Clinical investigations of medical devices

Clinical investigations of medical devices

A clinical investigation is defined as any systematic investigation or study in or on one or more human subjects, undertaken to assess the safety, clinical performance and/or effectiveness of a medical device.

  • In the European Union, USA, and Latin American countries clinical investigations of medical devices is a binding requirement for the most high-risk medical devices.
  • Clinical investigations are conducted when existing clinical data (e.g. collected by means of Clinical Evaluation) are not sufficient to demonstrate safety and performance of a medical device.
  • Usually, clinical investigations of medical devices are simpler and take less time than clinical trials of drugs. However, clinical programs for medical devices must conform to the international standards for clinical research (first of all, ICH GCP, the Declaration of Helsinki and ISO 14155) and be scientifically sound. Besides, they should be in line with all applicable national requirements in countries where they are conducted.

A clinical investigation is defined as any systematic investigation or study in or on one or more human subjects, undertaken to assess the safety, clinical performance and/or effectiveness of a medical device.

  • In the European Union, USA, and Latin American countries clinical investigations of medical devices is a binding requirement for the most high-risk medical devices.
  • Clinical investigations are conducted when existing clinical data (e.g. collected by means of Clinical Evaluation) are not sufficient to demonstrate safety and performance of a medical device.
  • Usually, clinical investigations of medical devices are simpler and take less time than clinical trials of drugs. However, clinical programs for medical devices must conform to the international standards for clinical research (first of all, ICH GCP, the Declaration of Helsinki and ISO 14155) and be scientifically sound. Besides, they should be in line with all applicable national requirements in countries where they are conducted.

Send us an email at: info@mdrc-consulting.com

Or use the contact form      

Send us an email at: info@mdrc-consulting.com

Or use the contact form      

CLINICAL INVESTIGATIONS OF MEDICAL DEVICES

In the European Union class III, active implantable medical devices and some of class IIb medical devices are subject to clinical investigations. In the case of some high-risk devices clinical investigations might be waived but the waiver must be appropriately justified.

In the US almost all class III devices and approximately 10-15% of class II devices, which are not 510(k) exempts, require clinical investigations. Usually, FDA recognizes clinical investigations conducted outside the United States provided that they comply with the international clinical research standards.

In the Latin American countries clinical investigations are required for high-risk products (classes III and IV in Brazil, Argentina and other Mercosur countries, class III in Mexico). Mostly, these regulatory authorities accept clinical investigations conducted in other countries provided that they comply with the international clinical research standards.

CLINICAL INVESTIGATIONS OF MEDICAL DEVICES

In the European Union class III, active implantable medical devices and some of class IIb medical devices are subject to clinical investigations. In the case of some high-risk devices clinical investigations might be waived but the waiver must be appropriately justified.

In the US almost all class III devices and approximately 10-15% of class II devices, which are not 510(k) exempts, require clinical investigations. Usually, FDA recognizes clinical investigations conducted outside the United States provided that they comply with the international clinical research standards.

In the Latin American countries clinical investigations are required for high-risk products (classes III and IV in Brazil, Argentina and other Mercosur countries, class III in Mexico). Mostly, these regulatory authorities accept clinical investigations conducted in other countries provided that they comply with the international clinical research standards.

12+

YEARS’ EXPERIENCE

200+

COMPLETED PROJECTS

100+

REGULATORY SUBMISSIONS

50+

NEW PRODUCTS

MDRC assists medical device companies with clinical investigations organization and conduct:

  • Clinical strategy development (what investigations are required, how to conduct them efficiently, what investigations can be waived etc.)
  • Writing clinical investigation plans
  • Creating clinical investigation documentation needed for investigation approval
  • Coordination with clinical sites and contract research organizations
  • Regulatory authorities liaison

MDRC assists medical device companies with clinical investigations organization and conduct:

  • Clinical strategy development (what investigations are required, how to conduct them efficiently, what investigations can be waived etc.)
  • Writing clinical investigation plans
  • Creating clinical investigation documentation needed for investigation approval
  • Coordination with clinical sites and contract research organizations
  • Regulatory authorities liaison

CONTACT US

whether you have a question about our solutions or need help with your new project

    Contact us whether you have a question about our solutions or need help with your new project