A very regular industry

With new markets for medical devices offering potential for global growth, the need for quality controls and cross-industry standards has never been higher. Here, Claire Lynam of BSI explains why specialised expertise is vital for an industry dependant on quality

The market for medical devices – which covers a very wide range of products from bandages to artificial hearts – represent a substantial global business, worth over £200bn per year and growing rapidly. For obvious safety reasons, sales of medical devices are highly regulated and gaining approval for their sale and distribution can be a lengthy and complex process.
The medical device industry faces a complex global market place, affected by multiple regulatory systems, international and national standards and requirements. This complex environment is constantly changing and influenced by many national and international forums and initiatives, particularly the drive towards global harmonisation.
Medical devices first began to be regulated in the US 30 years ago, but it is only more recently that regulation has become widespread. In 1992, the European Community adopted its Conformité Européenne (CE) marking scheme which was applied to the industry, while Japan enacted the country’s Pharmaceutical Affairs Law (PAL).
In this context, BSI has spent recent years forging links with regulators around the world with a view to improving understanding and communication between manufacturers, regulators and healthcare authorities.
BSI Product Services, and other orgainations like them, help manufacturers understand what they need to do to place compliant devices into markets throughout the world. They are also positioned to interpret the global situation today and provide guidance on the emerging requirements and regulations.
BSI has been certifying and testing medical devices since 1979 when it was asked to set up a facility by the UK Department of Health. BSI are specialists in the fields of standards, testing, management systems registration and product certification. As a Notified Body, appointed by the EC’s healthcare regulators to provide CE marking, BSI supports manufacturers of novel and established devices. A broad portfolio of clients represents a comprehensive cross-section of the medical devices manufacturing industry and includes large multinational corporations and small venture companies.
The range of services offered has changed over the years to reflect the changing demands of this industry and the individual requirements of different countries around the world. Today, BSI product services - medical devices division - helps manufacturers get their products onto the international market place by taking them through the, often stringent, testing and certification processes necessary for Europe, USA, Canada, Taiwan, Japan and Australia.
The product certification procedure offers various routes for approval which are dictated by the risk posed by a device. BSI reviews product documentation and checks manufacturers’ claims, the accuracy of labels and the sterility of a product. There is a second process – quality auditing – which includes client visits and inspection of the production processes. Where necessary, BSI does offer product testing for medical devices such as with natural latex male condoms and surgeon’s rubber gloves, as well as electrical products such as dialysis machines and infusion pumps.
The certification and testing services that an external regulation specialist can offer in the medical devices industry include the following:
 Notified Body for CE marking under the Medical
 Devices and Active Implantable Medical Devices
 (AIMD) Directives.
 - CE marking under the In-vitro Diagnostic Medical
 Devices Directive, in conjunction with our Notified
 Body partner.
 - Assessment under the Canadian Medical Device
 Conformity Assessment System (CMDCAS).
 - Taiwan accelerated medical device registration.
 - US FDA 510(k) Reviews under the FDA (Food and
 Drugs Agency) third party approval programme.
 - Product testing capabilities.
 - Kitemark product certification.
 - Assessment and registration of quality management system
 registration to ISO13485.
 - Standards Council of Canada (SCC) and UKAS
 (UK Accreditation Service) Accreditation for ISO9001,
 ISO13485. 
 - Documentation evaluation.
 - Testing devices.
 - Providing access to information and standards.
 - Supplying relevant training.
 - Understanding regulatory requirements.

Certification processes involve analysis, review and reporting that lead to the, hopefully, successful award of the appropriate certificate. Only then can the manufacturer proceed to place his products in the appropriate international market. Often manufacturers need a helping hand through the sometimes, complex and involved process of international certification. In some cases this kind of specialised help can achieve a faster result than if manufacturers went direct to the local certification body.

Route to compliance – CE marking
Working with an experienced and recognised partner who can guide companies through the regulatory requirements brings confidence and many benefits to manufacturers who wish to access global markets.
Medical devices sold in Europe must be certified under the CE marking scheme which is strictly controlled for medical devices in the European Union. To be able to use CE marking, manufacturers may need to work with a Notified Body, who act on behalf of the European regulators, to demonstrate compliance with European regulations, but this depends on the type of device.
The medical devices team at BSI conducts conformity assessments against most of the allowable routes to CE marking covering quality assurance - full production or product oriented, type examination and product verification.

CE marking & Kitemark – what's the difference?
CE marking and Kitemark are not identical, but complementary. While CE marking is the minimum legal requirement for Europe, the Kitemark offers an additional programme of continual compliance monitoring.
BSI also owns the registered Kitemark and regularly carries out tests on products seeking this distinctive mark of quality. The Kitemark delivers credible assurance of product quality and consistency. Kitemark products in the medical devices field include surgeon’s rubber gloves, natural latex male condoms and creped/plain sterilisation paper for medical use.
The Kitemark for condoms complements the essential requirements stipulated in the European Medical Devices Directive. It provides reassurance by independent validation against pre-defined standards, sustained by repeated batch testing. For a product with such social and health implications and the consequences of their failure means they need to be consistently safe. Condom manufacturing is a very precise process where slight changes in production can have adverse effects. As such it is necessary to carry out a series of tests on all Kitemark condoms including:
l Strength tests, before and after ageing, to ensure mechanical
 resistance of the latex material and the finished product.
l Tests to detect holes, tears, foreign bodies and visible defects
 are conducted to ensure condoms deliver the required
 contraceptive protection and act as an efficient barrier against
 viruses and pathogenic agents.
l Test for colour fastness and checking minimum length and
 width stipulations.
l User instructions are tested for clarity.

BSI’s testing of condoms and the Kitemark award is supported by the Family Planning Association.
Worlds of experience
BSI is keen to become an authorised certifier in as many countries as possible, to provide a comprehensive service to multinational and small venture companies. Gaining product approval can be a lengthy business, especially if a company has to start from scratch for every market. BSI, and other similar services, act as an intermediary, speeding up the process. In some cases, approval for a new product can be obtained within five days, involving the exchange of a single letter but normally the time it takes to get approval depends on the type of product and the country where it will be marketed.
For example gaining regulatory approval in the Far East can be more time consuming than in other regions. By working as an authorised certifier within a number of different countries, BSI could provide a time saving bridge between manufacturers and regulatory bodies, providing cost and time savings while ensuring the highest possible standards.
BSI was first appointed as an authorised certification body for medical devices in Canada. Later, Australia and Taiwan were included. In Japan’s PAL scheme BSI has recently been appointed as one of 12 approved organisations for third-party reviews. BSI is also negotiating for recognition with seven other countries: Brazil, China, Hong Kong, Malaysia, Singapore and Thailand.
In such a complex industry, where an error in quality can literally mean the difference between life and death, it’s good to know that careful attention is being paid where it counts.

By Claire Lynham, BSI product services