Medical Device Trials

Medical devices can only be introduced in the EU market after having been approved to be suitable, safe and effective. Furthermore all medical devices in EU must be CE-certified. A CE marking will be attached on the medical device provided that the necessary essential requirements have been fulfilled and after having conducted the conformity assessment procedure. In the EU “notified bodies” are responsible for assessing conformity of medical devices with the relevant directives.

Medical Device Trials in Germany

When the 4th MPG (4th Medical Device Act) in Germany came into force on 21 March 2010, prerequisites for marketing authorization for medical devices became more demanding, because medical device manufacturers have to comply with numerous legal regulations and requirements for medical device trials. Medical devices have to provide evidence of the suitability for the specified intended purpose through a clinical evaluation based on clinical data unless, in exceptional cases with good reason, other data are sufficient.

European Directives European 90/385/EEC (active implantable medical devices), 93/42/EEC (medical devices), 98/79/EC (in vitro diagnostic medical devices) and also the amending Directive 2007/47/EC were implemented into German law by the MPG. In addition the following ordinances have to be taken into consideration:

• MPKPV (Medizinprodukte-Klinische Prüfungsverordnung, Ordinance on Clinical Trials with Medical Devices)
• MPSV (Medizinprodukte-Sicherheitsplanverordnung, Ordinance on medical devices vigilance)
• DIMDI Verordnung (Deutsches Institut für Medizinische Dokumentation und Information, German Institute of Medical Documentation and Information)

Furthermore, adherence to the following internationally accepted standards and guidelines is highly recommended:

• ISO 14155:2011
• MEDDEV 2.7.1 Rev. 3
• Declaration of Helsinki

In Germany conduct of clinical trials with medical devices requires approval by the competent federal authority BfArM (Federal Institute for Drugs and Medical Devices) or PEI (Paul Ehrlich Institute) and by Ethics Committee. Exemptions are possible for clinical investigations of medical devices with a negligible safety risk; in these cases the competent federal authority can waive the need for an authorization.

Vigilance

The handling of adverse events in clinical trials with medical devices differs from those with medicinal products. Reporting of incidents and/or AEs in clinical trials is described in MPSV. Investigators and Sponsors must report SAEs electronically to the competent federal authority from clinical trials conducted in Germany (section 3 (5) MPSV).

For clients who are confronted with this challenge, the experience of CONET's team in the field of clinical trials is at your service:

Start-up Services Regulatory Affairs Project Management Clinical Monitoring Quality Assurance / Management Safety and Medical Affairs Data Management and Statistics Clinical Logistics Services

Please feel free to contact us anytime for more information on how we can support your medical device trial.