Brandwood Biomedical Newsletter March 2008

Welcome to the first Brandwood Biomedical newsletter for 2008. We start the New Year with some exciting new developments for the company, and a range of developments in the regulatory world.

We’ve moved to Sydney!

We are pleased to announce the relocation of the head office to Sydney. The new location in St Leonards allows us to be more accessible to clients and to create a great base for operations in one of the major medical technology hubs of Australia.

Our new address is just minutes from the Sydney CBD at

Suite 408/460 Pacific Highway , St Leonards, NSW 2065.

Click here for full contact details

A growing team

The New Year has seen the company not only relocate, but grow in size with long standing team members Joshua Griffin and Joy Woods now joining the company full-time. Both Joy and Josh are qualified biomedical engineers and will continue to contribute to client projects particularly in quality systems, technical file development and advertising controls.

We also welcome a new member to the team, Kevin Badin. Kevin brings a wealth of experience in implementing, auditing and managing quality management systems, project engineering, product development, documentation and manufacturing. Kevin joined the Australian medical device industry in the early ‘90s as a manufacturing engineer with Telectronics and since worked with many of Australia’s best known research based companies, assisting them to achieve certification to ISO13485:2003 and ISO 9001:2000. His qualifications include project management, industrial engineering, workplace safety and assessment (OH&S), workplace training and internal auditing. 

European MDD changes

Perhaps the most significant change to the regulatory landscape in the past few months has been the updating of the European Medical Device Directive (MDD). This represents the first major change to the directive since 1993 and all medical device manufacturers exporting to Europe must understand how these changes will affect them. Transitional arrangements apply to March 2010 by which time all suppliers must comply with the new requirements. The following are some of the more significant changes to the Directive

Clinical Evidence

Of particular importance is the tightening of the clinical evidence requirements. Although always an implied requirement, compliance with clinical evidence requirements has not been uniform. The new text makes it very clear that all medical devices require full clinical evidence to be documented before placing on the market. (Incidentally, other jurisdictions, not least Australia’s TGA are taking a much firmer line on Clinical Evidence, with clinical evidence likely to receive greater attention in postmarket audits).

Software is an Active Device, requires life cycle management

Software is now expressly considered an active device. This was previously expressed in guidance, but the Annex IX definition of Active Medical Device has been amended to expressly include software. This is likely to result in the up-classification of a number of devices previously regarded as Class I, particularly involving diagnostic software, which is now clearly considered “active devices for diagnosis – classified as IIa under classification rules.

Software validation requirements have been clarified somewhat with new Essential Requirement 12.1a requiring software to be “validated according to the state of the art, taking into account the principles of development lifecycle, risk management, validation and verification. Note particularly the reference to life cycle management – which is the subject of EN 62304:2006 Medical device software. Software life-cycle processes.

Sitting on the fence?

In a significant alteration to the directives, a revised definition at Article 1 5(c) expressly states that the test of whether a product is a drug or device will be the primary mode of action rather than the manufacturer’s stated Intended Purpose. This may result in the shift of a number of borderline products from regulation as devices to regulation as medicines or vice versa.

Don’t forget about your post-market responsibilities

Competent Authorities have increasingly stressed the importance of post-market surveillance systems. The Directive text has been updated throughout to expressly require implementation of postmarket systems, irrespective of device class or means of conformity assessment. This requirement has also been extended to manufacturers of custom made medical devices.

The full consolidated text is available from the Europa website.

FDA user fees trimmed

In the USA, the Medical Device User Fee and Modernisation Act II was recently passed which has reduced the cost of the regulator review process. The legislation however, also introduces both a device registration fee and an annual reporting fee.

FDA to extend small business concessions for non US companies

Small business concessions for US user fees have till now been out of reach of most Australian companies, as a US tax return is required to establish small business status. However following pressure from some overseas governments the FDA is proposing to extend the concession to companies who can establish small business certification based on national taxation authority (i.e. ATO) certification. The table below outlines the revised costs for small businesses (sales <US$ 100 million).

	2007	2008	2009
PMA Application	107 008	46 250	50 181
510 (k)	3326	1702	1847
Device Registration	-	1706	1851
Annual Reporting Fee	-	1619	1756

All amounts in US$

ISO 13485 and CE: Notified Bodies vs Registrars

We are often asked if an ISO 13485 certification should be obtained from a Notified Body or another Registrar. There is still an air of mystery regarding the difference between notified bodies and registrars but the difference is important to distinguish if you are planning to crack the European market. Notified bodies (and the Australian TGA) are authorised to perform audits and issue the CE Mark according to the applicable standards and Medical Device Directives. Registrars are authorized to audit compliance and can issue an ISO13485 certificate. However they are not able issue a CE certificate based on audit of the Technical File. A registrar may in some cases be a more appropriate and lower cost alternative for component suppliers or sub contract manufacturers, but for those intending to supply devices direct to Europe, using a Notified Body is essential.

TGA signs MOU with Canada

In a long awaited development, the Australian TGA has signed a Memorandum with Health Canada which will lead to mutual recognition of medical devices GMP audits between he two countries. For Australian suppliers this is a significant development in that it now allows the choice of TGA as an assessor for Europe and Canada, as well as Australia. A License application to health Canada, with a Technical File review for higher classification devices would still be required, but the on site inspections would be conducted by TGA, usually in conjunction with the Australian/European audits.

Medical Device Training

Brandwood Biomedical works closely with a sister company Perficio Pty Ltd (www.perficio.com.au). In particular Perficio offers extensive clinical trial support and training in all aspects of medical device regulatory affairs. For more details see http://www.perficio.com.au/training.htm

Upcoming Events

Brandwood Biomedical will be at both the NZBio conference from March 31^st to April 2^nd 2008 and the AusMedtech meeting in Sydney on 12^th and 13^th May. Dr Arthur Brandwood will be speaking at both conferences on global regulatory affairs and will be conducting workshops at both meetings. Please visit www.nzbio.org.nz/conference2008 and www.ausmedtech08.com.au for further details.

If you would like to take the opportunity to speak to us at either of these meetings please get in touch with us here .