{"id":1473,"date":"2025-05-26T15:25:45","date_gmt":"2025-05-26T15:25:45","guid":{"rendered":"https:\/\/pharmilab.likealot.pt\/?page_id=1473"},"modified":"2025-07-10T14:25:53","modified_gmt":"2025-07-10T14:25:53","slug":"designacao-de-representacao-regulamentar-prrc","status":"publish","type":"page","link":"https:\/\/pharmilab.likealot.pt\/en\/designacao-de-representacao-regulamentar-prrc\/","title":{"rendered":"Appointment of the Person Responsible for Regulatory Compliance (PRRC)"},"content":{"rendered":"
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Appointment of the Person Responsible for Regulatory Compliance (PRRC)\u00a0<\/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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The designation of a Person Responsible for Regulatory Compliance (PRRC) is a mandatory requirement for all manufacturers and importers of medical devices and in vitro diagnostic devices under Regulation (EU) 2017\/745 (MDR) and Regulation (EU) 2017\/746 (IVDR).<\/p>

The PRRC is the individual appointed to ensure that all medical devices placed on the European Union market comply with the applicable legal and regulatory requirements, including conformity assessment, post-market surveillance, and product safety.<\/p>

We offer a comprehensive PRRC service, assuming this critical role on behalf of your company. We ensure that all MDR\/IVDR obligations are met efficiently and in full compliance with European legislation, allowing you to focus on your core business operations while we manage your regulatory responsibilities.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tNeed help or have any questions? Contact us.<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\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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Our services include <\/h2>\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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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tActing as the PRRC\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h4>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tActing as the PRRC, taking full responsibility for ensuring that your company complies with all legal and regulatory requirements under MDR\/IVDR\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\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

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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tOverseeing the conformity assessment process\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h4>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tOverseeing the conformity assessment process for your medical devices from development through to market placement\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\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

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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tManaging post-market surveillance\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h4>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tManaging post-market surveillance, including continuous monitoring of device safety and risk management\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\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

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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tDrafting and maintaining the required documentation\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h4>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tDrafting and maintaining the required documentation, such as vigilance plans, risk management files, and compliance reports\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\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

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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tProviding ongoing training and regulatory updates\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h4>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tProviding ongoing training and regulatory updates to ensure your company remains compliant with the latest requirements\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\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

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This service is essential for:<\/h2>\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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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tExternal PRRC\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h4>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tMicro and small companies can hire an external PRRC to ensure compliance with the European Medical Device Regulation (MDR). This option is advantageous because it eliminates the need to maintain an internal PRRC, thus reducing operational costs\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\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

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With our support, you can<\/h2>\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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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tPRRC obligation\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h4>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tFulfil the legal obligation to appoint a PRRC\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\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

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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tMDR\/IVDR requirements\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h4>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tEnsure full compliance with all MDR\/IVDR requirements throughout the entire device lifecycle\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\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

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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tMinimise the risk of non-compliance\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h4>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tMinimise the risk of non-compliance and safeguard both your company\u2019s reputation and user safety\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\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

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Through this service, we ensure that your organisation remains consistently aligned with regulatory requirements, relieving your internal team from the significant workload associated with the PRRC function.<\/h5>\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 Designa\u00e7\u00e3o de Representante Regulamentar (PRRC)\u00a0 A Designa\u00e7\u00e3o de uma Pessoa Respons\u00e1vel pela Conformidade Regulamentar (PRRC) \u00e9 uma exig\u00eancia obrigat\u00f3ria para todos os fabricantes e importadores de dispositivos m\u00e9dicos e de diagn\u00f3stico in vitro, de acordo com o Regulamento (UE) 2017\/745 (MDR) e o Regulamento (UE) 2017\/746 (IVDR). A PRRC \u00e9 a pessoa […]<\/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-1473","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/pages\/1473","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=1473"}],"version-history":[{"count":10,"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/pages\/1473\/revisions"}],"predecessor-version":[{"id":1740,"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/pages\/1473\/revisions\/1740"}],"wp:attachment":[{"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/media?parent=1473"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}