Regulatory strategy: A customized compliance plan for medical devices

Lukasz Kilianek

by Lukasz Kilianek

A medical device manufacturer's regulatory strategy is a detailed plan outlining how a company will navigate legal and regulatory requirements to market its products while ensuring compliance with all relevant regulations and standards. It entails taking a systematic approach to guarantee the medical devices' efficacy, safety, and quality and securing prompt market access.

The very brief mention in the European regulations (MDR 2017/745 Article 10.9 and IVDR 2017/746 Article 10.8) of the conformity assessment path and procedures for the management of modifications to medical devices, covered by the implemented QMS, provides a detailed definition of the document's content and structure. Other markets, such as the US, UK, CH, and ROW are governed by specific local regulations, however, some similarities can be found. Awareness is the key. 

The key to market access: Understanding your medical device's purpose and classifications

Everything begins with the intended purpose of the medical equipment, as it allows for the correct classification of the product as a medical device. Documentation proving compliance with the definition of a medical device must be included in the Regulatory Strategy. The next element of this document is the medical device classification records. The class of the device determines the possible conformity assessment path of the device. The description selected is another required element of the Strategy. The entity, whether designing the device for the manufacturer or the manufacturer itself, must identify the necessary regulatory requirements and applicable standards to demonstrate the device's General Safety and Performance. Additionally, a change management method must be provided.

Regulatory strategy

Based on the chosen conformity assessment path, the manufacturer must cover the Quality Management System in accordance with regulatory requirements as described in the Regulatory Strategy:

  • Approach to risk management,
  • Product supply chain management,
  • Approach to post-market surveillance and vigilance
  • Collection of clinical evidence,
  • Communication with competent authorities,
  • Requirements related to the technical documentation of the device.

The regulatory strategy not only increases awareness of necessary actions but also serves as a foundation for project evaluations and enhancing their value to investors. For investors and organizations providing seed funding or grants, the Strategy acts as a verification tool to assess project feasibility. A well-articulated regulatory strategy is crucial for the successful Design and Development process of a medical device.

Star's unique offering: The regulatory workshop for comprehensive medical device documentation

Star introduces a unique offering to this subject: a Regulatory Workshop. This workshop captures information from your organization and prepares it as inputs for product life cycle documentation, including:

  • Definition of intended purpose,
  • Inputs to product requirements,
  • Regulatory strategy to market the device (qualification, classification, safety classification, UDI, harmonized standards, path to market). 

This foundational aspect of the process is vital, and the outputs of this workshop are utilized as inputs for further Product and Software Development stages. 

Reach out to us to learn more about the workshop and sign up through the contact form if you need help with defining a regulatory strategy.

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Navigating medical device regulations R5dkbapm
Lukasz Kilianek
Quality and Regulatory Affairs Manager at Star

Lukasz is a seasoned professional with over 20 years of experience in the medical devices industry. Specializing in business and product development, device validation, regulatory affairs, and quality assurance, Lukasz is a certified lead auditor in ISO 13485 and a member of TEAM-PRRC. With his wealth of experience and expertise, Lukasz Kilianek continues to make significant contributions to the medical devices industry, ensuring the delivery of safe and effective products that improve patient outcomes worldwide.

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