The extension is here, but it’s not a safety net. Learn how to move fast, stay compliant, and protect your market share.

With Regulation (EU) 2023/607, the European Commission has introduced a critical extension to MDR deadlines for legacy devices certified under the previous MDD (Directive 93/42/EEC). It’s a valuable opportunity—but not an excuse to delay.

Many MedTech manufacturers are still figuring out the next steps, while others are at risk of losing their CE mark due to formal mistakes or slow execution. The extension isn’t automatic, doesn’t apply to all, and requires strict compliance with currently active conditions.

Who can really benefit from the MDR extension?

The new regulation outlines different deadlines based on device risk class:

  • For Class III and implantable devices, the CE mark is valid until December 31, 2027.
  • For all other legacy devices, the extension goes up to December 31, 2028.

However, this only applies if the manufacturer complies with all conditions laid out in Article 120(3c) of the MDR.

Complete application: the real make-or-break factor

The most crucial condition is having submitted a formal application to a Notified Body (NB) by May 26, 2024, with complete technical documentation and updated plans.

Late or incomplete submissions automatically disqualify the manufacturer from the MDR extension.

Waiting means losing ground

Some manufacturers are adopting a “wait-and-see” approach, counting on the extension to buy them more time. But those who act now gain a strategic edge—they can revise their technical files, plan targeted clinical studies, fix documentation gaps, and optimize the CER before the audit phase.

Proactive manufacturers are already:

  • Updating PMCF and PSUR in line with MDR guidance,
  • Launching observational studies to support compliance,
  • Verifying that QMS meets NB expectations.

How we can help you move faster and smarter

You don’t have to navigate the MDR maze alone – We4CR has everything it takes to help you move fast, stay compliant, and keep your CE mark secure. That means accelerating your path with expert NB interactions, optimized PMCF planning, and implemented clinical trials built for speed and compliance.

Our integrated approach includes:

  • Scientific support for technical documentation,
  • Full clinical study management,
  • Direct coordination with NBs and regulatory authorities.

Your CE Mark can’t wait

Still unsure how to build a complete application or where you stand with MDR? Let’s talk. We’ll help you assess your MDR status and avoid unnecessary delays – or worse, loss of CE certification.

The real race has started.

The deadlines may look distant, but in regulatory time, every month of delay can translate to months off the market.

Act now before your CE mark turns into a competitive liability.

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