What is a Regulatory Strategy?

A regulatory strategy is a comprehensive action plan covering every stage of a medical device’s lifecycle—from concept and design to certification and commercialization. Its primary goal is to ensure compliance with MDR 2017/745 or IVDR 2017/746 and minimize delays due to incorrect qualification or documentation. The strategy must also account for the responsibilities of the Person Responsible for Regulatory Compliance (PRRC), who ensures ongoing fulfillment of formal requirements and compliance oversight in line with Article 15 of MDR/IVDR.

Qualification and Classification of a Medical Device

Accurately defining the intended use and risk class of the device determines the subsequent compliance path. Proper classification of the medical device dictates the required conformity assessment procedure and scope of technical documentation. Classification errors, especially for Class D IVDs, may result in rejection by the notified body, as outlined in MDCG 2022-5.

The regulatory strategy should be based on the current legal framework, including MDR 2017/745, IVDR, ISO 13485, ISO 14971, and MDCG guidance, which further define quality, safety, and clinical compliance requirements. It is also crucial to consider UDI labeling and registration rules in the context of device traceability.

Conformity Assessment Procedure

The selection of the appropriate conformity assessment procedure depends on the device classification. Higher-risk devices require the involvement of a notified body, which evaluates the documentation, processes, and device effectiveness according to Annexes IX–XI of MDR or relevant IVDR sections. For Class D IVDs, EU reference labs may be involved early in the process and must be considered in the strategy.

General Safety and Performance Requirements (GSPR)

All devices must meet the General Safety and Performance Requirements (GSPR) listed in Annex I of MDR. These requirements must be assessed individually and documented in the technical file for each product.

Risk Management

The strategy should include a risk management process aligned with ISO 14971, integrated with functional analysis, design, validation, and lifecycle updates. Inconsistent risk assessment is a common reason for rejection by notified bodies. Integrating the risk register with PMS and PMCF documentation ensures transparency and continuity in analysis.

Preclinical Evaluation

During development, laboratory tests should confirm safety and performance. Preclinical evaluation includes biocompatibility testing, analysis of mechanical, chemical, and microbiological properties, and validation of manufacturing methods.

Clinical Development Strategy

For Class IIb and III MDR devices or Class C and D IVDR devices, clinical investigations may be necessary. Alternatively, clinical strategy may rely on literature analysis, PMS/PMCF data, or post-market observation. The approach should align with clinical investigation planning requirements. For IVDs, a Performance Evaluation Plan is essential; for implantable devices, a consistent PMCF plan is required.

Technical Documentation

Technical documentation forms the basis for demonstrating compliance with MDR or IVDR. It must support both design and clinical aspects and be ready for submission to authorities at any time during the product lifecycle.

Documentation should include at least: product description and intended use, design and development plan, risk analysis, and GSPR conformity assessment. For higher-class devices, clinical data (or performance data for IVDs), production documentation, PMS/PMCF strategy, UDI system, and change control procedures are also required.

The documentation must align with the quality system and account for regulatory changes, such as Regulation 2025/1021 and updates to MDCG guidance. Mismatches between documentation scope and device risk class or conformity route often result in formal rejection. Ensure consistency with the QMS structure and CAPA procedures.

Quality Management System (QMS)

Implementing a QMS is mandatory for MDR/IVDR-compliant manufacturers. It should be synchronized with the regulatory strategy and include design control, CAPA management, documentation oversight, and audit readiness.

Certification and Commercialization Planning

An effective strategy includes a timeline for UDI registration, CE marking, labeling, notified body selection, and clinical data readiness. It should also define EUDAMED submission plans and deadlines for individual modules. Delays in any of these areas can result in market launch risks.

2025 Regulatory Changes – Mandatory Strategy Updates

Regulation 2025/1021 introduced several key changes:

  • Mandatory registration of device data in EUDAMED for functional modules,
  • Requirement to report anticipated supply disruptions six months in advance,
  • Conditional extension of IVDR transitional periods, based on QMS implementation, notified body application, and signed certification agreement.

Strategies that fail to account for 2025 changes may lead to loss of EU market access after 2027.

Common Mistakes in Regulatory Strategy Development

  • Lack of strategy updates during the product lifecycle,
  • Incorrect classification and inappropriate conformity route,
  • Missing clinical data strategy or PMCF plan,
  • Delayed notified body engagement,
  • Disconnection between QMS and regulatory planning.

Absence of PRRC involvement and failure to align with updated MDCG guidance increases the risk of non-compliance and certification delays. A regulatory strategy is not a one-time document—it is a compliance risk management tool and key to market success.

How Pure Clinical supports manufacturers in regulatory strategy development

Pure Clinical provides support in:

  • Developing full regulatory strategies compliant with MDR/IVDR,
  • Selecting conformity procedures, risk assessments, and GSPR fulfillment,
  • Auditing technical documentation and representing clients before notified bodies,
  • Creating PMCF plans and IVD performance evaluation plans in line with MDCG 2020-7 and 2022-2,
  • Monitoring legislative updates and revising strategies per Regulation 2025/1021.

With up-to-date knowledge and experience, Pure Clinical helps shorten implementation timelines and reduce formal regulatory risks.

FAQ

Is a regulatory strategy subject to approval by the Notified Body?

No, Notified Bodies do not formally approve the regulatory strategy, but they assess its practical implementation through the review of technical documentation, GSPR compliance, and clinical justification. The strategy should support and validate the conformity assessment pathway.

How frequently should a regulatory strategy be updated?

It should be updated at least annually and after any major events, such as product redesigns, changes in classification, updated MDCG guidance, or modifications recorded in EUDAMED. A regulatory strategy is a living part of the QMS.

Which components of regulatory strategy are most commonly overlooked by manufacturers?

Common gaps include missing PMS planning, lack of integration with commercialization timelines, absence of PMCF data strategy, and failure to include a structured change management plan.

Can regulatory strategy be requested by an investor or strategic partner?

Absolutely – in high-risk device projects (Class III or Class D IVD), regulatory strategy is often a prerequisite in due diligence processes. It influences risk perception, project valuation, and strategic partnerships, especially in OEM or licensing agreements.