Medical Product Companies in 2025: Still Holding on to the MDD in the EU and UK

The transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) in the European Union (EU) has been a pressing topic for medical product companies since its introduction. With the MDR officially replacing the MDD in May 2021, manufacturers were expected to comply with the stricter regulatory framework designed to enhance patient safety and product oversight. However, as we move through 2025, some companies continue to navigate the complexities of maintaining MDD compliance, both in the EU and the UK, despite the shift towards MDR.

Why Are Some Companies Still Using MDD?

While the MDR is fully in force, various factors have led some medical product companies to remain under the legacy MDD framework:

Extended Transition Periods

The EU introduced transition provisions that allow certain MDD-certified products to remain on the market until 2027 or 2028, provided they meet specific conditions. These grace periods offer companies additional time to obtain MDR certification.

Many businesses are leveraging these extended deadlines to delay costly and complex compliance processes.

Why Are Some Companies Still Using MDD?

While the MDR is fully in force, various factors have led some medical product companies to remain under the legacy MDD framework:

Extended Transition Periods

The EU introduced transition provisions that allow certain MDD-certified products to remain on the market until 2027 or 2028, provided they meet specific conditions. These grace periods offer companies additional time to obtain MDR certification.

Many businesses are leveraging these extended deadlines to delay costly and complex compliance processes.

Notified Body Bottlenecks

The MDR introduced more stringent requirements for Notified Bodies, significantly reducing the number of designated bodies available to conduct certifications.

The limited capacity of Notified Bodies has created a backlog, leaving many companies unable to complete their MDR transition promptly.

Regulatory Uncertainty and Cost Concerns

The MDR demands more robust clinical data, post-market surveillance, and risk management, adding significant compliance costs.

Some smaller and medium-sized enterprises (SMEs) struggle with the financial and resource-intensive requirements of MDR compliance, making them hesitant to transition until absolutely necessary.

UK Market Considerations

The UK, having exited the EU, follows its own regulatory pathway under the UK Medical Device Regulations 2002 (as amended post-Brexit). Although similar to the MDD, the UK has introduced an extended timeline for its new regulatory framework.

Some companies selling in the UK are still operating under MDD certificates, awaiting clearer guidance from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) before shifting to compliance with future UK-specific rules.

Notified Body Bottlenecks

The MDR introduced more stringent requirements for Notified Bodies, significantly reducing the number of designated bodies available to conduct certifications.

The limited capacity of Notified Bodies has created a backlog, leaving many companies unable to complete their MDR transition promptly.

Regulatory Uncertainty and Cost Concerns

The MDR demands more robust clinical data, post-market surveillance, and risk management, adding significant compliance costs.

Some smaller and medium-sized enterprises (SMEs) struggle with the financial and resource-intensive requirements of MDR compliance, making them hesitant to transition until absolutely necessary.

UK Market Considerations

The UK, having exited the EU, follows its own regulatory pathway under the UK Medical Device Regulations 2002 (as amended post-Brexit). Although similar to the MDD, the UK has introduced an extended timeline for its new regulatory framework.

Some companies selling in the UK are still operating under MDD certificates, awaiting clearer guidance from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) before shifting to compliance with future UK-specific rules.

The Risks of Sticking with the MDD

Despite these justifications, continuing to rely on the MDD poses significant risks for companies:

Market Access Limitations: As MDR certification becomes the standard, MDD-certified products may face increasing market restrictions.

Regulatory Scrutiny: Authorities and notified bodies are closely monitoring compliance, and failure to meet transition requirements could result in penalties or market withdrawals.

Competitive Disadvantage: Companies that have already transitioned to MDR may gain a competitive edge with more robust clinical validation and broader market acceptance.

The Risks of Sticking with the MDD

Despite these justifications, continuing to rely on the MDD poses significant risks for companies:

Market Access Limitations: As MDR certification becomes the standard, MDD-certified products may face increasing market restrictions.

Regulatory Scrutiny: Authorities and notified bodies are closely monitoring compliance, and failure to meet transition requirements could result in penalties or market withdrawals.

Competitive Disadvantage: Companies that have already transitioned to MDR may gain a competitive edge with more robust clinical validation and broader market acceptance.

What’s Next for Companies Holding on to MDD?

As we progress through 2025, medical product companies still using the MDD must carefully assess their transition plans. Organizations should:

Engage with Notified Bodies Early: Given the backlog, securing a Notified Body slot as soon as possible is critical.

Strengthen Clinical and Post-Market Data: MDR places a strong emphasis on clinical evidence and ongoing product monitoring, so companies should proactively gather the necessary data.

Monitor UK Regulatory Developments: With potential divergence from the EU MDR, businesses selling in the UK should stay informed on upcoming MHRA requirements.

Consider Strategic Portfolio Adjustments: Some companies may need to retire legacy products that cannot meet MDR standards or invest in redesign efforts to ensure compliance.

What’s Next for Companies Holding on to MDD?

As we progress through 2025, medical product companies still using the MDD must carefully assess their transition plans. Organizations should:

Engage with Notified Bodies Early: Given the backlog, securing a Notified Body slot as soon as possible is critical.

Strengthen Clinical and Post-Market Data: MDR places a strong emphasis on clinical evidence and ongoing product monitoring, so companies should proactively gather the necessary data.

Monitor UK Regulatory Developments: With potential divergence from the EU MDR, businesses selling in the UK should stay informed on upcoming MHRA requirements.

Consider Strategic Portfolio Adjustments: Some companies may need to retire legacy products that cannot meet MDR standards or invest in redesign efforts to ensure compliance.

How RQMIS Can Help

Navigating the transition from MDD to MDR can be challenging, but RQMIS is here to help. With a team of experts based in the US, UK, and EU, we provide comprehensive regulatory, clinical, and quality consulting services tailored to the needs of medical device manufacturers. Our expertise includes:

Regulatory Strategy & Compliance: We assist companies in developing efficient MDR transition plans, ensuring compliance while minimizing disruption to market access.

Notified Body & MHRA Liaison: Our team facilitates interactions with Notified Bodies and regulatory authorities to streamline certification and approvals.

Clinical Data & Post-Market Surveillance: We help companies generate, analyze, and present the clinical evidence required under MDR, as well as establish robust post-market surveillance systems.

Training & Support: RQMIS offers tailored training programs to educate teams on MDR requirements and best practices for compliance.

Whether you are still operating under MDD or in the process of transitioning to MDR, RQMIS provides the expertise and support needed to navigate the evolving regulatory landscape efficiently and effectively. Contact us today to discuss how we can assist your company in achieving compliance and maintaining market success.

How RQMIS Can Help

Navigating the transition from MDD to MDR can be challenging, but RQMIS is here to help. With a team of experts based in the US, UK, and EU, we provide comprehensive regulatory, clinical, and quality consulting services tailored to the needs of medical device manufacturers. Our expertise includes:

Regulatory Strategy & Compliance: We assist companies in developing efficient MDR transition plans, ensuring compliance while minimizing disruption to market access.

Notified Body & MHRA Liaison: Our team facilitates interactions with Notified Bodies and regulatory authorities to streamline certification and approvals.

Clinical Data & Post-Market Surveillance: We help companies generate, analyze, and present the clinical evidence required under MDR, as well as establish robust post-market surveillance systems.

Training & Support: RQMIS offers tailored training programs to educate teams on MDR requirements and best practices for compliance.

Whether you are still operating under MDD or in the process of transitioning to MDR, RQMIS provides the expertise and support needed to navigate the evolving regulatory landscape efficiently and effectively. Contact us today to discuss how we can assist your company in achieving compliance and maintaining market success.

Conclusion

The transition from MDD to MDR remains a challenging process for many medical product companies. While regulatory extensions and market factors allow some firms to maintain MDD compliance in 2025, the inevitability of MDR certification is clear. Companies that proactively address the transition will be better positioned for long-term success, ensuring compliance, market stability, and continued patient safety.

For medical product manufacturers, the message is clear: the time to act is now. Navigating the regulatory landscape efficiently will define which companies thrive in the evolving EU and UK medical product markets.

Conclusion

The transition from MDD to MDR remains a challenging process for many medical product companies. While regulatory extensions and market factors allow some firms to maintain MDD compliance in 2025, the inevitability of MDR certification is clear. Companies that proactively address the transition will be better positioned for long-term success, ensuring compliance, market stability, and continued patient safety.

For medical product manufacturers, the message is clear: the time to act is now. Navigating the regulatory landscape efficiently will define which companies thrive in the evolving EU and UK medical product markets.