Medical Newsletter

TÜV Product Service Medical Testing Times : September 2008

This is the third edition of the 2008 ‘Medical Testing Times’ from TÜV Product Service. This newsletter is designed to keep you informed about changes within the industry – updates to requirements, new services we offer, events we are exhibiting at and other relevant news. For more information on any of the stories please email us at: info@tuvps.co.uk

Upcoming changes to ISO 9001

ISO 9001: 2008 is expected to be published in November following a review by many of the stakeholders who use this standard. All standards come up from a review approximately every five years to see if they are meeting their intended purpose and to keep them up-to-date. The International Standards Organisation have only made minor changes compared to the major overhaul of the 1994 version that resulted in the “process approach” standard being first introduced in 2000. This review:

• Provides greater clarity and ease of use

• Incorporates improvements to address the interpretations and clarifications requested through the official interpretations process

• Improves compatibility with ISO 14001: 2004 for companies with both quality and environmental management systems certification

There are:

• No new or revised requirements

• No changes / modifications in existing requirements

• No increased or reduced requirements

• No change in intent of current requirements

The transition period for the 2008 version of the standard is 24 months so that there is no need for companies to change to this version before their normal three-yearly re-certification. A more comprehensive “revision” as opposed to this “review” is expected in 2015.

Reminder on changes to vigilance MEDDEV

The MEDDEV guidance document on a medical devices vigilance system was revised April 2007 (2.12-1 revision 5). The MEDDEV guidance documents are published by the European Commission (who wrote the Medical Devices Directives) and therefore have a high standing, despite being only guidance rather than legal documents. Although MEDDEVs are published as guidance, they may be incorporated into national laws and therefore end up being regulatory requirements. Medical device manufacturers therefore need to keep up-to-date with revisions and transpositions of these documents.

This revision introduces a number of new concepts and terminology including the terms Serious Public Health Threat, Field Safety Corrective Action and Field Safety Notice. The concepts of “incident” and “near incident” have been replaced by just the term “incident”, which is an “event” where the medical device is suspected to be a contributory factor that either led, or might have led to death or a serious deterioration in state of health.

Reporting is required for any “incident” with the device regardless of whether it killed the patient, caused serious injury or if either of these outcomes did not occur, but could have done. “Use Errors” are reportable only if they resulted in death or serious injury but are not reportable if these two outcomes did not actually occur. “Abnormal Use” is not reportable regardless of the outcome. Abnormal Use is where the medical device was not used as intended as a result of conduct beyond any means of risk control by the legal manufacturer.

The reporting timescale guidelines now include the new concept of a “Serious Public Health Threat” and these are required to be reported immediately (without delay that could not be justified) but no later than two calendar days. Death or unanticipated serious deterioration in state of health requires immediate reporting after the manufacturer has establishes a link between the device and the event (but no later than ten calendar days from becoming aware of the event). Other incidents require immediate reporting (but no later than 30 calendar days from becoming aware of the event).

PLEASE NOTE: This is a brief overview and the official text should always be referenced. See

http://www.tuvps.co.uk/uploads/images/1222766666749911900282/VIGILANCE_MEDDEV_2_12_1-rev_5-2007-fin2.pdf

Re-issue of ISO 13485 Certificates and Extension of EC Certificates

Replacing expiring certificates requires forward planning to ensure that new versions are not issued after the previous ones have expired. Quality System certificates (such as ISO 13485) are issued with a three-year validity and EC certificates with a five-year validity.

The ISO 13485 certificate is replaced following a successful Re-Certification Audit (Repeat Audit) and subsequent approval of the audit records by the Certification Panel. Please note that the Re-Certification Audit is normally planned 2-3 months prior to the expiry date to give sufficient time for any Non-conformity to be corrected (and for corrective action to be taken) as well as to give the Certification Panel time to review and approve the file. The recent changes to the ISO 17021 standard (affecting the audit process) requires that corrections and corrective actions to be provided for both Non-Conformities (NC) and Minor Non-Conformities (MNC).

The EC Certificate is “extended” for a further five years following submission of an EC Application for extension of the certificate (TÜV PS document number MED_F_03.10). This should be planned by the manufacturer at least SIX MONTHS before the expiry of the certificate and requires a number of different attachments depending on whether it is a quality system based certificate (e.g. Medical Devices Directive annex II.3, V.3 or VI.3) or a product certificate (e.g. Medical Devices Directive annex II.4 or III). See TÜV Product Service “MedInfo” guidance document at the following link

http://www.tuvps.co.uk/uploads/images/1223478108921298780083/Medical%20-10%20MedInfo.pdf

Upcoming Events

• Medica, Dusseldorf 19-22 November – TÜV SÜD Product Services will have a large stand at the world’s leading medical device exhibition again this year. Norman Richardson from our UK office along with colleagues from several other offices will be present to answer your questions about medical device regulation and certification. Come and visit us at stand C04 in Hall 10. Further details of Medica can be found by searching for “TUEV” under exhibitors at http://www.medica.de/

• Informa, Brussels 27/28 January – Norman Richardson will be speaking alongside other leading figures from the medical devices industry at the Informa Conference on “Managing the Revisions to the Medical Device Directive”. Norman’s presentation will cover “Evaluating conformity assessment changes”. Further details can be found at the following Informa link: http://www.iir-events.com/IIR-conf/LifeSciences/EventView.aspx?EventID=1938

Past Events

• Medtec Ireland, Galway 24-25 September – Norman Richardson spoke on “Changing Conformity Assessment Requirements for the MDD” on the first day of the Medtec Ireland conference in Galway. This event was well attended and the conference sessions proved to be very popular.

Useful Links

Standards Harmonised against the Medical Devices Directive:

http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html

Guidance documents from the European Commission:

http://europa.eu.int/comm/enterprise/medical_devices/index_en.htm

Global Harmonisation Taskforce guidance documents:

http://ghtf.org

TÜV Product Service Ltd medical device “MedInfo” guidance documents:

http://www.tuvps.co.uk/home_en/industries/medical_health/med-info_guidance_documents