The European Commission of the European Union (EU) answers questions on certain issues regarding the security of products (connected devices) as well as software.
Below is a summary of the questions and answers from the European Commission:
Q: Does the Union harmonisation legislation, including the radio equipment directive (RED) apply to newly manufactured products/second-hand products? What if software is updated while the equipment is in use?
A: The Union harmonisation legislation applies to newly manufactured products, but also to used and second-hand products if they are imported from a third country when they enter the Union market for the first time. Depending on the effect of the software change, the RED may re-apply.
Q: What are the applicable conformity assessment procedures? Can different conformity assessment procedures be followed for each applicable point in the RED? Is it required to involve a Notified Body and when?
A: Article 17 of the RED describes the applicability of each conformity assessment procedure (Annex II, III or IV) with a view to meet the essential requirements set out in Article 3. A Notified Body shall be involved if harmonised standards are partially applied, not applied, or do not exist.
Q: What does 'classes and categories' of radio equipment mean? Can a delegated act define them by using terms such as 'equipment whose conformity can be impacted because of the uploaded of software?
A: Classes and categories specify the products by referring to their name-type and define products using generic terms. The delegated act cannot define a class or category of radio equipment by using such terms because such definition might lead to legal uncertainty.
Q: Can delegated acts under Article 3 (3) of the RED set out any detailed technical specifications?
A: Detailed technical specifications may be set out in harmonised standards, but should not be addressed in those delegated acts.
Q: Is it possible on the basis of delegated acts under Articles 3 (3) and/or 4 of the RED to extend the obligations of the manufacturers of radio equipment so that they are obliged to ensure that the radio equipment continues to be compliant when in operation (i.e. after it has been placed on the market)?
A: No, the delegated act cannot go beyond the scope of the RED which applies when the radio equipment is first placed on the market. The equipment shall comply with the requirements applicable at the time the product was placed on the market and then the relevant economic operators, when they make the product available, shall ensure that the equipment is compliant with those requirements.
Q: Can a delegated act under Articles 3 (3)/4 of the RED cover (include in its scope) radio amateur equipment?
A: According to Annex I to the RED, radio amateur equipment is excluded from the RED unless the equipment is made available on the market.
Q: Should any solutions, including those followed for the purposes of compliance with Article 3 (3) (d), (e), (f) and (i) as well as 4 of the RED, cover the entire life cycle i.e. the normal operation of the equipment?
A: The manufacturer should insert features that can be functional for the reasonable life cycle of the radio equipment concerned but adapted to the technical solutions available (reasonably known) at the time the product was placed on the market.
Q: If the manufacturer does not provide updates, would that be a reason to prohibit the putting into service and use of the device if it is established that it will not be compliant without the updates which are needed to keep the device in compliance during its lifetime?
A: The manufacturer should choose such a type of software which would ensure a compliance during the reasonable lifetime of the product.
Q: When shall the technical features, referred to in Article 3 (3) of the RED, be incorporated/installed? What technical solutions shall be taken into account? If new requirements become applicable or new solutions are available, while the equipment is in use, has the manufacturer any obligation to take those into account?
A: The features that the manufacturers need to incorporate/install under Article 3 (3) shall be incorporated/installed at the time of the placing on the market. The RED is applicable at the time of placing on the market.