Medical Device Trial

Medical Device Investigations within the EU

Medical devices can only be introduced in the EU market after having been approved to be suitable, safe and effective.

 Scope of Medical Device Clinical Studies: 

  1. Clinical Investigations
  2. Performance evaluations
  3. Post marketing/Approval Studies 

Clinical Investigation Defined:

“Systematic Investigation in one or more human subjects, undertaken to assess the safety or performance of medical device” (ISO 14155) 

Performance Evaluation Defined:

“Investigation of an in-vitro diagnostic medical device intended to validate the performance claims under the anticipated conditions of use” (BS EN 13612: 2002) 

Post marketing/Approval Studies Defined

Clinical Study in human subjects of a CE-marked device (being used within indication) to evaluate additional parameters 

All EU MD investigations must comply with the related Directives:

  •        Active Implantable Directive (AIMDD) 90/385/ EEC, 2007/47/EC  
  •        Medical Device Directive (MDD) 93/42/EEC, 2007/47/EC  
  •        In vitro diagnostic medical devices Directive (IVDMD) 98/79/ECC
  •        EU Medical Device Regulation 2017/745 

As well as must be conducted in compliance with the harmonised standards:

  •        ISO 14155:2011 (Clinical Investigation of Medical Devices for Human Subjects - Good clinical practice)
  •        BS EN 13612:2002 – performance evaluation of in vitro diagnostic medical devices 

Even though European countries are working according to European regulations, some countries have their own specific additional requirements. 

 CLAUSE will provide you with the information regarding medical device investigation conducting at any country you may be interested in and will give a support on each stage of your trial. 

 CLAUSE is always at your service and is a reliable support for your trial!

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