Services
Global Markets
European Union – CE Marking
The Medical Devices Regulation (MDR), Regulation (EU) 2017/745 is applicable since 26 May 2021, after a 1-year postponement, due to the COVID-19 pandemic, which has led to several adjustments within organizations.
The regulatory support unit provides assistance in the MDR implementation processes, and in the transition processes from Medical Device Directive (MDD) 93/42/EEC, or Active Implantable Medical Device (AIMD) Directive 90/385/EEC, to the MDR, in order to ensure compliance with MDR requirements.
In this sense, our team provides support to manufacturers, distributors, importers and authorized representatives with services including revision of existing technical data and MDR gap analysis and the development of a MDR implementation plan or a MDD to MDR transition plan. The regulatory unit also assists in the classification of medical devices as per Annex VIII of the MDR (classes I, Is, Im, Ir, IIa, IIb, III), and in the identification of applicable standards and guidance documents to support the organizations in preparing or reviewing all the Technical Documentation, under Annex II and Annex III of MDR. Our team of experts also assists in the implementation or improvement of the Quality Management System (QMS).
United States of America – FDA Process
The regulatory support unit can help companies access the USA market through the FDA, a service that begins with an assessment of the regulatory pathway. We help with DM classification (classes I, II and III), as well as identifying applicable standards and guidance documents.
Our experts also provide assistance in responding to requests for clarification from the FDA. We can also help with the processes of listing the MD and registering the company with the FDA, as well as obtaining compliance with post-marketing requirements.
In particular, but not exclusively, we can help your company with the following processes with the FDA:
The FDA has a programme called Q-submission through which manufacturers can submit a request for clarification to the FDA in order to clarify potential doubts before the regulatory process is finalised. Under the Q-submission programme, the manufacturer communicates with the FDA, free of charge, requesting feedback on key issues related to the development of the device or the preparation of submissions.
At the regulatory support unit we can assist in the Q-submission drafting and submission process to ensure that the review process is more efficient and that the applicable requirements are satisfied.
Most class II DMs are placed on the US market through the 510(k) process. This process is a pre-market submission made to the FDA to demonstrate that the DM to be marketed is substantially equivalent to a legally marketed device (predicate device).
The regulatory support unit can collaborate throughout the 510(k) process, starting with the identification of the most appropriate predicate(s) for each device.
The De Novo FDA process is a procedure through which innovative DMs (classes I and II), which do not have an appropriate product code or predicate device, but whose general or special controls provide assurance of safety and efficacy for their intended use, can be evaluated by the FDA for marketing authorization.
The regulatory support unit can help DM manufacturers throughout the de novo process, starting with demonstrating the safety and efficacy of the device.
This is a use authorization process granted by the FDA during emergency situations, such as pandemics, when there are no suitable alternatives available. This allows DMs to be used temporarily without going through a full approval process, as long as the benefits outweigh the risks. Where applicable, the regulatory support unit also has the necessary expertise to assist in this process.
Premarket Approval (PMA) is a scientific and regulatory review process to assess the safety and performance of class III (high risk) medical devices. Given the risk associated with class III MDs, the PMA process is more rigorous, expensive and usually much longer than the 510(k) or De Novo processes.
The regulatory support unit we can help with the PMA process for high-risk medical devices. In this process, manufacturers must provide comprehensive clinical evidence to demonstrate the safety and efficacy of the device, and the FDA carries out a detailed review of this evidence before granting approval.
The Medical Device Regulatory unit we can also help you in the process of choosing a legal representative in the United States for your company.