The manufacturer shall prepare technical documentation for the medical device to demonstrate due fulfilment of the general safety and performance requirements applicable to the device and take any other measures necessary to enable conformity assessment of the product. These documents shall be maintained and retained. The documents shall be made available to the authority upon request.
The intended purpose of the product assigned by the manufacturer determines whether the product has a medical intended purpose. The manufacturer shall classify its product according to the classification rules. The conformity assessment procedures that can be followed depend on the risk class of the device.
With regard to products of the lowest risk class, the devices may be placed on the market on the basis of the manufacturer’s own conformity assessment. For devices of other risk classes, the conformity assessment requires the participation of a notified body.
A notified body must be used for the assessment of medical devices in product classes IIa, IIb and III. A notified body must also be used for the assessment of a sterile device of risk class I, a device with a measuring function or reusable surgical instruments, limiting to aspects related to sterility, the measuring function or re-use.
The conformity assessment of class III implantable devices and class IIb active devices intended to administer and/or remove a medicinal product involves, in certain cases, the consultation of a scientific expert panel in relation to the clinical evaluation.
With regard to IVD devices, the use of a notified body is required for the devices listed in Annex II of the IVD Directive, as well as for all devices intended for self-testing. Following the application of the IVD Regulation (as of 26 May 2022), the assessment of a notified body is required for IVD devices of product classes B, C and D. The conformity assessment of sterile IVD devices of class A of the Regulation requires a notified body with regard to sterility-related aspects. In addition, the conformity assessment of class D IVD devices requires performance verification by a European reference laboratory and/or consultation of a scientific expert panel. A European reference laboratory is also involved in the batch verification of class D devices.
Additionally, for IVD devices that are companion diagnostics products, the conformity assessment will, following the application of the IVD Regulation, involve consultation with a medicinal products competent authority under Directive 2001/83/EC or the European Medicines Agency.
Notified bodies are independent inspection bodies designated by the EU Member States. A notified body is under the supervision of the authority of the Member State that designated it. The manufacturer is free to use any European notified body with a suitable area of competence. A list of notified bodies and their areas of competence can be found in the NANDO database maintained by the EU Commission. So far there are two notified bodies established in Finland, Eurofins Expert Services Oy and SGS Fimko Oy.
The manufacturer shall issue a written declaration that the medical device the device is in conformity with the regulatory requirements. The medical devices regulations define the content of the declaration for devices in conformity with the regulations. The declaration of conformity of devices placed on the market under the directives shall comply with section 6 of Administrative Regulation 1/2011.
Article 52 of the Medical Devices Regulation and Article 48 of the IVD Regulation set out the procedures for devices of different risk classes that are to be followed by the manufacturer to demonstrate conformity.
The procedures for demonstrating conformity set out in Administrative Regulation 1/2011 (National Supervisory Authority for Welfare and Health Regulation of 18 March 2011) are only valid for IVD devices up until the date of application of the IVD Regulation (2017/746) (26 May 2022). After the date of application of the IVD regulation, new devices can no longer be placed on the market according to the procedures set out in said regulation 1/2011, but certain MD and IVD devices can continue to be manufactured under the transitional provisions set out in the regulations (EU/2017/745, Article 120, and EU/2017/746, Article 110) for a certain period after that (up until 26 May 2024). See also commission Regulation (EU) 2017/746 (EU) 2022/112 for amendments to the transitional provisions of the IVD regulation.
CE-marking of Medical Devices (MD and IVD directive) - Fimea 5/2022 (Not available in English)