Jean-Louis Evans, Managing Director at TÜV SÜD Product Service and sister company, TÜV SÜD BABT discusses the implications of European device quality system standards and the potential issues effecting the industry
The current European medical device quality system standard is EN ISO 13485:2012, referred to as ‘ISO 13485:2003’, having replaced the previous harmonised standards EN ISO 13485:2000, EN ISO 13488:2000 and EN46003:1999.
‘ISO 13485:2003’ specifies “requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.”
As a management system standard for the regulatory compliance of medical device manufacturers and their service providers, all requirements of ‘ISO 13485:2003’ are specific to organisations providing medical devices, regardless of their type or size.
It is also not just medical products that are covered, but related services too. So, this standard will be something that the entire supply chain, including design houses, repair workshops and test laboratories, must consider.
The primary objective of ‘ISO 13485:2003’ is to facilitate harmonised medical device regulatory requirements for quality management systems, and it was recently revised in March 2012, harmonising it with the European Union’s Medical Devices Directive (93/42/EEC), the Active Implantable Medical Devices Directive (90/385/EEC) and the In Vitro Diagnostic Medical Devices Directive (98/79/EC).
This means that it includes some additional requirements for medical devices, while excluding some of the requirements of ISO 9001:2008 that are not appropriate regulatory requirements. Because of this, organisations whose quality management systems conform to ‘ISO 13485:2003’ cannot claim conformity to ISO 9001:2008, unless their quality management systems conform to all the requirements of ISO 9001:2008 as well.
However, if regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. It is the responsibility of the organisation to ensure that claims of conformity with ‘ISO 13485:2003’ reflect exclusion of design and development controls.
Going across a global scale
The certification of a quality management system, specifically for medical devices, to the ‘ISO 13485:2003’ standard proves advantageous, and in many cases essential, for medical companies which export their products to the global market.
In the European Union, the fulfilment of EU Directives (e.g., Active Implantable Medical Devices Directive, Medical Devices Directive and In Vitro Diagnostic Medical Devices Directive) allows the free trade of medical devices. Increasing numbers of medical device manufacturers and service providers are
therefore using ‘ISO 13485:2003’ certification in the regulatory and supplier approval process as it provides the first step in achieving compliance with European regulations.
It also delivers a structure to gain CE Marking so that the medical device can be sold throughout the EU. For service providers it gives an extra level of assurance to medical device manufacturers that the company has robust systems in place.
When manufacturers are active in the world market, the focus on global or international standards such as ISO is not only advantageous – it may be stipulated by certain countries.
Even where there is no specific legal requirement to hold ‘ISO 13485:2003’ certification, the regulatory agencies often use it as a basis not to visit suppliers of the legal manufacturer when issuing the regulatory certificate. In effect for those that do not belong to the ‘ISO 13485:2003’ ‘club’, market opportunities are shrinking without it.
Adherence to the standard also brings other benefits including customer satisfaction (although not a requirement of ‘ISO 13485:2003’), as products manufactured according to the standard should be of high quality, reliable and safe.
Planning for risk management
Adherence should also bring improved risk management, and reduce costs, as the continual improvement of processes increases efficiency and strengthens the process.
In Europe, all activities associated with the regulatory compliance of the product (all devices except class 1 self declared devices, custom made devices and devices for clinical investigations) must be reviewed by a Notified Body to receive the CE mark.
If the key supplier already has ‘ISO 13485:2003’, this may negate the need for a site visit from the Notified Body – saving the organisation time and cost.
Within the next few years, the European Medical Device Directives will become one or possibly two regulations. This has far reaching implications for all those products that must currently comply with one of the medical device directives.
The main implications of the change from directives to regulations will be:
Each EU country will have to implement the regulations word for word as written, thus minimising any differences in the way the system will operate across the EU.
There will be an immediate transposition of the regulations into the national legislation of each EU member state, although there will be a transition period which will allow companies time to adapt to some or all of the new requirements.
The proposed regulations (currently at the initial draft stage) include new industries for the first time such as the cosmetic surgery, cosmetic contact lenses and liposuction industries. While this implies far reaching consequences for the medical device supply chain, best practice advice would be to keep up to date on the planned changes to the Medical Device Directives and also ensure that ‘ISO 13485:2003’ is followed in your organisation.
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