{"id":1360,"date":"2025-05-26T11:48:23","date_gmt":"2025-05-26T11:48:23","guid":{"rendered":"https:\/\/pharmilab.likealot.pt\/?page_id=1360"},"modified":"2025-06-12T16:13:10","modified_gmt":"2025-06-12T16:13:10","slug":"dispositivos-medicos-faq","status":"publish","type":"page","link":"https:\/\/pharmilab.likealot.pt\/en\/dispositivos-medicos-faq\/","title":{"rendered":"Medical Devices - FAQ"},"content":{"rendered":"
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Medical Devices - FAQ<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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What is Technical Documentation? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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The technical documentation of a medical device is a set of documents that contains all the necessary information to demonstrate the safety, effectiveness, and compliance of the device with the requirements of European regulations (MDR 2017\/745 and IVDR 2017\/746).<\/p>

What is it for?<\/strong><\/p>

  • Demonstrates that the device meets the essential safety and performance requirements;<\/p><\/li>

  • It is mandatory for CE marking, allowing commercialization in the European Union;<\/p><\/li>

  • It must always be up to date and available to competent authorities.<\/p><\/li><\/ul>

    What should it include?<\/strong><\/p>

    The content may vary depending on the device\u2019s risk class but generally includes:<\/p>

    • Device description;<\/p><\/li>

    • Device classification (justification according to the MDR\/IVDR rules);<\/p><\/li>

    • Compliance with general safety and performance requirements;<\/p><\/li>

    • Product verification and validation;<\/p><\/li>

    • Benefit-risk analysis and risk management;<\/p><\/li>

    • Traceability and UDI;<\/p><\/li>

    • Instructions for use;\u00a0<\/p><\/li>

    • Manufacturing process;<\/p><\/li>

    • Post-market surveillance.<\/p><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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      What is CE Marking? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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      The CE Marking is a mandatory certification indicating that a product complies with the essential safety, health, and performance requirements established by the European Union.<\/p>

      What does it mean?<\/strong><\/p>

      • It allows the product to be marketed and used in the European Economic Area (EEA);<\/p><\/li>

      • Ensures that the product meets applicable European standards and regulations;<\/p><\/li>

      • For medical devices, CE Marking is mandatory and regulated by MDR 2017\/745 and IVDR 2017\/746.<\/p><\/li><\/ul>

        How to obtain CE Marking for Medical Devices?<\/strong><\/p>

        The process varies depending on the device's risk class and may include:<\/p>

        • Device Classification \u2013 Determining the class (I, IIa, IIb, or III) according to MDR.<\/p><\/li>

        • Technical File Preparation \u2013 Creating documentation that proves the device\u2019s compliance.<\/p><\/li>

        • Conformity Assessment \u2013 May involve a Notified Body (for higher-risk devices).<\/p><\/li>

        • Implementation of a Quality Management System \u2013 Example: ISO 13485.<\/p><\/li>

        • Testing and Clinical Trials \u2013 If necessary, to prove safety and efficacy.<\/p><\/li>

        • Declaration of Conformity for Class I (sterile or with a measuring function), IIa, IIb, and III devices, and Self-Declaration of Conformity for Class I devices (except those that are sterile or have a measuring function).<\/p><\/li>

        • CE Marking Placement \u2013 The product can be marketed in the European market.<\/p><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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          What is EUDAMED? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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          EUDAMED (European Database on Medical Devices) is a system created by the European Union to improve transparency and market surveillance of medical devices. It is part of the Medical Device Regulation (MDR 2017\/745) and the In Vitro Diagnostic Medical Device Regulation (IVDR 2017\/746).<\/p>

          The main functions of EUDAMED are:<\/strong><\/p>

          • Registering medical devices, manufacturers, authorized representatives, and importers;<\/p><\/li>

          • Ensuring traceability and compliance of devices on the market;<\/p><\/li>

          • Facilitating access to information for regulatory authorities and users;<\/p><\/li>

          • Improving patient safety through greater transparency.<\/p><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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            What is the Person Responsible for Regulatory Compliance (PRRC)? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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            The Person Responsible for Regulatory Compliance (PRRC) is a mandatory role for manufacturers and authorized representatives of medical devices in the European Union, according to the MDR 2017\/745 and IVDR 2017\/746 regulations.<\/p>

            What does the PRRC do?<\/strong><\/p>

            The PRRC is responsible for ensuring the manufacturer complies with regulatory requirements, including:<\/p>

            • Verifying device compliance before marketing;<\/p><\/li>

            • Maintaining technical documentation and the declaration of conformity;<\/p><\/li>

            • Managing post-market surveillance and reporting incidents;<\/p><\/li>

            • Ensuring manufacturing compliance with quality requirements.<\/p><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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              What is the European Authorized Representative (EC REP)? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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              The European Authorized Representative (EC REP) is a legally designated entity by medical device manufacturers outside the European Union (EU) to ensure regulatory compliance and act as a contact point with European authorities.<\/p>

              Responsibilities of the EC REP:<\/strong><\/p>

              • Ensuring regulatory compliance of the device before marketing in the EU;<\/p><\/li>

              • Maintaining technical documentation and the Declaration of Conformity available for authorities;<\/p><\/li>

              • Cooperating with national authorities during audits and investigations;<\/p><\/li>

              • Managing incident notifications and corrective actions related to post-market surveillance;<\/p><\/li>

              • Including the name and address on the device packaging for clear identification in the European market.<\/p><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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                What is the UDI? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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                The UDI (Unique Device Identification) is a mandatory global identification system for medical devices in the European Union, according to MDR 2017\/745 and IVDR 2017\/746 regulations. The goal is to improve traceability, safety, and transparency of medical devices on the market.<\/p>

                UDI Elements:<\/strong><\/p>

                The UDI consists of two main codes:<\/p>

                • UDI-DI (Device Identifier) \u2013 Identifies the specific model of the device and is fixed.<\/p><\/li>

                • UDI-PI (Production Identifier) \u2013 Contains variable information, such as batch number, serial number, and expiration date.<\/p><\/li><\/ul>

                  What is the importance of UDI?<\/strong><\/p>

                  • Facilitates traceability and recall management;<\/p><\/li>

                  • Enhances patient safety and reduces medical errors;<\/p><\/li>

                  • Helps combat counterfeiting and quality control.<\/p><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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                    What is a Notified Body (NB)? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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                    Notified Bodies (NB) are independent entities designated by the European Union to assess the compliance of medical devices and in vitro diagnostic medical devices (IVD), according to MDR 2017\/745 and IVDR 2017\/746 regulations.<\/p>

                    Who needs a Notified Body?<\/strong><\/p>

                    Submission to an NB is mandatory for higher-risk medical devices, i.e.:<\/p>

                    MDR 2017\/745:<\/strong><\/p>

                    \u2705 Class IIa<\/p>

                    \u2705 Class IIb<\/p>

                    \u2705 Class III<\/p>

                    \ud83d\udeab Class I (except for sterile devices, measuring devices, or reusable devices \u2013 in these cases, an NB is required).<\/p>

                    IVDR 2017\/746:<\/strong><\/p>

                    \u2705 Classes B, C, and D (mandatory)<\/p>

                    \ud83d\udeab Class A (except for sterile devices).<\/p>

                    What is the importance of an NB?<\/strong><\/p>

                    • Access to the EU market \u2013 Devices without NB certification (when required) cannot be marketed;<\/p><\/li>

                    • Safety and compliance \u2013 The process ensures devices meet safety and performance standards;<\/p><\/li>

                    • Credibility and international acceptance \u2013 Certifications issued by NBs are widely recognized in the industry.<\/p><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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                      Is certification of ISO 13485 and ISO 14971 mandatory? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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                      Certification is not mandatory, only implementation is required. However, certification greatly helps demonstrate compliance when evidence is requested.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

                      Voltar aos servi\u00e7os Dispositivos M\u00e9dicos – FAQ O que \u00e9 a Documenta\u00e7\u00e3o T\u00e9cnica? A documenta\u00e7\u00e3o t\u00e9cnica de um dispositivo m\u00e9dico \u00e9 um conjunto de documentos que cont\u00e9m todas as informa\u00e7\u00f5es necess\u00e1rias para demonstrar a seguran\u00e7a, efic\u00e1cia e conformidade do dispositivo com os requisitos dos regulamentos europeus (MDR 2017\/745 e IVDR 2017\/746). Para que serve? Demonstra […]<\/p>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-1360","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/pages\/1360","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/comments?post=1360"}],"version-history":[{"count":19,"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/pages\/1360\/revisions"}],"predecessor-version":[{"id":1548,"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/pages\/1360\/revisions\/1548"}],"wp:attachment":[{"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/media?parent=1360"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}