EU Interpretative Doc on Placing Med Dev’s on Mrkt

leoeisner — Wed, 01 Dec 2010 19:43:29 +0000

On 16 November 2010 this Interpretative Document was issued to explain what is considered Placing Medical Devices on the EU Market. The document refers to all 3 medical device directives including the amendment 2007/47/EC. The 3 medical device directives this applies to are Active Implantables Medical Devices 90/385/EEC, Medical Devices 93/42/EEC, and the InVitro Diagnostic Medical Devices 98/76/EC. Additionally, the biocidal products directive 98/8/EC is also referenced in this document.

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.

Joint FDA/FCC public mtg 7/26-27 – Enabling Convergence of Communication & Medical Systems

eisnersafety — Fri, 18 Jun 2010 18:27:23 +0000

Joint FDA/FCC public meeting July 26 & 27, 2010 – Enabling Convergence of Communication & Medical Systems: Update Regulatory & Info Processes http://ht.ly/20oMz

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

Medical Implants – Eisner Safety Consultants

EU Interpretative Doc on Placing Med Dev’s on Mrkt

Joint FDA/FCC public mtg 7/26-27 – Enabling Convergence of Communication & Medical Systems