Regulatory Process for Medical Devices - Nemko Process... · European Regulatory regime Directives:...
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Regulatory Process for Medical Devices
Transcript of Regulatory Process for Medical Devices - Nemko Process... · European Regulatory regime Directives:...
Regulatory Process for
Medical Devices
• European definition of medical device
• Intended use/ medical purpose
• Manufacturers role and responsibility
Medical Regulatory definitions
European Regulatory regime
Directives:
• “Directive 90/385” means Council Directive 90/385/EEC
of 20th June 1990 on implantable medical devices
• “Directive 93/42” means Council Directive 93/42/EEC of
14th June 1993 on medical devices
• “Directive 98/79” means Directive 98/79/EC of 27th
October 1998 on in vitro diagnostic medical devices
• Forskrift om medisinsk utstyr/Regulation of medical
devices. FOR-2005-12-15-1690
• Brukerforskriften/User Regulation. FOR-2013-11-29-1373
• Class I
• Class IIa
• Class IIb
• Class III
Risk classification of medical device
Main harmonized standards
Normally used to demonstrate
compliance to European Directive.
To find what standards:
• Official Journal
Where to get standards:
• www.standard.no
• www.ds.dk
• www.sis.se
Safety for electromedical device
General standard
(part 1 standard)
IEC 60601-1
Collateral standards
IEC 60601-1-xx
… 60601-1-2 60601-1-12
60601-2-2Particular standards
(part 2 standards)
IEC 60601-2-xx
IEC/ISO 80601-2-xx
60601-2-1
60601-2-75
80601-2-12
80601-2-74
• Basic Safety - Physical HAZARDS
• Essential Performance
• Risk Management Process
• Clinical Performance
• Manufacturer of Medical Device
Technical file content
• Medical device functions must be matched with the
wireless technology’s capabilities and performance.
Different wireless technologies
• Short range
• Inductive implants < 200 KHz
• MICS (Medical Device Radiocomm Service) 401-406
MHz
• WIFi, Bluetooth, Zigbee 2,4 GHz, 5,7 GHz
• UWB (Ultra Wide Band)
• Long range
• WMTS (Wireless Medical Telemetry)
• WiMax
Selecting wireless technology
Software
• Software used in Medical Devices
• Stand alone software inclusive
apps which meets the definition
of a medical device
• Check the specifications from purchasers.
Assistance devices
• CE marking.
• Notified Body. + notification number
• The Manufacturer must register the device at the national
authorities.
• www.helsedirektoratet.no Utstyrsregisteret/equipment register
• www.laegemiddelstyrelsen.dk Registrering/registration
• www.lakemedelsverket.se Registrering /registration
Placed on markets in EU/EEA
• North-America
• Outside EU/EEA each country have their national
regulation/law for medical devices.
Markets outside EU/EEA
Summary
Contact information:
• Norway: Geir Olav Wang
[email protected], phone: +47 928 014 66
• Denmark: Morten Hougaard:
[email protected], phone: +45 222 002 45
• Sweden: Jens Bryntesson:
[email protected], phone: +46 708 11 97 17
Contact and Questions
