Australian Third Party Assessment back on the Table...

At the end of last year, the TGA released a consultation paper on the use of Third Party Conformity Assessments for medical devices in Australia.

Currently, the TGA is the only Conformity Assessment Body for Australian manufacturers of medical devices. Industry has long been calling for the introduction of third party assessment for medical devices, a view echoed by the 2006 Australian Productivity Commission Banks Review. For detailed information on the benefits of third party assessment and international practices see this paper prepared for Ausbiotech as part of TGA consultations on 3^rd Party Assessment.

The consultation paper poses questions relating to the responsibilities and roles that should be given to the TGA as the medical device regulatory authority and to a third party assessor.  The paper outlines various factors that would need to be considered, including the class and material composition of the device. TGA are now seeking input on using third party assessment and what role they should have in the assessment and approval processes. Submissions are being accepted until Friday 27 March 2009. TGA is also holding free workshops open for all interested in voicing and sharing perspectives. These workshops are to be held on Tuesday 17^th March in Sydney and Wednesday 18^th March in Melbourne.

Click here to read the consultation paper and to submit your comments and input.

New TGA IVD Regulations to start this year

At the end of February, TGA published its proposed new regulations for In Vitro Diagnostic Devices (IVDs). These regulations follow the overall approach of the European IVD directive. However there are differences in the detailed classification rules and the regulations also include “in house” IVDs developed within a laboratory or laboratory network and are not supplied in a commercial context. TGA has teamed with NATA for the regulation of these “in house tests”

We will be publishing a more detailed review of the new regulations shortly. Meanwhile the following are key points to note.

• A new set of Australian classification rules which broadly follow the European approach but with some important differences in detail.
• A new national database for notification of “in house” tests to TGA. This will be combined with cross checking with NATA audits to confirm that pathology and hospital labs have notified tests to TGA and that NATA has certified all tests on the TGA database.
• The current proposal has TGA as the monopoly authority for regulation of Australian IVD manufacturers. This is of concern in context of current moves to introduce 3^rd Party assessment for medical devices in Australia.
• A total ban on any home use device intended to test for pathogens, notifiable diseases or serious disorders or determine genetic traits
• Clinical trial arrangements will be essentially as apply to medical devices.
• Postmarket “vigilance” arrangements will apply and a postmarket surveillance regime including TGA sampling and testing.

See the TGA consultation document here.

Significant Confusion over Significant Change

In all major jurisdictions, a significant change to a medical device design or to a manufacturing process triggers additional regulatory review. Identification of a significant change and when it’s necessary to notify a regulator can be perplexing at the very least. To complicate things, a change which is considered significant in one product may not be considered significant in another, due to differences in intended use, classification and other factors.

In general terms, a significant change is one which introduces a new design feature, intended purpose or production process and which alters the risk profile. Examples include:

• Any change to manufacturing process, facility or equipment used for the device, affecting the risk of the product. This includes any change to a “special” process which requires revallidation. For example, the addition of a new subcontractor for the “special process” of ethylene oxide sterilisation requires validation of the process and the subcontractor. On the other hand, a new supplier of straightforward components or materials with well defined specifications would not usually be considered a significant change.
• Some changes to manufacturing quality control procedures, including introduction of new methods for testing of quality and sterility of materials and the device.
• A significant design change can include a change in a component material of the product to improve performance which requires new clinical testing to confirm safety and efficacy of the product. A change in design for aesthetic reasons is not considered a significant change.
• Any changes to theintended use of the device, including new or additional uses, removal of uses or changes to shelf life.

Changes to a revised EU Medical Device Directive, which are to take effect in March 2010, include that even one significant change to a product after receipt of CE approval requires that product to undergo the approval process again. The European Notified Bodies association has released guidance for manufacturers, “Reporting of design changes and changes of the Quality System”. In Canada the manufacturer is required to have a procedure in place to identify a significant change and for amending a license in the event of a significant change for Class III or IV devices. Also available are a Canadian Guidance for the Interpretation of Significant Change and an FDA guidance to help with deciding when to submit a 510(k) for a change to an existing device. Still confused? Contact us for advice – we can advise you in determining if changes are significant and assist communications with regulators regarding the change.

Electronic Medical Devices to face harsher laws in Europe

For those marketing electronic medical devices in Europe, even more stringent laws may be faced in the near future.

The European Commission are currently drafting a revised Waste Electrical and Electronic Equipment (WEEE) Directive and Restriction of Hazardous Substances (ROHS) Directive to work towards meeting higher targets for the collection and recycling of waste electricals.

ROHS, introduced in July 2006, regulates the levels of hazardous substances in electrical and electronic products, while the WEEE Directive, first issued in June 2003, provides regulation for the treatment, recovery and recycling of electric and electronic equipment.

Before the revisions, medical devices and monitoring & control instruments were excluded from the scope of the ROHS Directive. The draft revision now covers both categories, so will apply to these products. In this context, medical devices include in vitro diagnostics, but not active implantable medical devices. Provisions for the inclusion of active implantable medical devices will be reviewed by 2020. The proposed revisions for the WEEE Directive include an annual waste collection target rate of 65% of the average amount of electrical and electronic equipment put on the market in the two preceding years.

Changes to both the ROHS and WEEE are in response to studies which have found less than half the electrical waste collected in the EU is subsequently treated and target levels are being increased to meet expectations in terms of protecting the environment and health.

and continuing on environmental matters...

Europe REACHing for Greener Solutions

Closely related to ROHS and WEEE is REACH, the Registration, Evaluation, Authorisation & Restriction of CHemical substances. REACH is a relatively new European regulation, introduced in June 2007 and addresses the management of risks associated with the production and use of chemical substances. The regulation aims to improve protection of human health and the environment against potentially harmful chemicals. REACH is also involved in promoting “green chemicals” and encourages manufacturers to work towards the gradual replacement of unsafe chemicals with safer, greener chemicals.

The regulation affects all manufacturers and importers of chemical substances, mixtures of chemical substances or chemical substances that make up an article. Medical devices affected by REACH range from dental filling materials and bone cements to catheters and pace makers. Any chemical substance used in a medical device which is not registered with the EU will need to go through an extensive registration process, requiring detailed technical data and results of testing for the safety of its use.

A number of REACH Annexes, which include technical guidances, are currently being reviewed. More information about REACH can be found on the European Chemicals Agency (ECHA) website.

Worried about compliance with European environmental regulations? Contact us for advice on how these changes may affect your business.

Are you in control of your suppliers...

This month the Global Harmonisation Task Force (GHTF) Study Group 3 released the final guidance on Control of Products and Services Obtained from Suppliers. The document is part of a series that cover quality management systems and describes the various controls that are to be exercised over the products and services of suppliers. The GHTF guidance details the responsibilities of the manufacturer to control its suppliers and vendors. Click here to view the GHTF document.

Manufacturer control over the supplier is addressed in Section 7.4.1 of ISO13485:2003 and Sec. 820.50 (a)(1) of 21CFR820, which require the manufacturer to exercise the right amount of control over the supplier based on the criticality and effect of the supplied product to the quality of the final product. By defining the risk associated with the supplied product, the correct level and type of control can be exercised. Multiple options exist, including vendor on site audits, incoming inspection processes, mandatory testing to your specifications at the supplier, and supplier certification.

At Brandwood Biomedical we can help you understand what methods of control are suitable for your needs and provide direct assistance with supplier controls, including conduct of on site vendor audits on your behalf. Contact us to discuss your needs.

Paul Cohen joins Brandwood Biomedical

Brandwood Biomedical is delighted to announce that Paul Cohen has joined us as Senior Consultant. Paul comes to us with a wealth of experience, including 15 years in the diagnostics industry, plus senior roles in pharmaceutical and medical device regulatory affairs. Paul has particular expertise in clinical trials management and in product development of high risk implantables. See Paul's full profile

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AusMedtech Conference 2009

Brandwood Biomedical is proud to be supporting the 2009 AusMedtech National Medical Technology Conference to be held in Sydney on 15th and 16th June. This is the premier national event for medical devices and diagnostics. The exciting and relevant programme provides many opportunities to learn and to network with industry colleagues. Some highlights include the latest developments on the new TGA IVD regulations and proposals for introduction of 3rd Party conformity assessment in Australia. Don’t miss the opportunities to build your strategies and networks for a successful business through the wealth of information and experience offered by some of the leading individuals and businesses of the international industry.

Want to talk? Just drop by our stand at the conference exhibition where we would be delighted to meet you – or please contact us if you wish to arrange a specific meeting.