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Did you know - that you had a role to play in the CE Marking of medical devices?

Did you know - that you had a role to play in the CE Marking of medical devices?

(OnTarget. Vol 4, issue 6 2005)

You probably thought that the responsibility for complying with the UK Medical Device Regulations lay principally with your Company’s management through the activities of its’ Technical, Regulatory, Quality, Clinical and Production Departments.

You are quite right in that understanding; however that is not the whole story. Would it surprise you to learn that you have an important role to play and a contribution to make in maintaining that compliance?

The UK Medical Device Regulations call for the monitoring of the performance of medical devices in clinical use. A term that is currently used to describe this action is “post-market surveillance”. The clause in the Regulations that covers this requirement states that manufacturers must “institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase and to implement appropriate means to apply any corrective action”. This is “postmarket surveillance” or PMS for short.

The contribution that you can, and should, make to the maintenance of compliance with the Regulations is covered under postmarket surveillance.

In the course of your work you will be visiting clinical areas in the region for which you are responsible. This could include hospital wards, perioperative clinical areas, primary health care locations, nursing homes and patient’s homes, etc.

During those visits you may well be observing the clinical use of the medical devices that you are promoting and supporting. With good design there should not be any problems in the use of your products. On the other hand you may observe some concerns or problems in such use.

It is important that you report your observations to your Company, and it would be prudent for you to make a dated record that you have done so. Some Companies already have established a routine by which their field staff can regularly report such observations to them.

In the unfortunate situation of an enquiry resulting from a problem in use with your medical device then your documented reports would provide a desirable personal defence. Some examples of situations that would qualify for PMS reporting are as follows:

¦ problems in opening the package (particularly significant for sterile devices)
¦ problems in assembly or preparation
¦ problems in use
¦ use of a device for a purpose other than that for which it was designed
¦ inadequate, ambiguous, or misleading labels and/or instructions for use
¦ reuse or multiple use of a single-use device.

On receipt of your observations the Company would then review them and take the appropriate action which could be one of several:

¦ review and change the design under principles of good quality management,


¦ revise the labelling and/or instructions for use,
¦ reinforce the designed and intended use of the device in more precise and emphatic labelling and instructions for use, and possibly by other educational methods,
¦ consider the retraining of clinical staff in the use of their device.

These actions would result in an improved design and/or a better understanding in their use with the objectives of improvements in clinical benefit, patient and user safety, enhanced reputation of the Company, and protected or increased sales.

This PMS feed-back of information to your Company’s management is the part that you can play in helping to maintain their compliance with the Regulations.

A brief summary of the Regulations is set out below.

The UK Medical Device Regulations are the transposition of three EC Medical Device Directives and their amendments and complementary Directives. These are the Directives for Active Implantable Medical Devices1, for Medical Devices2, and for In Vitro Diagnostic Medical Devices3. The Medical Devices Directive was amended by two Directives to include stable derivatives of human blood or plasma4, and complemented by two further Directives, for the reclassification of breast implants5, and to cover medical devices utilising tissues of animal origin6.

The Medical Devices Directive was initially transposed into UK Law under the Consumer Protection Act as Statutory Instrument (SI 1994:3017). This SI was superseded by The Medical Devices Regulations 2002 (SI 2002:618), and by The Medical Devices (Amendment) Regulations 2003 (SI 2003:1697). These two current SIs incorporate all the three EC Directives, their amendments and complementary Directives and other relevant administrative UK legislation.

The UK agency for overseeing compliance with the Regulations is the Medicines and Healthcare Products Regulatory Agency7 (MHRA). It is an Agency within the UK Department of Health. A British based company that manufactures medical devices has to review the UK Regulations, design them to comply, and sign a statement that the medical device meets all of the essential requirements that apply to it. The “essential requirements” are fully described in the Regulations. The medical devices must be designed to ensure and demonstrate that they are safe for patients and users for their intended purpose. The Company must have a quality system, undertake a risk analysis for the product, and have justifiable clinical evidence for its use. Compliance with the regulations then requires the display of the CE Mark on the product or its’ labelling, and in the instructions for use; and this provides freedom of trade within the European Union.

Product design is generally a “dynamic” process and is not a static condition. Design review is an important element in an effective Quality System. Design changes and improvements rely on intelligent observations, customer feedback, product complaints and other sources of information, and this includes the observations that you have in the use of your products which you feed back to your Company. These concepts equally apply to medical devices. The Medical Device Regulations also cover the reporting requirements of Medical Device Vigilance. These deal with the reporting of adverse incidents arising in the use of a medical device. Adverse incidents are described as those causing death or serious injury and hence are obvious candidates for design review or other action.

I R Cutler
BSc, FIQA, FTOPRA
Theatre Skills Training Faculty


References 1 The Active Implantable Medical Devices Directive: 90/385/EEC
2 The Medical Devices Directive: 93/42/EEC
3 The In Vitro Diagnostic Medical Devices Directive: 98/79/EC
4 EC Directives 2000/70/EC and 2001/104/EC: medical devices incorporating stable derivatives of human blood or plasma
5 EC Directive 2003/12/EC: reclassification of breast implants
6 EC Directive 2003/32/EC: medical devices utilising tissues of animal origin
7 The UK Medicines and Healthcare Products Regulatory Agency – MHRA www.mhra.gov.uk
8 The European Commission www.europa.eu.int
9 The Directorate General within the EC that deals with medical devices is DG Enterprise: 1 http://europa.eu.int/comm/enterprise/medical_devices

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