Navigating Regulatory Pathways for Worldwide Market Entry

The journey to global market access is a challenging one for medical device manufacturers, whether you’re a start-up, an SME, or a multinational corporation.

The key to unlocking new opportunities and driving business growth for your medical devices lies in successfully navigating the complex medical device regulations.

At QAEC Limited, we specialise in demystifying regulatory requirements and streamlining the submission process for markets worldwide, including Canada (MDEL), the US (510(k)s), Australia, Japan, and the Middle East.

The complexities of preparing technical documentation for market entry under Medical Device Regulations can be challenging, making it difficult to streamline the review process and conformity assessment.

The requirements are already quite complex, and you also need to be ready for increased scrutiny of devices due to changes from directive to regulation under EU 2017/745 and IVDR 2017/746. Additionally, there is the uncertainty of the UK regulatory framework, which you may find daunting.

As regulatory experts, we frequently encounter recurring issues where technical documentation does not comply with relevant regulatory requirements. This has the potential to cause delays in market access, which can impact patient health and impede new technology innovation.

The IVDR clearly states the requirements for the intended use of an In Vitro Diagnostic, with section 1.1 of Annex II defining what information needs to be captured.

The MDR also captures information that needs to be considered, but not as extensively as the IVDR.

It is crucial to define the intended purpose and indications for use of your device, as a critical first step. This not only determines the classification of your device, which stipulates the regulatory pathway, but also defines aspects of your clinical evaluation plan. Having this understanding early in the development process will enable you to plan accordingly and ensure that you follow the correct regulatory classification and pathway.

Our expert services are designed to facilitate your medical device’s journey from concept to market, ensuring compliance every step of the way and supporting you with:

• Technical File Remediation, e.g., GSPRs and labelling
• Technical Documentation Compilation and Review
• Audit Support
• Regulatory Submission Process
• Technical File Management
• Line Extensions and Clinical Study Reviews
• Standard Operating Procedure Development
• Project Management and Validation