Regulatory and Clinical Strategy under EU MDR or EU IVDR

General Background

Selecting an appropriate regulatory and/or clinical strategy for your medical device is a critical aspect of both the pre- and post-market device lifecycle. Whether the device is new to the market, planning significant changes or is undergoing initial conformity assessment under EU 2017/745 (EU MDR) or under EU 2017/746 (EU IVDR), an effective regulatory/clinical strategy can reduce both time and cost to market. Many manufactures may over or under design their strategy which can increase cost or submission risk.

To develop a regulatory strategy under the EU MDR or EU IVDR, a manufacturer should follow these general steps:

Support & Training

Contact AKRA TEAM for support, hands on implementation services and personalized training by experts with key competencies in the areas listed below.

Key points

  • An effective regulatory and clinical strategy is key to successful conformity assessment.

  • Regulatory and clinical strategies are important for all device lifecycle stages and are often over or under planned.

  • Regulatory and clinical strategy should be developed and introduced early in the project planning.

Our Services


AKRA TEAM provides training regarding both clinical and regulatory strategy. Our team of senior and clinical consultants have previous experience working in notified bodies and understand the expectations and requirements under EU MDR and EU IVDR. We can provide training suited to the relevant risk class and device characteristics.

Process and Templates Development

AKRA TEAM has proven procedure and document templates are available for all aspects of regulatory and clinical strategy including:

  • Strategy for regulatory compliance, MDR Art 10(9(a))/ /IVDR Art 10(8(a))
  • Clinical evaluation plan/Clinical development plan
  • Performance evaluation plan
  • Device specific regulatory plan

Gap Assessment

AKRA TEAM offers comprehensive gap assessments of regulatory/clinical strategies to highlight areas of risk or improvement prior to submission. AKRA TEAM will rank risks from high to low while offering mitigations to close any identified gaps.


AKRA TEAM has an experienced team of clinicians and regulatory experts available to develop a regulatory/clinical strategy based on the device type and risk-class. We offer custom tailored solutions or comprehensive solutions to addresses the needs of any manufacturer.

Interested in our services?

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