Medical device trials

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


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 trial conducting at any country you may be interested in.

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

News and events

Clause will participate in Arabian Health
24.01.2017
Clause will participate in Arabian Health

News
21.09.2016
CLAUSE Ltd, the leading contract research organization in Europe is pleased to announce the opening of a new branch office in Praha, Czech Republic.

Сontacts

We will be glad to cooperate

Feel free to contact us for any questions using any convinient way for you!

Tel +38 095 596 0666; +38 057 751 66 99

e-mail: office@clause-audit.com

Address: 20V, Kul'tury str., off.19

Kharkiv ,61058,Ukraine

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