At this point, the manufacturer has chosen a certification path and then needs to write down the documentation according to the conformity assessment. To do so, the manufacturer needs to understand which are the requirements that the product or production must meet in order to be complaint.
Essential Requirements
Essential requirements define the results to be attained or the hazards to be dealt with, but do not specify the technical solutions for doing so. Those requirements are designed to ensure a high level of protection and arise from certain hazards associated with the product, its performance, a protection objective or a combination of these.
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Apart from general requirements, MDD states requirements regarding design and construction which include: physical and chemical properties, microbial contamination, environmental properties, measuring function, protection against radiation, energy sources and information that the manufacturer has to supply (commonly known as instructions for use and labels).
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IDENTIFY ESSENTIAL REQUIREMENTS
The description of the essential requirements for medical devices is set out in
Annex I to Directive 93/42/EEC.
Read that annex carefully to see if there is some special case disposition the device should fulfil.
RISK ANALYSIS
Use the GUIDE to learn how to perform a Risk Analysis.
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Use CEEASY's template. You will save a lot of time!
Once all the essential requirements are identified. It is time to perform a risk analysis. In this way, the manufacturer is able to identify all possible risks, determine the applicable essential requirement and apply it, which must result in: eliminating or reducing the risk (safe design and construction), take adequate protection measures (for risks than cannot be eliminated) and inform users of the residual risks.
Harmonized Standards
While essential requirements just state the results that have to be achieved, not how; harmonized standards give detailed manufacturing specifications. The degree of detailed wording in standards is intended to create legally binding obligations, but they do leave room to technical interpretation. In order to facilitate the standardisation of the requests, the European Commission assigned different European organizations (CEN, CENELEC, ETSI ) to develop standards in accordance with the essential requirements of the directives.
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Standards in Europe
New Approach Standardisation