Medical Device Registration
EU Medical Device Registration: A Streamlined Path to Market Confidence
Expert Guidance Through Every Step of the MDR & IVDR Registration Process, Ensuring Speed, Compliance, and Commercial Success.
In the competitive European market, every day counts. Delays in medical device registration can impact your launch timeline, profitability, and strategic advantage. Aequum simplifies the entire process of registering medical devices in the EU, transforming a complex regulatory obligation into a clear, manageable pathway. From our strategic base in Malta, we ensure your innovative products meet all necessary requirements under the MDR and IVDR with precision and efficiency.
Our team is deeply versed in the nuances of the European regulatory landscape. We provide a hands-on, comprehensive approach that covers everything—from the initial classification of your product to final submissions and all necessary interactions with EU regulatory bodies. We act as your dedicated registration partner, ensuring your product is fully compliant and ready for market distribution in the shortest possible time.
Our Medical Device Registration Services Include:
Comprehensive Regulatory Pathway Assessment Before any documentation is prepared, we establish a clear and correct path forward. Our experts conduct a thorough assessment to determine your device's precise classification under the MDR or IVDR. This foundational step defines the specific conformity assessment route required, preventing costly missteps and building a solid strategy for a successful submission.
Preparation and Submission of Technical Documentation We manage the meticulous process of compiling, reviewing, and structuring the technical documentation required for your submission. Our team ensures that every element is robust, compliant, and presented professionally to meet the exacting standards of notified bodies and competent authorities, minimizing the risk of queries and delays.
Conformity Assessments and CE Marking Guidance Achieving the CE mark is the ultimate goal of the registration process, signifying your product's compliance and granting it access to the EU market. We guide you through the entire conformity assessment procedure, liaising with notified bodies and ensuring all legal and technical requirements are met to secure CE marking for your device.
Post-Market Surveillance (PMS) System Setup Registration is not the final step; it is the beginning of your product's lifecycle in the market. We assist in establishing the mandatory Post-Market Surveillance systems required by the regulations. This ensures you can maintain compliance, monitor your device's performance, and fulfill all your legal obligations long after launch.
Partner with Aequum to expedite your medical device registration with confidence. We streamline the complexities so you can focus on a successful European market launch.