Seize the EU MDR Opportunity

Software Solutions for Medical Device Innovators

The European Union Medical Device Regulation (EU MDR) is the most significant revision to the EU regulatory system in over 20 years. Yet according to a 2018 Aberdeen survey, only 25% of life sciences companies are fully prepared to meet these regulations. The new regulation goes into effect in 2020 so time is of the essence. If you’re like most medical innovators – still searching for a workable solution – PTC can help.

Understand the Regulation

The EU published the new EU MDR replaces the MDD (Medical Device Directive) and went into force on May 25, 2017. Medical devices have three years to comply while in vitro diagnostics have five years.

As it relates to product data, the EU MDR has far-reaching implications. To stay in the EU market, your company must recertify all existing medical devices under the new regulation. But it will be harder to make clinical justifications based on device equivalence. After identifying all devices requiring recertification, you must collect all necessary product data. Other requirements include:

  • Each device will need a Unique Device Identifier (UDI) for the EU.
  • Device manufacturers must conduct post-market surveillance on their devices and regularly update technical documentation accordingly.
  • Product data submissions need to satisfy the requirements of the new European medical device database (Eudamed).
  • Manufacturers must implement both a risk and a quality management system.
  • Documentation must be clear and searchable, with labels and Instructions for Use (IFUs) available in local languages.

Because notified bodies will also be recertified, you may be dealing with a new notified body as well.

The Benefits of Compliance

With the right product data lifecycle processes, you gain newfound efficiencies that help streamline compliance. Early compliance gives you access to a potential $16.5 billion market. Plus, your engineering teams can focus on developing breakthrough medical products that improve lives and outcomes.

  • Ensure market access
  • Gain a competitive edge
  • Streamline innovation

Know the Risks: Consequences of Not Being Prepared

The EU wants to ensure medical devices are safe, high quality, meet stated expectations, and improve patient health. If your devices do not meet the EU MDR requirements, you can’t sell them in the European Union. Simply put, failure to comply takes business away from you and awards it to your rivals.

What happens if you miss the deadline for compliance? You can lose CE mark certification and be forced to withdraw devices from the EU market. Plus, you’ll experience delay introducing new devices. Such activities would hurt your revenue stream and reputation.

  • Withdrawal from EU market
  • Lost CE mark certification
  • Delays or inability to introduce new devices

Parts-Centric Design Control is Key to EU-MDR mastery

Whether ensuring existing devices remain compliant or new ones satisfy compliance requirements, your company must understand the expectations. The EU MDR is largely an extension of the existing regulation, but it requires far more product data.

At the core of the EU-MDR is the ability to manage, control and track continuously evolving product information. Fulfilling this mission is difficult in an environment characterized by continuous change. It’s especially challenging when the data comes in different versions and configurations and is distributed across multiple systems. The resulting errors and omissions can cause product delays, recalls, and add risk to your business. The last thing you want is to be outpaced by the competition because of disorganized, sluggish documentation workflows.

Because EU MDR requires far more data, it has significant implications for product teams. However, this transition is an excellent opportunity to restructure processes for efficiencies and more innovative, higher quality devices. Download this eBook from Tech-Clarity for expert guidance on preparing product data for regulatory submission.

 

How to Address Legacy Devices

The EU MDR does not allow companies to grandfather previously approved medical devices. While classifications will likely remain the same for the majority of devices, your company must still ensure compliance. At the very least, you might need to update clinical data, technical documentation and labeling. You should also review processes for quality assurance and risk management.

Follow the Lead of Life Sciences Innovators: Preparing for EU-MDR

Every medical device company wanting to do business in Europe must comply with EU MDR. According to Aberdeen, life sciences leaders use Product Lifecycle Management (PLM) to support processes for design control. PLM also serves as a hub for their unified quality and EU MDR compliance. Industry leaders also embrace PLM digitalization, gaining an edge by applying PLM broadly to key processes. Explore the advantages of Windchill Product Quality - PLM for Medical Innovators

PLM Digitalization Survey for Life Sciences

Tune in for Aberdeen and PTC insights drawn from the 2018 PLM Digitalization Survey for Life Sciences. Learn practical steps to effectively turn regulatory challenges into opportunities.

how leaders prepare for eu mdr

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