Regulatory Pathways for Medical Devices and Drugs in the Netherlands: An Overview

By Dr. Leonie Esra Eyiis
On
In Blog, News & Insights

The regulatory framework for both medical devices and medicinal products in the Netherlands is shaped by European Union (EU) regulations, as well as national and local authorities. The following breakdown outlines the key processes and regulatory bodies involved in clinical research and product approval within the Netherlands.

Medical Devices

In the Netherlands, medical devices are regulated under the EU Medical Device Regulation (MDR 2017/745) and In-Vitro Diagnostic Regulation (IVDR 2017/746). These regulations apply across all EU member states, ensuring that medical devices and in-vitro diagnostics meet high safety and performance standards.

Clinical Research Involving Medical Devices

Before a new medical device can be marketed, it may require clinical investigations. The CCMO plays a critical role in overseeing ethical approval for clinical research involving human subjects.

  1. Ethical Review: Clinical trials involving medical devices must be ethically reviewed and approved by MREC (Medical Research Ethics Committees), which ensures that research involving human participants is ethically conducted. In some cases, CCMO may also be involved in the approval process.
  2. Conformity Assessment: Once the clinical trial is approved, the device must go through a conformity assessment procedure to ensure compliance with the MDR or IVDR, depending on the type of device.
  3. Role of Notified Bodies: For most medical devices, especially those in higher-risk categories (Classes IIa, IIb, and III), the involvement of a Notified Body is mandatory. These are accredited organizations that assess the compliance of the medical device with the relevant EU regulations. For Class I devices, self-certification may be possible, but higher-risk devices require additional third-party review.
  4. EUDAMED Database: Once the device passes the conformity assessment and receives CE marking, the product must be registered in the EUDAMED database (European Database on Medical Devices), which is a comprehensive database managed by the European Commission to track the performance and safety of medical devices in the EU.
  5. Marketing Authorization: After receiving CE marking and passing the necessary assessments, the device can be marketed in the EU, including the Netherlands, following registration with the Dutch Health and Youth Care Inspectorate (IGJ) for local market surveillance.

Medicinal Products (Drugs)

Medicinal products, including pharmaceuticals and biologics, are regulated by the European Medicines Agency (EMA), which ensures that drugs meet rigorous safety, quality, and efficacy standards before being approved for market use. In some cases, CBG (Dutch Medicines Evaluation Board) is responsible for national approvals.

Clinical Research Involving Drugs

Clinical trials for drugs must undergo review and approval to ensure patient safety and data integrity. In the Netherlands, the CCMO and MREC are key authorities in this process.

  1. Ethical and Scientific Review: Similar to medical devices, clinical research involving drugs must be ethically reviewed by MREC and approved by the CCMO to ensure the research complies with ethical principles, Good Clinical Practice (GCP) guidelines, and regulatory standards.
  2. Compliance with the WMO: Clinical trials on medicinal products must also adhere to the WMO (Medical Research Involving Human Subjects Act), a Dutch regulation that governs the conduct of medical research in the Netherlands and ensures participant protection.

Marketing Authorization and Drug Approval

  1. Marketing Authorization Application (MAA): After the successful completion of clinical trials, a Marketing Authorization Application (MAA) is submitted to the EMA for a centralized review. This is mandatory for certain types of drugs, such as biologics and new molecular entities.
  2. Role of CBG: The CBG is responsible for evaluating medicinal products intended for use exclusively in the Netherlands or for national review. If a drug is not subject to the EMA’s centralized procedure, the CBG can approve it for national use within the Netherlands.
  3. EU Marketing Authorization: For drugs approved through the EMA, the authorization granted allows marketing across the EU and EEA member states, including the Netherlands.
  4. Pharmacovigilance: After approval, both EMA and CBG are involved in pharmacovigilance, monitoring the safety of the drug in the market. Adverse drug reactions (ADRs) must be reported by companies to the appropriate authorities.

Role of Key Authorities

  • EMA (European Medicines Agency): The EMA is responsible for the centralized approval process of drugs and provides scientific advice on the safety, efficacy, and quality of medicinal products across the EU. The agency ensures that drugs meet high standards before they are made available for market use across EU/EEA member states.
  • CBG (Dutch Medicines Evaluation Board): The CBG is the national authority responsible for evaluating medicines intended for use within the Netherlands. The CBG plays a critical role in reviewing drugs for national approval, overseeing post-market safety, and conducting pharmacovigilance.
  • MREC (Medical Research Ethics Committees): These committees review and approve clinical trials involving human participants to ensure that the research is ethically and scientifically sound. MREC approval is required for clinical trials on both medical devices and drugs.
  • IGJ (Health and Youth Care Inspectorate): The IGJ ensures that healthcare products, including medical devices and drugs, are safe and effective once on the market. The IGJ is also involved in post-market surveillance and regulatory enforcement.
  • CCMO (Central Committee on Research Involving Human Subjects): The CCMO ensures that clinical research involving human participants adheres to ethical standards and regulatory requirements. The CCMO reviews research protocols and ensures that risk management and participant protection measures are in place.

Post-Market Surveillance and Vigilance

After a medical device or drug is authorized for sale, it is subject to ongoing post-market surveillance to monitor its safety and performance. Both EMA and CBG, along with the Health and Youth Care Inspectorate (IGJ), play an important role in ensuring that any safety concerns are promptly addressed. Manufacturers are required to report adverse events, and further clinical investigations or safety updates may be mandated if necessary.

Conclusion

The clinical regulatory pathways for both medical devices and drugs in the Netherlands are robust and aligned with European regulations. These pathways involve a complex process of approval, ethical review, and post-market monitoring. Key authorities such as the EMA, CBG, CCMO, MREC, and IGJ all play significant roles in ensuring the safety, efficacy, and ethical conduct of clinical research and the products that ultimately reach patients. Additionally, systems such as EUDAMED, Notified Bodies, and MDR/IVDR regulations ensure that medical devices meet the high standards required for patient safety.

Keywords: Medical Devices, Medicinal Products, Clinical Research, EMA, MDR 2017/745.

References

  1. European Union (EU). (2017). Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (MDR). https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745
  2. European Union (EU). (2017). Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices (IVDR). https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0746
  3. European Commission. (n.d.). EUDAMED – European Database on Medical Devices. https://ec.europa.eu/health/medical-devices-sector/new-regulations/eudamed_en
  4. European Medicines Agency (EMA). (n.d.). About Us. https://www.ema.europa.eu/en/about-us
  5. Dutch Medicines Evaluation Board (CBG). (n.d.). Medicines Evaluation in the Netherlands. https://www.cbg-meb.nl/
  6. Central Committee on Research Involving Human Subjects (CCMO). (n.d.). About CCMO. https://www.ccmo.nl/
  7. Medical Research Ethics Committees (MREC). (n.d.). Role and Responsibilities. Information available via CCMO: https://www.ccmo.nl/
  8. Health and Youth Care Inspectorate (IGJ). (n.d.). About IGJ. Retrieved from https://english.igj.nl/
  9. Government of the Netherlands. (n.d.). Medical Research Involving Human Subjects Act (WMO). https://wetten.overheid.nl/BWBR0009408/ (Dutch resource)
  10. European Medicines Agency (EMA). (n.d.). Pharmacovigilance and Safety Monitoring. https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance

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