Firstly the manufacturer needs to consider that the product falls within the scope of the Directive.
The European Commission has prepared some useful guidance in this area (MEDDEV 2.1/1) on the Europa website.
The manufacturer's products must meet all of the relevant Essential requirements contained in Annex 1 of the Directive. This will included amongst others, as relevant:
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Risk management
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Clinical data
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Sterilization
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Biological safety
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Electrical safety
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Electromagnetic compatibility
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Labelling and instructions
Where available relevant standards may be used to demonstrate how many of the requirements have been met.
In addition guidance on the Evaluation of Clinical Data (MEDDEV 2.1/1) may be particularly useful, and can also be found on the Europa website.
Manufacturers will also need to determine the classification of their products. Once this has been determined they will need to follow the appropriate conformity assessment procedure. This may require them to have their quality systems and technical documentation reviewed by a Notified Body before they can place their products on the market. The body will need to assure itself that relevant requirements have been met before issuing relevant certification. Manufacturers can then place the CE marking on their products to demonstrate ther compliance with the requirements.
MHRA has produced guidance for manufacturers of Class I medical devices
(118Kb) (Guidance Note No 7).
