Worldwide Regulation

European Union, CE mark, CE marked, medical device European market, medical devices, MDR, Regulation 2017/745, safety, effectiveness, safe, effective, general safety and performance requirements, EU market, risk based system

European Union

The Medical Device Regulation (EU) 2017/745 (MDR) is the law that governs the placing of medical devices on the European market. It fully replaced the old Medical Device Directive (MDD 93/42/EEC) and Active Implantable Medical Device Directive (AIMDD 90/385/EEC). The MDR creates a strict, risk-based system to ensure that only safe and effective medical devices with proven clinical benefits can be placed on the EU market.
The MDR applies to:●Medical devices (instruments, apparatus, machines, implants, software, etc.) used for diagnosis, prevention, monitoring, treatment, or alleviation of disease.● Accessories for medical devices.●Certain non-medical products listed in Annex XVI (e.g., cosmetic contact lenses, liposuction equipment).

  • • Implement a Quality Management System (QMS). ISO 13485 is the usual standard.
    • Perform a Clinical Evaluation, including clinical data, literature, or clinical investigations.
    • Conduct Risk Management according to ISO 14971.
    • Demonstrate safety, performance, and benefit–risk balance.
    • Prepare and maintain a Technical Documentation (Technical File).
    • Undergo a Conformity Assessment by a Notified Body (for Class Is/Im/Ir, IIa, IIb, III).
    • Obtain CE marking before placing the device on the market.

  • The person responsible for regulatory compliance (PRRC) is an individual designated by medical device manufacturers, authorized representatives and importers who oversees regulatory adherence for medical devices placed on the EU market.
    Key Responsibilities● Ensure that the conformity of devices is correctly checked according to the quality management system before release.● Confirm that the technical documentation and EU declaration of conformity are drawn up and kept up to date.● Make sure that post-market surveillance and vigilance reporting obligations (serious incidents, field safety actions, trend reporting) are met.● For investigational devices, ensure that required statements are issued.
    Qualifications
    The PRRC must have specific qualifications: a degree in a relevant scientific field and at least one year of regulatory or quality management experience with medical devices, or four years of professional experience in these fields in the absence of such a degree.
    Appointment    ● Micro and small enterprises may outsource the PRRC function, but must have continuous access to a qualified individual.● The PRRC must be operationally “close” to the manufacturer (within the EU for EU manufacturers; for non-EU manufacturers, the PRRC can be outside the EU).● Name and contact details of the PRRC must be registered in the EUDAMED database.

  • • Prepare Post-Market Surveillance (PMS) Plan and Periodic Safety Update Reports (PSUR) (for Class IIa, IIb and III) or Post-Market Surveillance (PMS) Report (for Class I).
    • Report vigilance incidents (serious incidents, field safety corrective actions).
    • Update technical documentation continuously.

  • MDR requires registration of devices, manufacturers, and certificates in EUDAMED, the EU database.
    EUDAMED is being rolled out in modules, with full functionality expected by 2027.

  • Competent Authorities are the national regulators for medical devices in the European Union. Each Member State appoints its Competent Authority.They enforce MDR requirements, supervise Notified Bodies, oversee vigilance and market surveillance, and ensure device safety at the national level while coordinating with the EU.
    Main Responsibilities of Competent Authorities:• Supervise manufacturers, importers, and distributors established in their country.• Designate and monitor Notified Bodies that perform conformity assessments.• Oversee vigilance reporting (serious incidents and field safety corrective actions).• Conduct market surveillance (checking devices already on the market).• Ensure registration in EUDAMED of economic operators and devices.• Cooperate with other CAs and the European Commission to ensure harmonized enforcement across the EU.
    Examples of Competent Authorities:• Germany → BfArM (Federal Institute for Drugs and Medical Devices).• France → ANSM (National Agency for Medicines and Health Products Safety).• Italy → Ministry of Health (Ministero della Salute).• Spain → AEMPS (Spanish Agency of Medicines and Medical Devices).
    The European Commission maintains a section that provides links to contact points within each Member State. You can check it in the following link: Link to European Commission 

Classification

MDR, European medical device classification, medical devices, sterile, measuring function, low risk, high risk, moderate risk, Regulation 2017/745, reprocessable surgical instruments, class I, class Is, class Im, class Ir, class IIa, class IIb, class III
Switzerland, medical devices, Swissmedic, MedDO, SR 812.213, Swiss Agency for Therapeutic Products, safety, vigilance, clinical investigations, post-market surveillance, MDR, Regulation 2017/745

Switzerland

The main law regulating medical devices in Switzerland is the Swiss Medical Devices Ordinance (MedDO, SR 812.213).
Switzerland is not part of the EU, but Swiss law is aligned with the EU MDR (2017/745) and IVDR (2017/746) to ensure market access and patient safety. Switzerland recognizes CE-marked medical devices under the MDR/IVDR for placing devices on the Swiss market.
The national regulator is Swissmedic, the Swiss Agency for Therapeutic Products. Swissmedic oversees device safety, vigilance, clinical investigations, and post-market surveillance.
After the end of the EU–Switzerland Mutual Recognition Agreement (MRA) in 2021, Switzerland is treated as a third country. This means additional obligations for manufacturers, importers, and distributors. Negotiations are currently underway to reinstate this agreement, and although it appears that these negotiations are proving satisfactory for both parties, there is still no date on which it can be guaranteed that the Mutual Recognition Agreement will come back into force.

  • All operators (manufacturers, importers, CH-REPs) must register with Swissmedic and obtain a Swiss Single Registration Number (CHRN).

  • Devices are classified using the same risk classes and rules as the EU MDR (I, IIa, IIb, III) and Post-Market Obligations are the same as the EU MDR.

  • Swissdamed is Switzerland's national database for medical devices, managed by Swissmedic, the Swiss Agency for Therapeutic Products. It serves as a central platform for registering medical devices, including in vitro diagnostic devices, and the economic operators responsible for them. The database aims to enhance transparency and oversight of medical devices available on the Swiss market.
    Currently, there is no direct interface between Swissdamed and the European database EUDAMED. As a result, Swissmedic cannot import or synchronize data from EUDAMED. Economic operators are required to manually upload their device data to Swissdamed. For this purpose, an XML file in EUDAMED 'GET DEVICE' or 'POST DEVICE' format can be used. Further upload methods, such as machine-to-machine interfaces, are planned for future implementation.
    📅 Key Dates• August 2024: Actors Module went live. • August 2025: UDI Devices Module became available for voluntary registration. • July 1, 2026: Mandatory registration for devices placed on the Swiss market begins.• December 31, 2026: End of the transitional period for registration.
    Devices subject to reporting obligations for serious incidents, field safety corrective actions, or trends will require immediate registration from July 1, 2026.

United States, FDA,

The United States

The main law regulating the medical devices in the US is the Federal Food, Drug, and Cosmetic Act (FD&C Act). Regulations are found in Title 21 of the Code of Federal Regulations (21 CFR), Chapter I, Subchapter H.

The U.S. Food and Drug Administration (FDA) is the regulator authority responsible for medical devices in the United States.

  • 510(k) Premarket Notification – For most Class II devices, showing substantial equivalence to a legally marketed device.
    De Novo Classification – For novel, low-to-moderate risk devices without a predicate.
    Premarket Approval (PMA) – For Class III, high-risk devices, requiring full safety and effectiveness evidence (often including clinical trials).
    Exempt Devices – Many Class I and some Class II devices are exempt from premarket submissions, but still must follow general controls.

  • Manufacturers must implement a Quality Management System under 21 CFR Part 820 (QSR).
    FDA is in the process of aligning the QSR with ISO 13485:2016 (this will be the new Quality Management System Regulation, QMSR).

  • • Follow Medical Device Reporting (MDR) requirements for adverse events (21 CFR Part 803).
    • Conduct corrections and removals when safety issues arise (21 CFR Part 806).
    • Maintain Unique Device Identification (UDI) on labels and packages.
    • Comply with post-market surveillance studies if required by FDA.

Device Classification (Risk-based)

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FDA maintains a Product Classification Database where you can search by device name, product code, or regulation number: 👉 FDA Product Classification Database
Devices are classified under regulation numbers in 21 CFR Parts 862–892 (covering everything from in vitro diagnostics to radiology).

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United Kingdom

In the United Kingdom, medical devices are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). 
The regulatory framework is primarily governed by the UK Medical Devices Regulations 2002 (UK MDR 2002), which have been amended to reflect the UK's departure from the European Union. 

  • In the United Kingdom, the classification of medical devices continues to follow the framework of the former Medical Devices Directive (93/42/EEC), whereas the European Union now applies the stricter and more detailed classification system set out in the Medical Device Regulation (EU) 2017/745.
    The classification determines the route for regulatory conformity, including requirements for approval bodies and evidence before devices may be marketed. Classification rules are found in Annex IX (as modified by Schedule 2A) to UK MDR 2002; devices are assigned based on invasiveness, duration, purpose, and other risk factors.

  • Manufacturers must ensure their devices meet the necessary safety and performance standards before placing them on the market in Great Britain (England, Wales, and Scotland). This involves obtaining a UK Conformity Assessed (UKCA) mark, which indicates compliance with UK regulations. For higher-risk devices, this may require assessment by a UK approved body.

  • All medical devices, including in vitro diagnostic devices (IVDs), custom-made devices, and systems or procedure packs, must be registered with the MHRA before they can be placed on the market in Great Britain. Manufacturers based outside the UK must appoint a UK Responsible Person to act on their behalf for registration purposes.

  • Manufacturers are required to proactively monitor the safety and performance of their devices once they are on the market. This includes reporting any incidents or adverse events to the MHRA and taking corrective actions as necessary. 

  • The UK continues to accept CE-marked medical devices on the Great Britain market under certain conditions.
    Medical devices compliant with the EU MDD or EU AIMDD can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2028.
    Medical devices, including custom-made devices, compliant with the EU MDR can be placed on the Great Britain market up until 30 June 2030.

  • The UK government is working on implementing future regulations for medical devices to ensure patient safety and align with international standards. These developments aim to facilitate access to innovative medical technologies and foster international harmonization.

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Canada

The regulator is Health Canada, specifically the Medical Devices Directorate (MDD) within the Therapeutic Products Directorate (TPD). They oversee licensing, safety, and post-market surveillance.
The main law is the Food and Drugs Act. The detailed requirements are in the Medical Devices Regulations (SOR/98-282).

Classification

Classification, Canada, Health Canada, Medical Devices Regulations (SOR/98-282)

  • Class I: No license required, but companies must have an establishment license to import or distribute.
    Class II, III and IV: Require a Medical Device License (MDL) issued by Health Canada. Application must include safety, effectiveness, and quality evidence. For Class III and IV, clinical data is usually required.
    For Medical Device License (MDL) application, the following documentation is required:
    ● Device Description and Classification● Manufacturer Information● Regulatory Correspondent Info● Intended Use/Purpose● Quality Management System Certificate (ISO 13485 certificate)● List of Standards Complied With●Attestations (signed statements by a senior official confirming all regulatory requirements and evidence reviewed for compliance)● Clinical Data on Safety and Effectiveness (for Class III and IV devices)● Labeling● Fee Form and Payment● Signature of Authorized Representative● Additional Supporting Documentation may be requested

  • For Class II, III, and IV, manufacturers must implement a QMS certified to ISO 13485 under the Medical Device Single Audit Program (MDSAP).
    MDSAP audits are mandatory for Canada since January 2019.

  • • Report serious incidents and recalls to Health Canada.• Create and retain summary reports addressing adverse effects, corrective actions, complaints, and incidents (similar to PSUR in Europe). For Class II devices, reporting periods can be up to two years and for Class III and IV devices, reporting typically occurs annually.• Maintain distribution records for traceability.

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Ukraine

In Ukraine, the regulation of medical devices is governed by national technical regulations aligned with European Union standards, aiming to ensure the safety, efficacy, and quality of medical products.
Ukraine's medical device regulations are based on the following key technical regulations: • Cabinet of Ministers Resolutions No. 753, 754, and 755 (2013): These resolutions establish the technical requirements for medical devices, in vitro diagnostic devices, and active implantable medical devices, respectively.• Law of Ukraine on Technical Regulations and Conformity Assessment: This law outlines the procedures for conformity assessment and market surveillance of medical devices.
Ministry of Health of Ukraine is responsible for the technical regulation of medical devices and State Service of Ukraine on Medicines and Drugs Control oversees market surveillance and compliance enforcement.

  • Medical devices in Ukraine are classified according to risk, following systems similar to European Union regulations. 
    ● Class I: Non-sterile and non-measuring devices; considered low-risk. These can undergo a simplified self-declaration process.● Class Is and Im: I(s) for sterile devices, I(m) for measuring devices; moderate risk requiring additional conformity procedures.● Class IIa: Moderate risk; typically invasive devices with short-term use.● Class IIb: Higher risk; more invasive or long-term devices.● Class III: Highest risk; life-supporting, life-sustaining, or devices that are implanted in the body.● Active Implantable Medical Devices (AIMD): Regulated similarly to Class III, including pacemakers and other implanted electronics.
    Ukraine’s classification is based on technical regulations that are being updated to further align with recent EU Medical Device Regulation.

  • Medical devices must undergo conformity assessment to demonstrate compliance with Ukrainian technical regulations. The procedures vary based on the device classification: • Class I devices: These devices can be self-certified by the manufacturer. • Class IIa and IIb devices: These require an examination of the manufacturer's quality assurance system, including an inspection of the manufacturing site by an authorized body. • Class III devices and Active Implantable Devices: These necessitate a design examination along with an inspection of the manufacturing site.
    For devices already bearing a CE mark, a simplified recognition procedure may be available, subject to specific agreements between Ukrainian and European conformity assessment bodies. 

  • Manufacturers must prepare and submit the following documents:• Technical Documentation: Demonstrating compliance with essential requirements.
    • Declaration of Conformity: Affirming that the device meets all regulatory requirements.
    • Labeling: Including the Ukrainian language and the national conformity mark.
    • Instructions for Use: Provided in the Ukrainian language.

  • In 2024, Ukraine enhanced its digital infrastructure for medical device registration, introducing electronic services that streamline the submission process for EU and Chinese suppliers. Additionally, the use of QR codes on medical device labels became more widespread, providing direct access to instructions for use and certificates, aligning with EU trends in digital documentation.

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Mexico

Medical device regulation in Mexico is overseen by the Federal Commission for Protection against Sanitary Risks (COFEPRIS), a decentralized agency of the Secretariat of Health. 
The regulatory framework is primarily based on the General Health Law (Ley General de Salud) and supported by official Mexican standards known as NOMs (Normas Oficiales Mexicanas) and the Regulation of Health Supplies (Reglamento de Insumos para la Salud).
Manufacturers must adhere to NOM-241-SSA1-2012, which outlines Good Manufacturing Practices for medical device establishments in Mexico. This standard aligns partially with international standards like ISO 13485:2003 and ISO 9001:2008.

Classification

The classification is indeed based on the level of invasiveness and duration of contact with the human body.

medical device classification, Mexico, Mexican, COFEPRIS, level of invasiveness, implants, contact lenses, bandages, scalpel, gloves, sutures, infusion pump, regulation, NOM-241-SSA1-2012, reglamento de insumos para la salud, Regulation of Health Supplies

  • The registration process involves several key steps:
    1. Appointment of a Mexico Registration Holder (MRH): Foreign manufacturers must designate a local representative to handle regulatory matters and ensure compliance with COFEPRIS requirements.
    2. Submission of Documentation: Depending on the device classification, manufacturers must provide a comprehensive dossier that may include technical documentation, clinical evidence, labeling information, and proof of compliance with Good Manufacturing Practices (GMP).
    3. Review and Approval: COFEPRIS reviews the submitted documentation and, if satisfied, grants a sanitary registration, allowing the device to be marketed in Mexico.

  • In August 2025, COFEPRIS introduced reforms aimed at streamlining the regulatory process for medical devices and pharmaceuticals. These changes are expected to enhance efficiency and transparency in the approval process.

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Brazil

In Brazil, medical devices are regulated by the Agência Nacional de Vigilância Sanitária (ANVISA), which ensures the safety, efficacy, and quality of health products.
The regulatory framework is primarily governed by the Resolução da Diretoria Colegiada (RDC) 751/2022, effective since March 1, 2023. This regulation aligns with international standards and provides a comprehensive structure for the classification, registration, and post-market surveillance of medical devices. 

  • The registration process varies based on the device classification:
    ● Notificação (Notification): For Class I and II devices, manufacturers submit a simplified application to ANVISA.● Registro (Registration): For Class III and IV devices, a comprehensive technical dossier, including clinical data and Good Manufacturing Practice (GMP) certification, is required.

  • Manufacturers of Class III and IV devices must comply with Brazilian GMP standards, which align with international guidelines such as ISO 13485. GMP certification is mandatory and must be renewed periodically.

  • Depending on the device type, additional certifications may be required:
    ● INMETRO Certification: For devices like electromedical equipment, ensuring compliance with Brazilian safety and performance standards.● ANATEL Certification: For devices that use radio-frequency, ensuring compliance with telecommunications regulations.

  • Foreign manufacturers must appoint a Brazilian Registration Holder (BRH), a local entity responsible for submitting registration applications, liaising with ANVISA, and ensuring compliance with local regulations.

  • ANVISA requires ongoing monitoring of medical devices after they are approved and marketed. This includes reporting adverse events, conducting field safety corrective actions, and ensuring continuous compliance with regulatory standards.

Classification

Brazil’s RDC 751/2022 mirrors the EU MDR (2017/745) by adopting the same 22 classification rules based on invasiveness, duration of body contact, and whether the device is active. Both frameworks also include specific provisions for software and nanomaterials. 

The main difference is the naming of risk classes: Brazil uses I–IV, while the EU uses I, IIa, IIb, III, but in practice the mapping is nearly equivalent. Most rules are mirrored; moreover, Brazil’s RDC adds Brazil-specific deviations. Pay special attention to rules 2, 6, 8, and 16.

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