparedness.
We recommend consulting the following organizations for support and training:
- The National Sanitation Foundation (NSF)
- The British Standards institution (BSI)
- Société Générale de Surveillance (SGS)
Additionally, Qualio offers expert EU MDR support. In fact, our consultative and advisory partners routinely leverage our in-depth training and support services.
Finally, medical device manufacturing startups and scale-ups must develop monitoring and reporting protocols to manage the MDR implementation plan. For most medical device manufacturing organizations, risk management is the biggest area of concern.
The EU understates the importance of risk management in Article 10 of Regulation 2017/745/EU. In short, organizations are required to implement a risk management system for each medical device. While the EU doesn’t set forth specific risk management requirements, it is recommended that organizations follow risk management procedures and processes as enforced and outlined in ISO 14971.
Achieve EU MDR Compliance With Qualio
Are your clients primed for EU MDR compliance? A proactive approach to EU MDR readiness ensures that the medical device manufacturing organization has all the tools, resources, and processes to guarantee a smooth and seamless transition. For many growing startups and scale-ups, an investment in an enterprise-class eQMS is the first step toward preparing for EU MDR compliance.
For this reason, Qualio continues to be a top choice among industry-leading medical device manufacturing consultants and advisors. With access to robust documentation, training, and reporting tools, our eQMS enables users to manage teams’ quality processes more effectively. Additionally, when working with multiple accounts, the system gives consultants and advisors a bird’s-eye view over all quality activities. From medical device manufacturers to biotech and therapeutics, Qualio partners with a diverse array of consultative and advisory organizations.
Are you interested in learning more about our partnership opportunities? Discover how easy it is to grow your business by leveraging our best-in-class eQMS.