Title: Navigating Regulatory Complexity: A Case Study of a US Cosmetics Company's Acquisition and EU Market Entry Strategy for a Medical Device Portfolio

Abstract:

This case study examines the regulatory challenges encountered by a US-based cosmetics company that acquired a medical device portfolio for cosmetic use from an overseas manufacturer. To facilitate the company's entry into the European Union (EU) market, Oakley Business Development was engaged to review and prepare a technical package suitable for EU product marketing. The regulatory approach for this product was notably intricate, as it fell under the classification of a medical device,, MDR 2017/745, despite not being a pharmaceutical. The study showcases the strategic measures undertaken to comply with EU regulations, encompassing Technical Document creation, Safety Study implementation, and CE registration.

Introduction:

Expanding into new markets presents unique regulatory hurdles for companies, particularly when dealing with products that straddle the boundaries of multiple regulatory frameworks. In this case, a US cosmetics company acquired a medical device portfolio designed for cosmetic use from an overseas manufacturer. However, marketing these products in the EU necessitated compliance with the complex regulatory framework for medical devices, (MDR 2017/745 ). This case study explores the company's partnership with Oakley Business Development to navigate the intricate regulatory landscape, emphasizing the challenges faced and the solutions devised to overcome them.

Objective:

The primary objective of this case study is to analyze the regulatory approach adopted by a US cosmetics company after acquiring a medical device portfolio. The focus is on preparing a technical package suitable for EU product marketing, adhering to the specific requirements for medical devices, and achieving successful CE registration. The study aims to shed light on the complexities and strategies involved in complying with EU regulations for a non-pharmaceutical medical device marketed as a cosmetic.

Methods:

The case study adopts a qualitative approach, relying on a comprehensive review of available documentation and interviews with key stakeholders involved in the acquisition and regulatory process. Primary data sources include company representatives, regulatory experts from Oakley Business Development, and relevant EU regulatory authorities. Secondary data sources include industry publications, regulatory guidelines, and EU directives and regulations related to medical devices and cosmetics.

Results:

1. Classification Challenges: The case study highlights the complexities of accurately classifying the acquired medical device portfolio under EU regulations. It discusses the considerations involved in differentiating between cosmetics and medical devices based on intended purpose, mode of action, and associated risks.

2. Technical Document Creation: The study explores the meticulous preparation of the technical package by Oakley Business Development, encompassing essential details such as design, intended use, performance data, and manufacturing processes. The importance of aligning the technical documentation with EU requirements for medical devices is emphasized.

3. Safety Study Implementation: The case study delves into the necessity of conducting a safety study to assess potential risks and ensure consumer safety. It outlines the processes undertaken, including collaboration with experts and compliance with EU regulations governing medical devices.

4. CE Registration Process: The case study provides insights into the CE registration process, highlighting the steps taken to achieve conformity with applicable conformity assessment procedures. It addresses the interactions with competent authorities and the importance of demonstrating compliance with MDR 2017/745.

Conclusion:

This case study highlights the regulatory challenges faced by a US cosmetics company that acquired a medical device portfolio for cosmetic use from an overseas manufacturer. Through the partnership with Oakley Business Development, the company successfully navigated the complex EU regulatory landscape by preparing a comprehensive technical package, conducting a safety study, and achieving CE registration. The study emphasizes the importance of meticulous compliance with EU regulations for medical devices marketed as cosmetics. It showcases the significance of engaging regulatory experts and employing strategic approaches to ensure successful market entry and expansion while maintaining compliance with stringent regulatory requirements.