From MDD To MDR – How to turn your regulatory burden into a business opportunity
Before the introduction of the Medical Device Regulation (MDR), medical devices in the EU were certified under the Medical Device Directive (MDD). Many of these so-called ‘legacy devices’ still remain on the market under valid MDD certificates.
However, as the EU slowly shifts to the MDR, medical device companies must transition their products to the new regulations. The MDR is more stringent than its predecessor, so it’s easy to see it as an increased and unwelcome burden.
That’s why we’re dedicated to making the transition easier, helping you turn mandatory regulatory transition into a valuable business opportunity. Read on to learn more.
Transitioning legacy devices
The initial MDR compliance deadlines caused significant disruption to the industry – especially for companies with existing products on the market. This prompted the EU to make a series of regulatory amendments and extend the deadlines.
Safeguarding against shortages of critical medical devices, the EU chose to give manufacturers of certain high-risk products longer to comply with the MDR: high-risk Class III and Class IIb implantable devices by December 31, 2027, and lower-risk Class IIa and Class I reusable surgical instruments have until December 31, 2028.
While this extension provides much-needed breathing room, it does not mean device manufacturers can afford to delay their compliance efforts. In fact, some of the requirements already apply. For instance, you must have an MDR-compliant quality management system (QMS) in place and a contract with a Notified Body. Post-market surveillance, vigilance reporting, and product registration must also comply with MDR requirements.
The dangers of delaying transition
Despite deadline extensions, it’s important not to become complacent. There are concerns that some manufacturers are delaying MDR transition in the hope of further regulatory changes. However, this is a gamble that comes with a huge risk.
The longer a company waits to transition, the more difficult it will be to secure Notified Body capacity and complete the certification process before deadlines expire. In addition to these timing challenges, companies must also prepare for the significant differences between MDD and MDR certification.
The MDR has much stricter requirements than the MDD, adding to the regulatory burden. This results in higher compliance costs, more rigorous clinical evaluations, and additional complexity when compiling your technical dossier. Successfully navigating these requirements demands expert regulatory knowledge, which can be difficult to find.
If you do have the option to stick with MDD certification (for now) you also need to be mindful of the drawbacks:
- The MDD hinders innovation
Any substantial modification to an MDD-certified device requires full MDR certification. If you’re looking to make a major enhancement, improvement, or upgrade to an existing product, you will need to transition to the MDR sooner rather than later. - MDR compliance is essential for new products
While legacy devices can temporarily remain on the market with MDD certification, any new products must be MDR-certified. If you wish to expand your product portfolio or introduce significant technological advancements, MDR compliance is non-negotiable. - Notified Bodies are inundated with applications
It’s no secret that the Notified Bodies responsible for issuing certifications are overwhelmed with applications. This has led to significant delays in processing certifications. This backlog means that as a manufacturer, you must plan ahead to avoid future disruptions to product availability.
The benefits of MDR certification
Delaying the transition to the MDR (for eligible existing devices) is one possibility. But as we’ve seen, this comes with a stack of disadvantages. The alternative? Approach it another way: be MDR compliant sooner, and grab these benefits before your competitors do.
- Be the ‘gold standard’ in medical device quality
The MDR framework is widely seen as one of the most stringent medical device regulations in the world. Compliance demonstrates a company’s commitment to the highest safety and performance standards. As other countries adopt similar regulatory frameworks, MDR certification strengthens a company's global reputation. - Build trust with healthcare providers and patients
Trust is crucial in the medical device industry, and MDR certification provides a competitive advantage by demonstrating a commitment to quality. MDR compliance reassures medical professionals, healthcare institutions, and patients that a device has undergone rigorous safety and performance evaluations. - Unlock innovation (again)
Once a product is MDR-certified, you can implement significant changes and innovations (with the correct documentation). Unlike legacy devices under MDD, MDR-compliant devices can evolve with technological advancements and new market demands. Companies that transition early will gain a strategic advantage in adapting their products to the latest industry trends.
Turn compliance into a competitive edge
There are two ways to view MDR transition – an obstacle or an opportunity. Here’s how you can use it to your advantage:
- Strengthen your Quality Management System (QMS): Companies that invest in their QMS are better equipped to manage regulatory challenges and drive product improvements in the future. A robust, MDR-compliant, QMS streamlines compliance, reduces inefficiencies, and facilitates innovation.
- Embrace digital transformation: Many medical device companies integrating digital solutions to improve regulatory compliance can also improve their operational efficiency. Automated documentation management, AI-powered tools, and digital tracking systems help streamline MDR compliance and enhance overall productivity.
- Bring your product to market faster: If your Quality Assurance (QA) and Regulatory Affairs (RA) teams get involved early in the process, it gives you a head start on product safety and compliance. This helps eliminate any nasty surprises when you’re awaiting approval from your Notified Body.
- Unlock global market expansion: Companies that achieve MDR certification gain a competitive edge in global markets. Many countries recognize or align their regulations with the EU framework, making MDR-certified devices more attractive for international distribution.
The time to transition is now
The deadline may seem far away, but the demand for Notified Bodies and regulatory support will only increase as it approaches. Companies that act now will be better positioned to meet the challenges ahead and capitalize on the opportunities MDR presents.
Companies that fail to transition risk losing access to the EU market. While current stocks of MDD-certified devices can still be sold, once they run out, manufacturers will need MDR certification to continue selling their products. Previously, a sell-off date was in place, requiring unsold MDD-certified devices to be removed from the market by a specific deadline. However, this requirement was recently scrapped, allowing these devices to remain on the market until they reach the end of their shelf life.
Transitioning from the MDD to MDR is not just about regulatory compliance – it’s about future-proofing your business. Medical device companies that embrace the MDR early will gain a competitive advantage that EU approval brings:
- recognition of product safety and quality
- increased trust among healthcare professionals and patients
- the ability to innovate new products and features
The path to MDR compliance is challenging, but with careful planning, the right expertise, and a proactive approach, you can successfully navigate the transition. Investing in a strong QMS, leveraging digital tools, and engaging regulatory experts will ease the process and set the stage for long-term success.
If you need expert guidance on your transition, now is the time to start. Don’t wait – ensure your business is ready for the future of medical device regulation. Get in touch with one of our regulatory experts today.