This document refers to the EU Directive on accreditation and market surveillance relating to the marketing of products which is EC/765/2008.  EC/765/2008 is relied on for the term “making available’.

The interpretative document may be viewed by clicking EU Interpretative Document – Placing Medical Devices on the Market.

To see a list of the current EU Medical Device Directives Interpretative Documents you can go to the EUROPA webpage that has the Medical Device Directives Interpretative Documents.

The scope states, noting that all ALL CAPITAL words are defined either in this standard or other referenced standards:

“Recognizing that MEDICAL DEVICES are incorporated into IT-NETWORKS to achieve desirable benefits (for example, INTEROPERABILITY), this international standard defines the roles, responsibilities and activities that are necessary for RISK MANAGEMENT of IT-NETWORKS incorporating MEDICAL DEVICES to address SAFETY, EFFECTIVENESS and DATA AND SYSTEM SECURITY (the KEY PROPERTIES). This international standard does not specify acceptable RISK levels.

NOTE 1 The RISK MANAGEMENT activities described in this standard are derived from those in ISO 14971 [4]. The relationship between ISO 14971 and this standard is described in Annex A.

This standard applies after a MEDICAL DEVICE has been acquired by a RESPONSIBLE ORGANIZATION and is a candidate for incorporation into an IT-NETWORK.

NOTE 2 This standard does not cover pre-market RISK MANAGEMENT. This standard applies throughout the life cycle of IT-NETWORKS incorporating MEDICAL DEVICES.

NOTE3 The life cycle management activities described in this standard are very similar to those of ISO/IEC 20000-2 [10]. The relationship between ISO/IEC 20000-2 and this standard is described in Annex D.

This standard applies where there is no single MEDICAL DEVICE manufacturer assuming responsibility for addressing the KEY

PROPERTIES of the IT-NETWORK incorporating a MEDICAL DEVICE.

NOTE 4 If a single manufacturer specifies a complete MEDICAL DEVICE that includes a network, the installation or assembly of the MEDICAL DEVICE according to the manufacturer’s ACCOMPANYING DOCUMENTS is not subject to the provisions of this standard regardless of who installs or assembles the MEDICAL DEVICE.

NOTE 5 If a single manufacturer specifies a complete MEDICAL DEVICE that includes a network, additions to that MEDICAL DEVICE or modification of the configuration of that MEDICAL DEVICE, other than as specified by the manufacturer, is subject to the provisions of this standard.

This standard applies to RESPONSIBLE ORGANIZATIONS, MEDICAL DEVICE manufacturers and providers of other information technology for the purpose of RISK MANAGEMENT of an IT- NETWORK incorporating MEDICAL DEVICES as specified by the RESPONSIBLE ORGANIZATION.

This standard does not apply to personal use applications where the patient, OPERATOR and RESPONSIBLE ORGANIZATION are one and the same person.

NOTE 6 In cases where a MEDICAL DEVICE is used at home under the supervision or instruction of the provider, that provider is deemed to be the RESPONSIBLE ORGANIZATION. Personal use where the patient acquires and uses a MEDICAL DEVICE without the supervision or instruction of a provider is out of scope of this standard.

This standard does not address regulatory or legal requirements.“

The information on this page is based from IEC webstore for IEC 80001-1, 1st ed.

Summary:  The FDA and the FCC are jointly sponsoring a public meeting entitled “Enabling the Convergence of Communications and Medical Systems: Ways to Update Regulatory and Information Processes.”The purpose of this meeting is to identify the challenges and risks posed by the proliferation of new sophisticated medical implants and other devices that utilize radio communications to effectuate their function, as well as challenges and risks posed by the development and integration of broadband communications technology with healthcare devices and applications.

Dates and Times: The public meeting is scheduled for July 26 and 27, 2010, from 8 a.m. to 5:30 p.m. Persons interested in attending and/ or participating in the meeting must register by 5 p.m. EDT on July 19, 2010. Submit either electronic or written comments related to the agenda, by 5 p.m. EDT on June 25, 2010.

Location: The public meeting will be held at the FCC Commission Meeting Room, 445 12th St. SW., Washington, DC 20554

Contact Persons: Bakul Patel, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, rm. 3543, Silver Spring, MD 20993, 301-796-5528, email: bakul.patel@fda.hhs.gov; or Bruce Romano, Federal Communications Commission, 445 12th St. SW., rm. 7-C140, Washington, DC 20554, 202-418-2470, email: bruce.romano@fcc.gov.

Registration and Requests for Oral Presentations: Registration requests must be received by 5 p.m. EDT on July 19, 2010. Interested persons may register by emailing FCC-FDAMeeting@fcc.gov