PRESS RELEASE
February 16, 1995
Compulsory certification
for medical products
Swedish company among the first

From the beginning of the year, a new Directive for medical products has come into force in the EU. A Swedish company, Gibeck Respiration AB, is among the first to be certified within the system. Until now there have been legal requirements in some countries but not in others, and there is considerable variation between different countries.

Harmonisation of the medical industry moves forward with the introduction of the ‘Medical Devices Directive' (93/42/EEC). It applies from 1 January 1995, and becomes an absolute requirement on 14 June 1998. In the transition period (1995 - 98), both systems will run in parallel.
The new system requires manufacturers to mark their products with CE-marks. A risk classification of medical products is contained in the directive.
There are four main classes (I, IIa, IIb, and III), I being the lowest class of risk. Class I products which do not need to be sterile may carry CE-marks without a Notified Body issuing the certification. However, sterile Class I products, and products of Classes IIa, IIb, and III, must pass the scrutiny of a Notified Body. This type of organisation must itself have been approved, which not many have been so far. The British Standards Institution (BSI) became approved in September 1994.
‘Procedures for assessment of conformity', as the CE certification requires prescribes among other things that companies in an accessible and sufficiently defined way shall provide information regarding products, production, and other matters for scrutiny by a Notified Body or supervision by authority (Competent Authority).
To minimise the risks with a product, the concept of ‘essential requirements' has been introduced. These requirements are meant to introduce safety thinking in the early stage of product design. Additionally, a mode of thinking is introduced, where risks are weighed against intended efficiency and performance.

Swedish company takes lead

Since 9th December -- almost a month before the new directive took effect -- the Swedish company Gibeck Respiration AB was CE certified by the BSI for production of heat/moisture exchangers, bacterial/viral filters, and combinations of these, as well as for breathing masks and accessories for all products.
The company contacted BSI as early as March 1994, a good half-year before BSI itself became approved for issuing CE certification. Work towards certification began in 1993, having been decided on the previous year, and has since proceeded in stages. Since certification applies to most functions of a company, the work was allowed to permeate the whole company. The management group therefore became the steering group, a condition for success, as explained by Quality Manager Kristina Strohmayer.
‘It is important to have everything decentralised because everyone must know their part in the daily work and at the same time be prepared for the Notified Body to come back and check that the required quality system has been followed. Every member of the management group became a partial project leader and in Spring 1993 our management group went through special training', Strohmayer said.
In November 1994, assessment for certification was carried out, and at the same time the company received ISO 9001 certification.
The routines for the production are based on those from GMP. ‘The main contribution is closer control measures to ensure that the system is efficient. This allows the possibility of earlier detection if something is about to go wrong', said Strohmayer. ‘We also hope that CE Certification will mean a wider market because of the company's improved quality image'.
It is probable that Gibeck is the first company in the medical technology area to receive CE Certification. Siv Asplund Peiro, at the Medical Products Agency in Sweden (Läkemedelsverket), says that Gibeck was first in Sweden to update their register with CE certifications at the beginning of the year.
The National Board of Health and Welfare in Sweden (Socialstyrelsen) is of the opinion that Swedish medical technology companies are further forward in this respect than those of other European countries.
‘CE Certification will presumably become a condition for survival in the future', says Göran Liedström, responsible for medical products at the Board. ‘Medical products require that their quality is well documented. It is also good for the company's own climate that everything is audited by independent people. This usually leads to a better functioning organisation'.


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Picture 1: CE Mark
Picture 2: Kristina Strohmayer, Quality Manager

For further information:
Gibeck Respiration AB
Kristina Strohmayer
Box 711
S-194 27 Upplands Väsby
Sweden
Tel: +46 8 590 941 65
Fax: +46 8 590 705 55


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