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Finalise the Product

NIC Document

Summary

Finalising your product is a demanding, but crucial stage in the innovation process. This guide provides an overview of the factors involved with preparing your product for CE marking or equivalent and specifies the main standards for each key area.

In Brief

  1. Finalise the design
  2. Risk assessment
  3. Design for manufacture
  4. Supply chain
  5. Sterilisation
  6. Packaging, labelling and IFUs
  7. Product testing
  8. FDA

Introduction

Finalising is a crucial stage in the development and preparation of a product for market. It is the phase that helps you to identify the potential risks and flaws in both your product and your supply chain. By addressing all the key areas, you can ensure that your innovation meets the stringent demands of the technical file so that it is ready for submission to a notified body for CE marking or equivalent.

Finalise the design

Finalising your design is an important commitment stage in developing your innovation. In developing a medical device, your designers will need to provide a technical file in order to obtain CE marking. The technical file is the culmination of the design process. When this is completed, your project is ready for submission to a notified body for CE marking (in Europe). In the technical file, which is governed by the Medical Device Directive, some of the requirements can only be confirmed on the finished product. The guide on ‘Regulatory Procedures for Medical Devices Under European Directives’ provides more information on the requirements of the technical file.

Risk assessment

Once you have finalised the design of your innovation, you will need to complete a detailed risk analysis. You should have undertaken a risk analysis at each stage of the design process and designed out any unacceptable risks in the final product. However, all remaining risks should be identified and eliminated to the point where they are acceptable to end users and notified and regulatory bodies.

Design for manufacture

Volume manufacture of any product usually makes more demands on the design than the initially developed design. An example of this is designing a product for injection moulding which requires a number of steps to ensure the device can be removed from the mould tool. This design process is called design for manufacture. By this stage, your designers should be aware of the most appropriate manufacturing methods for your product. A number of factors such as quality, piece part cost, reliability, time, set-up costs, and rejection rates will help your designers to decide on the most appropriate manufacturing methods. Particularly with innovative methods or materials, you may be limited as to the number of potential suppliers, which can affect costs, availability, and quality. You will have to supply the results of the tests that prove your claims for your device in the technical file. You must be able to demonstrate that these relate to your final designed product.

Supply chain

In finalising the design, you will also need to consider the supply chain you need order to produce and sell your device on a commercial basis. You need to address:

  • Cost: The cost of the parts that make up your medical device will have a direct impact on its final selling price and competitiveness.
  • Quality: Poor quality can affect the performance of the device which may cause serious health or reliability issues. It is advisable to choose a supplier who works to a quality management system such as ISO 13485 or ISO 9001 and regularly audit them to ensure that they maintain these standards. You must also make sure that any raw materials they use are of the quality defined in your final design specification.
  • Reliability: The reliability of your supplier is vitally important. If they are not able to deliver on time or provide consistent standard quality, they will affect your ability to provide a finished product. You should undertake regular audits of your suppliers wherever possible.

Sterilisation

Before a CE mark can be granted, it must be proved by an independent testing group that your device can be sterilised to the required standard for your device type. There are several groups within the UK that can perform these services and provide sterilisation services for your finished product prior to sale. The standards that relate to the sterilisation of medical devices are:
  • ISO 11138:2006 Parts 1-5 – Sterilisation of health care products; biological indicators (BI)
  • ISO 10993-7 Ethylene oxide sterilisation residuals
  • ISO 11135:2007 – Standard for ethylene oxide sterilisation
  • ISO 17665-1:2006 – Moist heat sterilisation
  • ISO 11137:2006 Parts 1-3 – Standard for gamma radiation sterilisation You can buy the relevant standards from BSI via their website: www.bsi-global.com

Packaging, labelling and IFUs

As well as finalising your design, you must ensure that your device arrives with the appropriate instructions. This information must be included in the technical file before the device will be granted a CE mark. Packaging: The packaging of a device is extremely important. As well as ensuring the device remains sterile, drop tests and transit tests must be performed with the results included in the technical file to ensure that the packaging is fit for purpose. There are also regulations regarding the labelling information which must be included on medical device packaging. The packaging regulations are covered by:

  • BS EN ISO 15378:2007 Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)
  • BS EN ISO 11607-1:2006 Packaging for terminally sterilised medical devices. Requirements for materials, sterile barrier systems and packaging systems • BS EN ISO 11607-2:2006 Packaging for terminally sterilised medical devices. Validation requirements for forming, sealing and assembly processes
  • BS EN 868-1:1997 Packaging materials and systems for medical devices which are to be sterilised

General requirements and test methods

Labelling: The design of your labelling is essential in reducing possible errors in use by your customers. There are regulated symbols that must be applied to medical devices according to the standards listed below. These are covered by:

  • BS EN 60601-1-9:2008 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Requirements for environmentally conscious design
  • BS EN 980:2008 Symbols for use in the labelling of medical devices
  • ISO 15223-1:2007 EDTN1 ISO 15223-1:2007 Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Part 1: General requirements (Revision of ISO 15223:2000/Amd 1:2002/Amd 2:2004
  • 08/30154605 DC BS ISO 15223-2. Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Part 2: Symbol development, selection and validation.

IFUs: Instructions for Use (IFUs) are required for inclusion with every medical device. The standards contain the information that should be included in the IFUs. You should ensure that they are in the appropriate language for the territories where the device is to be sold. For this reason, most IFUs are in multiple languages according to sales territories. Again, this information must be included in the technical file. It is covered by:

  • BS EN 1041:2008 Information supplied by the manufacturer of medical devices

Product testing

There is no definite guidance on the requirements for product testing for pre-CE registered medical devices. The standards on medical device testing are:

  • BS EN ISO 10993-1:2003 Biological evaluation of medical devices

Evaluation and testing

  • 08/30116059 DC BS ISO 14155. Clinical investigation of medical devices for human subjects

Good clinical practice

  • BS EN 60601-1-8:2007 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. Although clinical tests are not always required for CE marking, it is very likely that your product will not gain significant market acceptance until it is supported with clinical proof.

FDA

In the USA, the regulatory body in charge of medical device approval is the Food and Drug Administration (FDA). Although its approach is similar to CE marking in Europe, it is seen as undertaking a more rigorous and intensive process. There are many groups in the UK that can advise on the regulatory process required for the USA.