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).
European In Vitro Medical Devices Regulation (IVDR), Regulation (EU) 2017/746 is applicable since 26 May 2022, repealing In Vitro Diagnostic Medical Device Directive (IVDD) 98/79/EC. Our team supports manufacturers, importers, distributors, and authorized representatives in the IVDR implementation processes, or in the IVDD to the IVDR transition processes, to ensure compliance with IVDR requirements.
The regulatory support unit services include revision of existing technical data, IVDR gap analysis, elaboration of an IVDR implementation plan (or an IVDD to IVDR transition plan), and identification of applicable standards and guidance documents. We also provide assistance in IVD classification as per Annex VIII of the IVDR (classes A, B, C, D). The regulatory support unit also supports on Technical Documentation drafting or review (under Annex II and Annex III of the IVDR) and Quality Management System (QMS) implementation or improvement.
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.
Brazil - ANVISA Process
Brazil represents the largest medical device and IVD market in Latin America, and our regulatory support unit can help companies that want to commercialize their medical devices or in vitro diagnostic medical devices on the Brazilian market.
As part of our services, we can help them in the following ways:
In order to operate in the Brazilian market, it is necessary to know and comply with the applicable regulations and standards. The process of regularizing medical devices (MDs) or in vitro diagnostic medical devices (IVDs) must be conducted in accordance with the guidelines contained in the applicable legislation.
The National Health Surveillance Agency (ANVISA) is the Brazilian organization responsible for regulating medical devices and IVDs.
The first step in the regulatory process is to determine the risk class of your MD or IVD, which can fall into one of four categories: Class I, Class II, Class III and Class IV.
Class I and II devices must follow the Notification route, while Class III and IV devices must follow the more complex Registration route, which requires analysis before approval.
The regulatory support unit can help with the classification of your device, as well as mapping the specific regulations applicable to your product. We also provide assistance in drafting or reviewing the technical dossier, filing and monitoring the process, as well as complying with requirements. In other words, we can help your company through all the stages of product regularization, always with transparency, in order to guarantee the quality of our services.
Good Manufacturing Practices (GMP) are a set of methods and controls used in the design, procurement, manufacture, packaging, labelling, storage, distribution, installation and technical assistance applicable to the manufacture of medical devices (MDs) and in vitro diagnostic medical devices (IVDs).
To comply with Brazil’s requirements, companies that want to sell Class I and II MDs and IVDs must fulfil the GMP requirements established by the National Health Surveillance Agency (ANVISA), but the agency will not issue a certificate. For Class III and IV DMs or IVDs, the company must submit a Good Manufacturing Practices Certificate (GMPC) along with the product registration.
The Good Manufacturing Practices Certificate is the document issued by ANVISA certifying that a given establishment complies with the procedures and practices established in specific Agency standards.
The regulatory support unit can help with the fulfilment of GMP requirements and, if applicable, assist in obtaining the respective certification, instructing the company in all the stages up to approval by the competent authority.
In Brazil, the National Telecommunications Agency (ANATEL) is the authority responsible for regulating the country’s telecommunications sector.
ANATEL homologation of products subject to compulsory certification (such as devices with Bluetooth or Wi-Fi connections) is a mandatory requirement for commercialization in Brazil.
Certification is performed prior to homologation, and consists of a set of tests and procedures that result in the issue of a Certificate of Technical Conformity.
After certification, homologation is carried out directly by ANATEL.
The Regulatory Support Unit can assist companies throughout the ANATEL homologation process for their product, always with transparency, in order to guarantee the quality of our services.
Some medical devices, by their nature, require compulsory certification by the National Institute of Metrology, Quality and Technology (INMETRO), which grants the Certificate of Conformity itself or through third parties, based on reports issued by accredited testing laboratories. INMETRO certification is often required for electromedical devices subject to IEC 60601, as well as other medical devices such as hypodermic needles, surgical gloves, blood bags, etc.
For medical device companies located outside of Brazil, the test results must be validated by an INMETRO certifier, and they usually accept electrical safety tests carried out by foreign testing organizations, if carried out by laboratories certified by the International Laboratory Accreditation Cooperation (ILAC).
The Regulatory Support Unit can assist your company in obtaining certification from INMETRO. This can include everything from selecting a Product Certification Body (OCP), assessing the test plan, selecting an accredited laboratory, preparing or adapting the required documentation (manuals, labelling, packaging, etc.), critically analyzing test/audit results, structuring action plans for non-conformities or any other type of need that may arise.
Other territories:
Canada, Latin America and South Korea