Develop. Validate. Comply.
IPN has a multidisciplinary team capable of providing complementary expertise through R&D, innovation, entrepreneurship and technology transfer activities in the fields of Digital Transformation and Healthcare, as well as in the development, validation, evaluation and regulatory support of solutions for telemedicine and tele-rehabilitation.
With experts in Global Markets, (FDA, CE marking), Cybersecurity, Artificial Intelligence and Robotics, we are able to provide a suitable solution for every type of product – Medical Devices and Software as Medical Devices
European Union – CE marking
Regulation (EU) 2017/745 on medical devices (MDR) has been in force since 26 May 2021, following a one-year postponement due to the COVID-19 pandemic, which has led to a number of changes within organisations.
The regulatory support unit provides assistance with the implementation of the MDR and with the transition processes for Directive 93/42/EEC on medical devices and Directive 90/385/EEC on active implantable medical devices, in order to ensure compliance with the requirements of the MDR.
In this regard, our team provides support to manufacturers, distributors, importers and authorised representatives, offering services that include a review of existing technical documentation and a gap analysis, followed by a transition plan from the Medical Devices Directive to the MDR, or a plan for the full implementation of the MDR from the outset. The regulatory support unit assists with the classification of medical devices in accordance with Annex VIII of the MDR (classes I, Is, Im, Ir, IIa, IIb, III), and with the identification of applicable standards and guidance documents, as well as with the preparation or review of all technical documentation, in accordance with Annex II and Annex III of the MDR. Our team of experts also provides assistance with the implementation or adaptation of the Quality Management System (QMS) for medical devices.
United States of America – FDA
The regulatory support unit can assist companies in gaining access to the US market through the FDA, a service that begins with an assessment of the regulatory pathway. We assist with the classification of medical devices (Classes I, II and III), as well as with identifying applicable standards and guidance documents.
Our specialists also provide assistance in responding to requests for clarification from the FDA. We can also assist with the processes of medical device listing and company registration with the FDA, as well as in ensuring compliance with post-market requirements.
In particular, though not exclusively, we can assist your company with the following procedures with the FDA:
The FDA has a programme known as Q-submission, through which manufacturers can submit a request for clarification to the FDA in order to resolve any potential concerns before the regulatory process is finalised. Under the Q-submission programme, the manufacturer communicates with the FDA, at no additional cost, to seek feedback on key issues relating to the development of the device or the preparation of submissions.
At the Regulatory Support Unit, we can assist with the preparation and submission of the Q-submission, to ensure that the review process runs more efficiently and that all applicable requirements are met.
Most Class II medical devices are placed on the US market via the 510(k) process. This process involves a pre-market submission to the FDA to demonstrate that the medical device to be marketed is substantially equivalent to a legally marketed device (predicate device).
At the Regulatory Support Unit, we can assist with the entire 510(k) process, starting with the identification of the most appropriate predicate device(s) for each device.
The process The New The FDA’s predicate device designation is a procedure whereby innovative medical devices (Class I and II) that do not have a suitable product or predicate device code, but whose general or special controls provide assurance of safety and effectiveness for the intended use, may be evaluated by the FDA for marketing authorisation.
At the Regulatory Support Unit, we can assist medical device manufacturers throughout the De Novo process, starting with demonstrating the safety and efficacy of the device.
This is an authorisation process granted by the FDA during emergency situations, such as pandemics, when no suitable alternatives are available. It allows medical devices to be used temporarily without undergoing a full approval process, provided that the benefits outweigh the risks. Where applicable, the Regulatory Support Unit also has the necessary expertise to assist with this process.
Premarket Approval (PMA) is a scientific and regulatory review process designed to assess the safety and performance of Class III (high-risk) medical devices. Given the risks associated with Class III medical devices, the PMA process is more rigorous, costly and typically much more time-consuming than the 510(k) or The New.
At the Regulatory Support Unit, we can assist with the PMA process for high-risk medical devices. Under this process, manufacturers must provide comprehensive clinical evidence to demonstrate the safety and effectiveness of the device, and the FDA conducts a detailed review of this evidence before granting approval.
At the Regulatory Support Unit, we can also assist you in selecting a legal representative in the United States for your company.
ISO 13485 is a quality management system standard specifically designed for manufacturers of medical devices and in vitro diagnostic medical devices. Compliance with ISO 13485 can help you meet regulatory requirements, manage risk and ensure the conformity of your product(s). By implementing a comprehensive QMS, you can ensure that your products meet the highest standards of quality and safety, and are effective for their intended use.
Furthermore, with the entry into force of the European Medical Devices Regulation (EU) 2017/745 (MDR) and the European In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), manufacturers of medical devices and in vitro diagnostic medical devices are now required to implement a QMS in accordance with Article 10 (MDR and IVDR), with ISO 13485 being the standard best suited to these requirements. Compliance with these regulations is mandatory for all manufacturers of medical devices and in vitro diagnostic medical devices wishing to place their products on the European Union market.
Our Regulatory Support Unit can assist your company in establishing and implementing a Quality Management System in accordance with ISO 13485, including conducting the initial audits.
Implementing ISO 13485 can be a challenging process, but it is essential for manufacturers of medical devices and in vitro diagnostic medical devices to ensure the safety and effectiveness of their products, as well as regulatory compliance. If you already have a QMS in place within your organisation, to ensure that it complies with the requirements of Article 10 of the MDR/IVDR and ISO 13485, it is advisable to follow these steps:
Our Regulatory Support Unit can assist your company in adapting its QMS to the requirements of ISO 13485 and associated regulatory requirements, including by conducting audits.
A gap analysis of the regulatory requirements for medical devices is designed to compare the manufacturer’s requirements with a relevant standard or regulation, depending on the markets in which the product is intended to be marketed. Our team can help you identify the applicable standards and regulations and assess your product’s requirements against the identified standards/regulations. By taking these gaps into account, our team can help you identify potential areas of risk so that you can set priorities and plan ahead. This means you do not have to spend unnecessary time, money and resources on avoidable compliance issues.
A cybersecurity gap analysis for a medical device is a process of assessing the cybersecurity status of the device and its associated software system to identify potential vulnerabilities in network security. Our team can help you implement the correct procedures to validate that your medical device and its software system are secure and compliant with relevant standards, best practices and regulations. With our comprehensive Gap Analysis services, we can identify potential security risks and develop strategies to mitigate them, reducing the risk of data breaches and other security incidents.
A gap analysis of the technical and regulatory requirements for medical devices may involve an assessment of the product at various stages, including planning, design, development, validation and maintenance. Our team can assist your company by conducting a Gap Analysis to identify the main gaps at every stage of the development process and provide tailored advice on the next steps on the path to market, specifically regarding the initial concept, product design, prototyping, device testing, design verification and validation, and the manufacture of medical devices.
A gap analysis of the technical and regulatory requirements for medical devices may involve an assessment of the product at various stages, including planning, design, development, validation and maintenance. Our team can assist your company by conducting a Gap Analysis to identify the main gaps at every stage of the development process and provide tailored advice on the next steps on the path to market, specifically regarding the initial concept, product design, prototyping, device testing, design verification and validation, and the manufacture of medical devices.
As part of its support for the certification of medical devices, the Pedro Nunes Institute offers services for the testing and validation of health technologies, taking into account the current regulatory framework. This expertise lies in supporting the conduct and reporting of pre-clinical trials, as well as in the design, implementation, conduct, monitoring and data processing of clinical trials for medical devices, in collaboration with partner clinical units – the Coimbra Local Health Unit (ULS), amongst other hospital institutions under the TEF-Health partnership.
Electromagnetic Compatibility (EMC) pre-compliance test (EN 55032:2015/A11:2020)
To ensure that the device is ready for the EMC radiated emission test (EN 55032:2015/A11:2020), the Pedro Nunes Institute offers pre-compliance EMC testing services to enable the rapid identification of the ‘dominant noise source’ and allow the design team to focus on a single component of the device. By quickly comparing potential faults with different options or minor design adjustments, the risk of the device failing the final EMC radiated emission test required for placing the device on the market can be reduced.
Formative usability testing (IEC 62366-1: 2015)
Formative usability testing is not intended to comprehensively assess the safety and performance of a device. These services focus on an iterative process where usability tests are conducted early and repeatedly during device development. The goal of this service is to identify and correct any usability issues before the device is finalized, which means:
Summative usability testing (IEC 62366-1:2015)
Summative usability testing involves evaluating the user interface with the intention of exploring its strengths and weaknesses. design Regarding the user interface and unforeseen usage errors, as per IEC 62366-1:2015: Medical devices – Part 1: Application of usability engineering to medical devices: the objective of usability testing is to identify approaches to make a product easier to use for its intended users. Usability testing focuses on the user's experience with the device, including the graphical user interface (GUI), providing valuable information on how users interact with the product and what improvements can be made to enhance their experience. The results of usability tests allow for product refinement to ensure the satisfaction of users' needs and expectations. Usability test results enable companies to ensure the development of a final product that is not only functional but also intuitive and enjoyable to use, leading to greater user satisfaction and loyalty. The service includes study design, support in defining the clinical team, support for clinical researchers in managing patient recruitment, research monitoring and data collection in accordance with good clinical practices, and study reporting.
Support in documenting clinical research.
Meeting the regulatory requirements for documentation related to the submission of clinical research studies to ethics committees and competent authorities (e.g., Annex XV of the RDM for clinical research studies in the European Union), our specialists are trained to support companies in preparing the documents through an integrated approach, which includes:
Clinical Research Management
The Instituto Pedro Nunes, in collaboration with Unidade Local de Saúde de Coimbra (ULS-C) and the partner clinical institutions within the platform TEF-Health, relies on the expertise of highly qualified healthcare professionals, tier I-II*, for the validation process of new health technologies with regard to their suitability and clinical receptiveness, through a systematized process composed of 3 stages,
* Tier I – High: healthcare professional with international recognition (publications/communications) and >10 years of experience in the respective clinical (sub)specialty; Tier II – Medium: healthcare professional with national recognition (publications/communications) and 5-10 years of experience in the respective clinical (sub)specialty; Level III – Low: healthcare professional recognized locally and < 5 years of experience in the respective clinical (sub)specialty.
The medical device vigilance system is designed to collect information on post-market incidents or adverse events relating to medical devices and, where appropriate, to disseminate or make public such information in order to prevent the recurrence of adverse events.
This means that medical device manufacturers must have a specific system in place for managing vigilance activities. Manufacturers or their authorised European representatives are required to notify the competent authority in the event of any incident involving their devices.
The Regulatory Support Unit helps manufacturers to implement medical device vigilance systems in compliance with all legal and regulatory requirements, and also supports incident reporting and incident investigation.
The placing of a medical device on the market is preceded by an assessment of residual risks related to quality, safety, and performance. However, this assessment should continue throughout the device's lifecycle, including the post-marketing period.
Post-market monitoring allows manufacturers to collect and analyze data on the effective use of medical devices.
Based on the results of this analysis, other actions may be necessary, such as:
Usability tests should be conducted by anyone who plays a role in operating the device, from patients to healthcare professionals and those responsible for maintaining the device.
Post-market monitoring activities are planned in the Post-Market Monitoring Plan and can be reactive or proactive.
Reactive activities include:
In the event of causality associated with the device, an investigation is carried out, and, if necessary, corrections and corrective actions are taken.
Proactive monitoring activities include:
Post-marketing monitoring data is compiled in the Post-Marketing Monitoring Report (for Class I medical devices) or the Periodic Safety Report (for Class IIa, IIb, and III medical devices).
The Regulatory Support Unit team can facilitate this process and prepare the Post-Marketing Monitoring Report or the Periodic Safety Report.
For each device, the manufacturer must confirm compliance with the relevant General Safety and Performance Requirements (GSPR) under normal conditions of the device's intended use, as well as an assessment of undesirable side effects and the acceptability of the benefit-risk ratio. This confirmation will be based on clinical data providing sufficient clinical evidence, including, where applicable, the relevant data mentioned in Annex III of the RDM. Clinical data are collected and compiled as part of a clinical evaluation, which follows a rigorous clinical plan. Clinical Evaluation Reports are required for all medical devices in Europe. The regulatory unit supports manufacturers by preparing clinical evaluation reports to demonstrate compliance with the GSPR, according to the intended use of the devices.
Medical devices or materials that come into contact with a patient are expected to perform their intended function without causing any adverse effects. For this reason, medical devices are typically subjected to biological assessment and biocompatibility testing to evaluate the interaction between a device and a patient's tissues, cells, or bodily fluids. The primary goal of biocompatibility assessment of a device is to protect the patient from potential biological hazards. Biological assessment is an ongoing process to identify specific biological hazards associated with devices, estimate and evaluate their risks, and monitor the effectiveness of controls.
The ISO 10993 series provides guidelines and requirements for manufacturers to adequately reduce biological risks to an acceptable benefit/risk level, including testing to confirm biocompatibility. Biological assessment of any medical material or device intended for human use must be part of a structured biological assessment plan within a risk management process, in accordance with ISO 14971.
Finally, all relevant evidence is summarized in a Biological Assessment Report (BAR), which provides a final conclusion and a statement on the biocompatibility and safety for the use of the device within its intended purpose in the intended patient population. The regulatory unit assists in collecting all data to compile the BAR, including defining the necessary tests and selecting appropriate laboratories. If applicable, our unit also provides assistance in preparing an equivalence-based BAR.
Registration of manufacturers, authorized representatives and importers
Registration of manufacturers, authorized representatives and importers: In accordance with Article 31 of Regulation 745/2017, economic operators must register with EUDAMED to obtain a Single Registration Number or “SRN” by submitting information through the appropriate database module.
What are economic operators?
According to the definitions in Regulation 745/2017, an "Economic Operator" is a manufacturer, authorized representative, importer, distributor or producer (or persons who sterilize) of systems or kits for interventions.
According to the European Commission, an actor is a natural or legal person (organization) with a specific role in the manufacture and marketing of devices and who must be registered with EUDAMED. Thus, each economic operator is a participant for the purposes of using EUDAMED.
The economic operator will obtain a unique SRN for each actor role. If the economic operator has multiple roles, separate registration applications are required to obtain a different and specific SRN for each actor role.
Manufacturer | MF |
Representative | AR |
Producer of the system and the set for interventions. | S/PPP |
Importer* | IM |
*Importers are companies that purchase medical devices directly from manufacturers outside the European Union.
Attention: Distributors should not register with EUDAMED. For them, the national regulations of each Member State apply.
How does the registration process work?
The information relating to each economic operator, as defined in Annex VI, Part A, Section 1 of the Regulations described above, is entered into EUDAMED and, once validated by the corresponding national competent authority, the economic operator receives a National Registration Number (NRN) following an email notification. The validation time depends on the Agent (where applicable) and the Competent Authority.
What information is needed for registration?
What is the importance of SRN?
The Regulatory Support Unit team can assist you with EUDAMED registration and help your company register its products.
IPN has a multidisciplinary team capable of providing complementary expertise through R&D, innovation, entrepreneurship and technology transfer activities in the fields of Digital Transformation and Healthcare, as well as in the development, validation, evaluation and regulatory support of solutions for telemedicine and tele-rehabilitation.
The Regulatory Support Unit team played a vital role in the early days of Ophiomics and the development of its QMS. This included meetings to review documentation, addressing the need for records that we had not previously considered mandatory, and providing comprehensive regulatory support regarding the instruction manual, packaging and labelling. Legislation is never clear, and having specialist support was and remains fundamental for Ophiomics, which is now certified to the ISO 13485 standard and already has an in vitro diagnostic medical device with CE IVD marking.
We are delighted to bear witness to the outstanding capabilities of the IPN’s Medical Devices Regulatory Unit, which provides a personalised service of exceptional quality. The team’s experience, professionalism and dedication have been fundamental to our organisation’s success.
Insparya provides services of the highest standard, and the IPN has provided the necessary support to help us meet this demanding commitment to quality.
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