Regulation for Medical Devices

The term “medical devices” includes everything from highly sophisticated computerized medical equipment down to simple wooden tongue depressors. The intended primary mode of action of a medical device on the human body, in contrast with that of medicinal products, is not metabolic, immunological, or pharmacological.

 

Several different international classification systems for medical devices are still in use in the world today. The World Health Organization, with its partners, is working towards achieving harmonization in medical device nomenclature, which will have a significant impact on patient safety. The Global Harmonization Task Force has proposed the following harmonized definition for medical devices.

 

Medical device” means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purposes of:

 

• diagnosis, prevention, monitoring, treatment or alleviation of disease

 

• diagnosis, monitoring, treatment, alleviation of or compensation for an injury

 

• investigation, replacement, modification, or support of the anatomy or of a physiological process

 

• supporting or sustaining life

 

• control of conception

 

• disinfection of medical devices

 

• providing information for medical purposes by means of in vitro examination of specimens derived from the human body and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.”

 

 

 

Current legislation

 

Regulations relating to the safety and performance of medical devices in the EU were harmonised in the 1990s, following the New Approach on legislative principles. The core legal framework consists of three directives:

 

Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990)

 

Council Directive 93/42/EEC on Medical Devices (MDD) (1993)

 

Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDMD) (1998)

 

 

 

Additional literature

 

You can find regulation documents and same practice comments on websites listed below.

 

In case of general questions in topic of regulations in Poland and EU, we will try to help you- don’t heresies to ask (This email address is being protected from spambots. You need JavaScript enabled to view it..pl).

 

 

 

List of regulations: http://www.emergogroup.com/resources/regulations-europe

 

 EU regulations webside: http://medical-device.ce-marking.eu/

 

Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: http://bip.urpl.gov.pl/pl

 

Steps for Class III medical devices compliance

 

http://www.ce-marking.com/medical-devices-class-III.html

 

http://www.who.int/gho/publications/world_health_statistics/2016/en/

 

How are medical devices regulated in the European Union?

 

Elaine French-Mowat, Joanne Burnett doi: 10.1258/jrsm.2012.120036 J R Soc Med April 2012 vol. 105 no. suppl 1 S22-S28