Implementation dates (Article § 120)
- Published on 5 May 2017
- Entry into force on 26 May 2017
- Application compulsory from 26 May 2020 (4 extra years possible for medical devices that already have CE marking as of 26 May 2020 and according to their certificate’s expiry date).
- Certificates issued by notified bodies in accordance with directives 90/385 and 93/42 from 25 May 2017 remain valid until the end of the period indicated on these certificates and cannot exceed five years. They are, nevertheless invalidated at the latest by 27 May 2024.
- Certificates issued in accordance with annex IV of the directives 90/385 and 93/42 are invalidated by 27 May 2022 at the latest
Note that the deadlines are very short for new devices and/or new manufacturers.
Note also for devices that are going to change class with certificates and-or self-evaluations that will be invalidated on 26 May 2020.
Schedule for the implementation of regulation 2017/745
- In this schedule, see also the implementation of the UDI (Unique Device Identification)
- Registration in the EUDAMED database
- Setting of UDI on packaging
- Setting of UDI on devices
CLASSIFICATION OF MEDICAL DEVICES ACCORDING TO REGULATION 2017/745 ANNEX VIII
New indications:
In calculating the duration , continuous use shall mean:
- the entire duration of use of the same device without regard to temporary interruption of use during a procedure or temporary removal for purposes such as cleaning or disinfection of the device. Whether the interruption of use or the removal is temporary shall be established in relation to the duration of the use prior to and after the period when the use is interrupted or the device removed; and
2. the accumulated use of a device that is intended by the manufacturer to be replaced immediately with another of the same type
A device is considered to allow direct diagnosis when it provides the diagnosis of the disease or condition in question by itself or when it provides decisive information for the diagnosis.
NEW RULEs
Rule 11: Software designed to provide data used to make therapeutic or diagnostic decisions belong to class IIa, unless these decisions have an effect which may cause:
- Death or an irreversible deterioration in the person’s state of health, in which case it belongs to class III, or
- A serious deterioration in the person’s state of health or a surgical procedure, in which case it belongs to class IIb.
Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.
All other software is classified as class I.
Rule 19: All devices incorporating or consisting of nanomaterial are classified as:
- Class III if they present a high or medium potential for internal exposure,
- Class III if they present a low potential for internal exposure,
- Class IIa if they present a negligible potential for internal exposure.
Rule 20: All invasive devices with respect to body orifices, other than surgically invasive devices, which are intended to administer medicinal products by inhalation are classified as class IIa, unless their mode of action has an essential impact on the efficacy and safety of the administered medicinal product or they are intended to treat life-threatening conditions, in which case they are classified as class IIb.
Rule 21: Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body are classified as:
- Class III if they, or their products of metabolism, are systemically absorbed by the human body in order to achieve the intended purpose
- Class III if they achieve their intended purpose in the stomach or lower gastrointestinal tract and they, or their products of metabolism, are systemically absorbed by the human body
- Class IIa if they are applied to the skin or if they are applied in the nasal or oral cavity as far as the pharynx, and achieve their intended purpose on those cavities, and
- Class IIb in all other cases.
Rule 22: Active therapeutic devices with an integrated or incorporated diagnostic function which significantly determines the patient management by the device, such as closed loop systems or automated external defibrillators, are classified as class III.