When it comes to conducting clinical studies on medical devices in the European Union, there are distinct documents that regulate this process. EN ISO 14155:2011, Directive 93/42/EEC Annex X, Directive 90/385/EEC Annex 7 and Directive 95/46/EC are all guidelines regarding medical device clinical trials in the EU. Each one of these documents regulate across all Member States, however, there are also Member State laws that can affect clinical trials.
Details regarding the design, conduct, recording and reporting of medical device clinical studies are provided in EN ISO 14155:2011. This standard does not apply to in vitro diagnostic medical devices. This standard defines general requirements to protect the rights and safety of the human subjects involved, ensure the scientific conduct and credibility of the investigation and identify sponsor and investigator responsibilities. It also assists regulatory authorities and other bodies involved in the conformity assessment.
Directive 93/42/EEC Annex X and Directive 90/385/EEC Annex 7 explain the general provisions of clinical evaluations and specifies objectives, ethical considerations and methods of clinical investigations. However, Directive 93/42/EEC Annex X is specific to medical devices where Directive 90/385/EEC Annex 7 is specific to implantable medical devices. Both of these directives state that “it is mandatory that all measure relating to the protection of human subjects are carried out in the spirit of the Helsinki Declaration.”
Guidelines on individual data protection and on the free movement of such data is discussed in Directive 95/46/EC. This directive establishes the need for informed consent from individuals involved with a clinical investigation. It outlines how personal data is to be collected and processed, as well as the rights the subject has to the data, such as access and objections. How personal data is to be transferred from a Member State to a third country is also specified.
Each Member State has their own set of laws to govern over the country, including laws regarding medical device clinical investigations. Sponsors of the clinical investigation must report serious adverse events to the necessary authority, but some Member States, such as France, Germany and Spain, require the clinical investigators to report such events separately to Ethics Committees and/or to other investigators and study centers involved. Additionally, with regards to data privacy, Member States establish their own exceptions to data protection laws and may require further prior checking to be carried out before data processing can begin . It is essential to verify and understand the national laws before conducting a clinical trial in the preferred Member State.
Another important step to take before beginning a clinical trial is selecting an investigator for your study. There are several factors that influence who is selected as your investigator.
Check out the next blog in this series, Things to Consider When Selecting a Clinical Investigator.
If you missed the previous blog in this series, Conducting a Clinical Study in the US, you can view it here.