On March 3rd join FX Conferences and Leo Eisner to learn about the home healthcare environment and the proposed emergency medical services standards, respectively IEC 60601-1-11 & IEC 60601-1-12 (hopefully).  More information can be found on our blog post on this topic.

On March 4th  join Leo Eisner in Foster City, CA as he & several other presenters focus on the topic of “Evolving Risk-Based Regulatory Requirements” for a whole day workshop put on by RAPS (SF Bay Area Chapter) & ASQ (Biomedical Division Northern CA Discussion Group).  Leo will be presenting on the 3rd ed. of IEC 60601-1, the series of standards, and also the impact of change on the medical device industry.  Other topics will include Usability & Human Factors verification, validation, and regulatory requirements; and Clinical evaluation & investigation regulatory requirements. More information can be found on our blog post on this topic.

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Summary:
This issue is packed full of important updates and useful information. First, we are going to focus on additional updates with regard to IEC/EN 60601-1:2005/2006 as there is significant news since the last issue of our newsletter.

Next we delve into the MDD Amendment 2007/47/EC specifically on the updated Classification MEDDEV and the new Clinical Data requirements. We also would like to remind you when your EU MDD Notified Body is up to reviewing your technical file or design dossier you need to make sure you have addressed the Usability and Clinical Data requirements as they apply to all medical devices under the MDD Amendments. If you need help with these new requirements to the MDD we have a toolkit that will be helpful to you.

Lastly, our Associate Christine Ruther writes about an FCC publication in regard to medical devices that use inductive coupling to recharge batteries.

We hope you enjoy this edition of the newsletter and we would enjoy hearing back from you on any suggested topics and your feedback.

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TÜV America Inc. announces that its registrar division, TÜV Management Service, has received accreditation from Standards Council of Canada (SCC) and Health Canada as a Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrar on August 8, 2001. CMDCAS recognition enables TÜV to perform accredited ISO 13485 / 13488 quality systems certification services for medical device manufacturers marketing their products in Canada through the Medical, Health and Sports division of TÜV Product Service. TÜV becomes the first registrar in the world to be CMDCAS recognized by Health Canada and the SCC to provide ISO 13485 / 13488 certification. Combined with TÜV Product Service’s full suite of medical services and status as the leading Notified Body for the EU Medical Devices Directive, clients can receive all their conformity assessment services from one leading organization.

To date, Health Canada is the first national regulatory body to require a specific quality systems standard, ISO 13485 / 88 as a prerequisite to device licensing requirements necessary to conduct business in Canada. Published on May 7, 1998 the device and establishment licensing requirements found in sections 43 and 44 of the Canadian MDR (Medical Device Regulations) came into force on January 1, 1998. The quality systems requirements found in sections 32 (2) (f), 3 (5) and 4 (p) due to come into effect July 1, 2001, have been amended and will now come into force eighteen months later on January 1, 2003. Beginning July 1, 2001, a voluntary transition period will begin for all manufacturers of applicable (class 2-4) medical devices in the Canadian marketplace to receive ISO 13485 / 88 by a CMDCAS recognized registrar (TÜV Management Service). As of January 1, 2003 manufacturers of class 2-4 medical devices not already in the Canadian market must submit an appropriate CMDCAS ISO 13485 / 88 quality system certificate to Health Canada along with their device license application. Annual renewal of the latter is required each November. Manufacturers whose class 2-4 devices are already licensed to market in Canada have until November 1, 2003 to submit appropriate CMDCAS ISO 13485 / 88 certificates with their renewal applications. (ISO 13485 and 13488:1996 are quality management standards specific to the medical device industry, which supplement ISO 9001 and ISO 9002:1994 quality management systems standards)

Canadian Requirements

To date, Health Canada is the first national regulatory body to require a specific quality systems standard, ISO 13485 / 88 as a prerequisite to device licensing requirements necessary to conduct business in Canada.

Manufacturers of Class 2 devices must comply with the requirements for ISO 13488 and manufacturers of Class 3 and 4 devices need to meet the requirements for ISO 13485. Accreditation to these standards must be achieved by a Health Canada recognized SCC accredited registrar. The SCC is deeming these registrars Canadian Medical Devices Conformity Assessment System (CMDCAS) registrars.

TÜV Management Service, the registrar division of TÜV America Inc., is the first registrar to receive accreditation by the SCC and Health Canada as a CMDCAS recognized registrar. This accreditation enables TÜV Management Service to provide clients ISO 13485 or ISO 13488 certification for medical device manufacturers selling their product in the Canadian marketplace. Combined with TÜV Product Service’s full suite of medical services and status as the leading Notified Body for the EU Medical Devices Directive, clients can receive all their conformity assessment services from one leading organization, TÜV Product Service.

About CMDCAS

Published May 7, 1998 the device and establishment licensing requirements found in sections 43 and 44 of the Canadian MDR (Medical Device Regulations) came into force on January 1, 1998. The quality systems requirements found in sections 32 (2) (f), 3 (5) and 4 (p) were due to come into effect July 1, 2001, have been amended and will now come into force eighteen months later on January 1, 2003. Beginning July 1, 2001, a voluntary transition period will begin for all manufacturers of applicable (class 2-4) medical devices in the Canadian marketplace to receive ISO 13485 / 88 by a CMDCAS recognized registrar (TÜV Management Service). As of January 1, 2003 manufacturers of class 2-4 medical devices not already on the Canadian market must submit an appropriate CMDCAS ISO 13485 / 88 quality system certificate to Health Canada along with their device license application. Annual renewal of the latter is required each November. Manufacturers whose class 2-4 devices are already licensed to market in Canada have until November 1, 2003 to submit appropriate CMDCAS ISO 13485 / 88 certificates with their renewal applications.