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

geirolav.wang@nemko.com, phone: +47 928 014 66

• Denmark: Morten Hougaard:

morten.hougaard@nemko.com, phone: +45 222 002 45

• Sweden: Jens Bryntesson:

jens.bryntesson@nemko.com, phone: +46 708 11 97 17

Contact and Questions