![Page 1: Regulatory Process for Medical Devices - Nemko Process... · European Regulatory regime Directives: •“Directive 90/385” means Council Directive 90/385/EEC of 20th June 1990](https://reader036.vdocuments.us/reader036/viewer/2022081723/5ac387407f8b9a57528c3357/html5/thumbnails/1.jpg)
Regulatory Process for
Medical Devices
![Page 2: Regulatory Process for Medical Devices - Nemko Process... · European Regulatory regime Directives: •“Directive 90/385” means Council Directive 90/385/EEC of 20th June 1990](https://reader036.vdocuments.us/reader036/viewer/2022081723/5ac387407f8b9a57528c3357/html5/thumbnails/2.jpg)
• European definition of medical device
• Intended use/ medical purpose
• Manufacturers role and responsibility
Medical Regulatory definitions
![Page 3: Regulatory Process for Medical Devices - Nemko Process... · European Regulatory regime Directives: •“Directive 90/385” means Council Directive 90/385/EEC of 20th June 1990](https://reader036.vdocuments.us/reader036/viewer/2022081723/5ac387407f8b9a57528c3357/html5/thumbnails/3.jpg)
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
![Page 4: Regulatory Process for Medical Devices - Nemko Process... · European Regulatory regime Directives: •“Directive 90/385” means Council Directive 90/385/EEC of 20th June 1990](https://reader036.vdocuments.us/reader036/viewer/2022081723/5ac387407f8b9a57528c3357/html5/thumbnails/4.jpg)
• Class I
• Class IIa
• Class IIb
• Class III
Risk classification of medical device
![Page 5: Regulatory Process for Medical Devices - Nemko Process... · European Regulatory regime Directives: •“Directive 90/385” means Council Directive 90/385/EEC of 20th June 1990](https://reader036.vdocuments.us/reader036/viewer/2022081723/5ac387407f8b9a57528c3357/html5/thumbnails/5.jpg)
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
![Page 6: Regulatory Process for Medical Devices - Nemko Process... · European Regulatory regime Directives: •“Directive 90/385” means Council Directive 90/385/EEC of 20th June 1990](https://reader036.vdocuments.us/reader036/viewer/2022081723/5ac387407f8b9a57528c3357/html5/thumbnails/6.jpg)
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
![Page 7: Regulatory Process for Medical Devices - Nemko Process... · European Regulatory regime Directives: •“Directive 90/385” means Council Directive 90/385/EEC of 20th June 1990](https://reader036.vdocuments.us/reader036/viewer/2022081723/5ac387407f8b9a57528c3357/html5/thumbnails/7.jpg)
• Basic Safety - Physical HAZARDS
• Essential Performance
• Risk Management Process
• Clinical Performance
• Manufacturer of Medical Device
Technical file content
![Page 8: Regulatory Process for Medical Devices - Nemko Process... · European Regulatory regime Directives: •“Directive 90/385” means Council Directive 90/385/EEC of 20th June 1990](https://reader036.vdocuments.us/reader036/viewer/2022081723/5ac387407f8b9a57528c3357/html5/thumbnails/8.jpg)
• 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
![Page 9: Regulatory Process for Medical Devices - Nemko Process... · European Regulatory regime Directives: •“Directive 90/385” means Council Directive 90/385/EEC of 20th June 1990](https://reader036.vdocuments.us/reader036/viewer/2022081723/5ac387407f8b9a57528c3357/html5/thumbnails/9.jpg)
Software
• Software used in Medical Devices
• Stand alone software inclusive
apps which meets the definition
of a medical device
![Page 10: Regulatory Process for Medical Devices - Nemko Process... · European Regulatory regime Directives: •“Directive 90/385” means Council Directive 90/385/EEC of 20th June 1990](https://reader036.vdocuments.us/reader036/viewer/2022081723/5ac387407f8b9a57528c3357/html5/thumbnails/10.jpg)
• Check the specifications from purchasers.
Assistance devices
![Page 11: Regulatory Process for Medical Devices - Nemko Process... · European Regulatory regime Directives: •“Directive 90/385” means Council Directive 90/385/EEC of 20th June 1990](https://reader036.vdocuments.us/reader036/viewer/2022081723/5ac387407f8b9a57528c3357/html5/thumbnails/11.jpg)
• 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
![Page 12: Regulatory Process for Medical Devices - Nemko Process... · European Regulatory regime Directives: •“Directive 90/385” means Council Directive 90/385/EEC of 20th June 1990](https://reader036.vdocuments.us/reader036/viewer/2022081723/5ac387407f8b9a57528c3357/html5/thumbnails/12.jpg)
• North-America
• Outside EU/EEA each country have their national
regulation/law for medical devices.
Markets outside EU/EEA
![Page 13: Regulatory Process for Medical Devices - Nemko Process... · European Regulatory regime Directives: •“Directive 90/385” means Council Directive 90/385/EEC of 20th June 1990](https://reader036.vdocuments.us/reader036/viewer/2022081723/5ac387407f8b9a57528c3357/html5/thumbnails/13.jpg)
Summary
![Page 14: Regulatory Process for Medical Devices - Nemko Process... · European Regulatory regime Directives: •“Directive 90/385” means Council Directive 90/385/EEC of 20th June 1990](https://reader036.vdocuments.us/reader036/viewer/2022081723/5ac387407f8b9a57528c3357/html5/thumbnails/14.jpg)
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