Medical Devices
regulatory
Weprovidetechnicalandregulatorysupportformedicaldevicesandinvitrodiagnosticdevices,ensuringcompliancewiththeMDRandIVDR.
Pharmilabisahighlyexperiencedproviderofcompletesolutionsforthedevelopment,regulation,andmarketplacementofcosmeticproducts,guaranteeinglegalcomplianceandqualityateverystep.
Weprovidetechnicalandregulatorysupportformedicaldevicesandinvitrodiagnosticdevices,ensuringcompliancewiththeMDRandIVDR.
Fromclassification,documentation,andCEmarkingtoEUDAMEDsubmissionandISO13485implementation,weoffercomprehensivesolutionstailoredtoeachclient’sneeds.
Pharmilabisahighlyexperiencedproviderofcompletesolutionsforthedevelopment,regulation,andmarketplacementofcosmeticproducts,guaranteeinglegalcomplianceandqualityateverystep.
Fromclassification,documentation,andCEmarkingtoEUDAMEDsubmissionandISO13485implementation,weoffercomprehensivesolutionstailoredtoeachclient’sneeds.
Medical Device Classification
Correct classification is the foundation of regulatory compliance for medical devices in the EU. Pharmilab analyzes your device's intended purpose and mode of action to accurately determine its class (I, IIa, IIb, or III) under MDR and IVDR regulations. This ensures you identify the correct legal requirements early, establishing a clear compliance roadmap to avoid costly delays with notified bodies.
Correct classification is the foundation of regulatory compliance for medical devices in the EU. Pharmilab analyzes your device's intended purpose and mode of action to accurately determine its class (I, IIa, IIb, or III) under MDR and IVDR regulations. This ensures you identify the correct legal requirements early, establishing a clear compliance roadmap to avoid costly delays with notified bodies.
Correct classification is the foundation of regulatory compliance for medical devices in the EU. Pharmilab analyzes your device's intended purpose and mode of action to accurately determine its class (I, IIa, IIb, or III) under MDR and IVDR regulations. This ensures you identify the correct legal requirements early, establishing a clear compliance roadmap to avoid costly delays with notified bodies.
National Notification
of Medical Devices
Registration and notification with INFARMED is mandatory for legally marketing medical devices in Portugal. Pharmilab handles the entire process, including identifying requirements, preparing documentation, and managing submissions for both general medical devices and in vitro diagnostics.
They support manufacturers, importers, and distributors by ensuring deadlines are met and managing updates for product changes or range extensions.
Registration and notification with INFARMED is mandatory for legally marketing medical devices in Portugal. Pharmilab handles the entire process, including identifying requirements, preparing documentation, and managing submissions for both general medical devices and in vitro diagnostics.
They support manufacturers, importers, and distributors by ensuring deadlines are met and managing updates for product changes or range extensions.
Registration and notification with INFARMED is mandatory for legally marketing medical devices in Portugal. Pharmilab handles the entire process, including identifying requirements, preparing documentation, and managing submissions for both general medical devices and in vitro diagnostics.
They support manufacturers, importers, and distributors by ensuring deadlines are met and managing updates for product changes or range extensions.
Preparation of Technical Documentation
Technical Documentation is the cornerstone of compliance with MDR and IVDR regulations. Pharmilab supports manufacturers and authorized representatives in structuring, developing, and reviewing these files for all device classes (I to III).
Their services range from full development (covering product description, risk management, clinical evaluation, labelling, and post-market surveillance) to gap analysis of existing files and assistance with essential supplementary documents like Declarations of Conformity.
Technical Documentation is the cornerstone of compliance with MDR and IVDR regulations. Pharmilab supports manufacturers and authorized representatives in structuring, developing, and reviewing these files for all device classes (I to III).
Their services range from full development (covering product description, risk management, clinical evaluation, labelling, and post-market surveillance) to gap analysis of existing files and assistance with essential supplementary documents like Declarations of Conformity.
Technical Documentation is the cornerstone of compliance with MDR and IVDR regulations. Pharmilab supports manufacturers and authorized representatives in structuring, developing, and reviewing these files for all device classes (I to III).
Their services range from full development (covering product description, risk management, clinical evaluation, labelling, and post-market surveillance) to gap analysis of existing files and assistance with essential supplementary documents like Declarations of Conformity.
CE Marking for Medical Devices
The CE marking is the final and mandatory step towards placing a medical device in the European Economic Area. This brand ensures that the product meets all safety, performance and quality requirements set out in European regulations — MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746).
We provide specialized assistance throughout the process of obtaining CE Marking, from the initial planning phase to submission and approval from the notified body (where applicable)
The CE marking is the final and mandatory step towards placing a medical device in the European Economic Area. This brand ensures that the product meets all safety, performance and quality requirements set out in European regulations — MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746).
We provide specialized assistance throughout the process of obtaining CE Marking, from the initial planning phase to submission and approval from the notified body (where applicable)
The CE marking is the final and mandatory step towards placing a medical device in the European Economic Area. This brand ensures that the product meets all safety, performance and quality requirements set out in European regulations — MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746).
We provide specialized assistance throughout the process of obtaining CE Marking, from the initial planning phase to submission and approval from the notified body (where applicable)
EUDAMED platform
EUDAMED is the centralized EU database designed to ensure transparency and traceability for medical devices under MDR and IVDR regulations. It is a mandatory tool for all stakeholders, including manufacturers, importers, and competent authorities. Pharmilab provides full support for the required registration and data submission processes, ensuring your company meets all legal and technical obligations.
EUDAMED is the centralized EU database designed to ensure transparency and traceability for medical devices under MDR and IVDR regulations.
It is a mandatory tool for all stakeholders, including manufacturers, importers, and competent authorities. Pharmilab provides full support for the required registration and data submission processes, ensuring your company meets all legal and technical obligations.
EUDAMED is the centralized EU database designed to ensure transparency and traceability for medical devices under MDR and IVDR regulations. It is a mandatory tool for all stakeholders, including manufacturers, importers, and competent authorities. Pharmilab provides full support for the required registration and data submission processes, ensuring your company meets all legal and technical obligations.
Regulatory Monitoring and Compliance Support
Post Market Surveillance and Vigilance
Continuous regulatory monitoring is critical to keeping medical devices compliant amidst constantly evolving MDRand IVDR standards. Pharmilab provides a proactive surveillance service that tracks legislative updates, analyzes their specific impact on your products, and supports the adaptation of your technical documentation and processes. This ensures continuous compliance, minimizing legal risks and preventing market disruptions.
Continuous regulatory monitoring is critical to keeping medical devices compliant amidst constantly evolving MDRand IVDR standards. Pharmilab provides a proactive surveillance service that tracks legislative updates, analyzes their specific impact on your products, and supports the adaptation of your technical documentation and processes. This ensures continuous compliance, minimizing legal risks and preventing market disruptions.
Post Market Surveillance and Vigilance
Appointment of the Person Responsible for Regulatory Compliance (PRRC)
Post-market surveillance (PMS) is mandatory under MDR and IVDR to ensure the long-term safety and performance of medical devices. Pharmilab helps implement these systems by developing monitoring protocols, managing incident reports and recalls, and preparing periodic surveillance reports. Their advisory services ensure that risks are identified and mitigated quickly, maintaining compliance and market confidence throughout the product's lifecycle.
Post-market surveillance (PMS) is mandatory under MDR and IVDR to ensure the long-term safety and performance of medical devices. Pharmilab helps implement these systems by developing monitoring protocols, managing incident reports and recalls, and preparing periodic surveillance reports. Their advisory services ensure that risks are identified and mitigated quickly, maintaining compliance and market confidence throughout the product's lifecycle.
Continuous regulatory monitoring is critical to keeping medical devices compliant amidst constantly evolving MDRand IVDR standards. Pharmilab provides a proactive surveillance service that tracks legislative updates, analyzes their specific impact on your products, and supports the adaptation of your technical documentation and processes. This ensures continuous compliance, minimizing legal risks and preventing market disruptions.
Appointment of the Person Responsible for Regulatory Compliance (PRRC)
Appointing a Person Responsible for Regulatory Compliance (PRRC) is a mandatory requirement under EU regulations (MDR/IVDR) to oversee device safety and conformity. Pharmilab offers this as an outsourced service, acting as your official PRRC to handle all regulatory obligations, including conformity assessments, risk management, and post-market surveillance.
This solution is particularly advantageous for micro and small companies, allowing them to ensure full legal compliance and reduce operational costs without the need to hire internal regulatory staff.
Post-market surveillance (PMS) is mandatory under MDR and IVDR to ensure the long-term safety and performance of medical devices. Pharmilab helps implement these systems by developing monitoring protocols, managing incident reports and recalls, and preparing periodic surveillance reports. Their advisory services ensure that risks are identified and mitigated quickly, maintaining compliance and market confidence throughout the product's lifecycle.
Appointment of the European Authorised Representative (EU REP / EC REP)
For manufacturers based outside the EU, appointing a European Authorised Representative (EC REP) is mandatory to market medical devices under MDR and IVDR. Pharmilab acts as your official EC REP, serving as the legal point of contact for EU authorities. They handle all regulatory obligations—including EUDAMED registration, incident reporting, document submission, and audit support—allowing non-EU companies to legally access the European market without establishing a physical presence there.
Appointing a Person Responsible for Regulatory Compliance (PRRC) is a mandatory requirement under EU regulations (MDR/IVDR) to oversee device safety and conformity. Pharmilab offers this as an outsourced service, acting as your official PRRC to handle all regulatory obligations, including conformity assessments, risk management, and post-market surveillance.
This solution is particularly advantageous for micro and small companies, allowing them to ensure full legal compliance and reduce operational costs without the need to hire internal regulatory staff.
Appointing a Person Responsible for Regulatory Compliance (PRRC) is a mandatory requirement under EU regulations (MDR/IVDR) to oversee device safety and conformity. Pharmilab offers this as an outsourced service, acting as your official PRRC to handle all regulatory obligations, including conformity assessments, risk management, and post-market surveillance.
This solution is particularly advantageous for micro and small companies, allowing them to ensure full legal compliance and reduce operational costs without the need to hire internal regulatory staff.
UDI (Unique Device Identification) Assignment and Management
The Unique Device Identification (UDI) is a mandatory tracking system for all medical devices under EU regulations (MDR/IVDR), designed to ensure full traceability and safety. Pharmilab manages the entire implementation process, from the correct assignment and validation of codes to their registration in the EUDAMED database. This service ensures your devices meet all technical deadlines, integrating UDI seamlessly into your internal processes to prevent market access delays.
The Unique Device Identification (UDI) is a mandatory tracking system for all medical devices under EU regulations (MDR/IVDR), designed to ensure full traceability and safety. Pharmilab manages the entire implementation process, from the correct assignment and validation of codes to their registration in the EUDAMED database. This service ensures your devices meet all technical deadlines, integrating UDI seamlessly into your internal processes to prevent market access delays.
The Unique Device Identification (UDI) is a mandatory tracking system for all medical devices under EU regulations (MDR/IVDR), designed to ensure full traceability and safety. Pharmilab manages the entire implementation process, from the correct assignment and validation of codes to their registration in the EUDAMED database. This service ensures your devices meet all technical deadlines, integrating UDI seamlessly into your internal processes to prevent market access delays.
Labeling and Instructions for Use (IFU)
Labelling and Instructions for Use (IFU) are critical for medical device safety and compliance under MDR and IVDR regulations. Pharmilab provides specialized support to review and develop these materials, ensuring they contain all mandatory elements, use correct harmonized symbols, and are translated accurately for European markets. This service guarantees that your product information is legally valid, clear to the user, and fully aligned with regulatory standards
Labelling and Instructions for Use (IFU) are critical for medical device safety and compliance under MDR and IVDR regulations. Pharmilab provides specialized support to review and develop these materials, ensuring they contain all mandatory elements, use correct harmonized symbols, and are translated accurately for European markets. This service guarantees that your product information is legally valid, clear to the user, and fully aligned with regulatory standards
Labelling and Instructions for Use (IFU) are critical for medical device safety and compliance under MDR and IVDR regulations. Pharmilab provides specialized support to review and develop these materials, ensuring they contain all mandatory elements, use correct harmonized symbols, and are translated accurately for European markets. This service guarantees that your product information is legally valid, clear to the user, and fully aligned with regulatory standards
Submission to Notified Bodies
Labeling and Instructions for Use (IFU)
Support for the choice of the most appropriate notified body, preparation of technical documentation and monitoring throughout the certification process. Mandatory for all medical devices, however, for class I devices, only NB is required if they are sterile, measuring or reusable devices.
Support for the choice of the most appropriate notified body, preparation of technical documentation and monitoring throughout the certification process. Mandatory for all medical devices, however, for class I devices, only NB is required if they are sterile, measuring or reusable devices.
Support for the choice of the most appropriate notified body, preparation of technical documentation and monitoring throughout the certification process. Mandatory for all medical devices, however, for class I devices, only NB is required if they are sterile, measuring or reusable devices.
Conquer the world
with your brand
Fill out the form today and experience expert services
Conquer the world
with your brand
Fill out the form today and experience expert services
Conquer the world
with your brand
Fill out the form today and experience expert services