The device shall be designed, manufactured, packaged and labelled in such a way as to be suitable for the purpose intended by the manufacturer. In order to place a device on the market, the manufacturer shall ensure that the device meets the applicable general safety and performance requirements set out in Annex I to the Regulation(s). For the time being, it is also possible to apply the corresponding Annex I to the IVD Directive 98/79/EC (the so-called ‘essential requirements’) to IVD devices.
The technical documentation shall contain information for the demonstration of conformity with the general safety and performance requirements taking into account the intended purpose of the device, and shall include a justification, validation and verification of the solutions adopted to meet those requirements. The demonstration of conformity shall include:
- a list of the general safety and performance requirements that apply to the device and an explanation as to why others do not apply;
- details of the harmonised standards*, common specifications or other solutions applied;
*An up-to-date list of harmonised standards is maintained on the Commission website. Harmonised standards mean European standards (EN) the references of which are published in the Official Journal of the European Union. In Finland, an EN standard is adopted as a national SFS-EN standard.
- details of documents offering evidence of the application of harmonised standards, common specifications or other methods to demonstrate conformity with the general safety and performance requirements. The information shall incorporate a cross-reference to the location of such evidence within the full technical documentation and, if applicable, the summary technical documentation,
The manufacturer is required to carry out a risk analysis to identify any hazards associated with the product and to eliminate or minimise the risks resulting from them. More detailed description of risk analysis is given in SFS-EN ISO 14871. Documentation of the design and manufacture of the device must be retained for supervision purposes. Annexes II and II of the Regulations (2017/745 and 2017/746) describe the technical documentation required. Respectively, Annex III of the IVD directive describes the technical documentation requirements for devices placed on the market according to the directive.
The authority shall consider the device to be in conformity with the general safety and performance requirements insofar as it meets the applicable requirements of the harmonised standards and/or common specifications. The use of standards is voluntary for the device manufacturer. If the manufacturer does not rely on harmonised standards, it must demonstrate by other means that the device meets the applicable general safety and performance requirements.
Read more about standardization
Standards in Europe (EU)
Finnish standards association, SFS
Harmonised Standards (European commission)
Official Journal of the European Union, L 090I
COMMISSION IMPLEMENTING DECISION (EU) 2021/610
COMMISSION IMPLEMENTING DECISION (EU) 2020/437