COMMISSION DELEGATED REGULATION (EU) 2024/3173
of 27 August 2024
supplementing Regulation (EU) 2023/988 supplementing Regulation (EU) 2023/988 of the European Parliament and of the Council with regard to rules on access to and operation of the Safety Gate Rapid Alert System, information to be entered in that System, notification requirements and the criteria for assessment of the level of risk
(Text with EEA relevance)
Article 1
Article 2
Article 3
ANNEX I
RULES ON ACCESS TO AND OPERATION OF THE SAFETY GATE RAPID ALERT SYSTEM, INFORMATION TO BE ENTERED IN THAT SYSTEM AND NOTIFICATION REQUIREMENTS
1. TYPES OF NOTIFICATIONS THROUGH THE SAFETY GATE RAPID ALERT SYSTEM
1.1.
Serious risk notification
1.2.
Other risk notification
1.3.
Notification for information
1.4.
Follow-up notifications
1.5.
Alerts sent by the Commission
2. INFORMATION TO BE INCLUDED IN NOTIFICATIONS SUBMITTED BY NATIONAL AUTHORITIES THROUGH THE SAFETY GATE RAPID ALERT SYSTEM
3. CHECK OF NOTIFICATIONS BY THE COMMISSION AND PUBLICATION
4. UPDATE OF NOTIFICATIONS
5. SPECIFIC RULES CONCERNING FOLLOW-UP NOTIFICATIONS
6. REMOVAL OF NOTIFICATIONS FROM THE SAFETY GATE RAPID ALERT SYSTEM AND THE SAFETY GATE PORTAL
ANNEX II
CRITERIA FOR ASSESSMENT OF THE LEVEL OF RISK
1. DEFINITIONS
2. RISKS
2.2.1.
Risks to health and safety
2.2.2.
Risks to public interests other than those referred to in point 2.2.1 as regards products covered by Regulation (EU) 2019/1020
3. SEQUENCE WHEN ASSESSING THE LEVEL OF THE RISK
3.1.
Assessment of the anticipated harm scenario
3.2.
Harm scenario: steps leading to harm(s)
3.3.
Severity of the injury or harm
|
Severity description |
|
Harm level |
Health/safety harm |
Other harm |
4 |
Life-threatening: harm or consequence that is or could be fatal, including brain death; consequences that affect reproduction or offspring; severe loss of limbs and/or function, leading to more than approximately 10 % of disability. |
Large negative effect, irreversible in several aspects, whether or not acute. |
3 |
Severe: harm or consequence that normally requires hospitalisation and will affect functioning for more than 6 months or lead to a permanent loss of function. |
Significant negative effect, significant effort to reverse by specialist intervention, irreversible without this intervention and effort. |
2 |
Moderate: harm or consequence for which a visit to the hospital may be necessary, but in general, hospitalisation is not required. Functioning may be affected for a limited period, not more than 6 months, and recovery is more or less complete. |
Negative effect, reversible within a certain period, specialist intervention is required. |
1 |
Minor: harm or consequence that after basic treatment (first aid, normally not by a doctor) does not substantially hamper functioning or cause excessive pain; usually the consequences are completely reversible. |
Negative effect, usually completely reversible within the short term without specialist intervention. |
3.4.
Probability of harm
Probability of occurrence of the harm scenario during the foreseeable lifetime of the product |
|
Higher or equal to 50 % |
Very frequent |
Between 5/10 and 1/10 |
Frequent |
Between 1/10 and 1/100 |
Common |
Between 1/100 and 1/1 000 |
Occasional |
Between 1/1 000 and 1/10 000 |
Unlikely |
Between 1/10 000 and 1/100 000 |
Unusual |
Between 1/100 000 and 1/1 000 000 |
Rare |
Lower or equal to 1/1 000 000 |
Extremely rare |
3.5.
Expressing the probability of the materialisation of the harm
3.6.
Determining the level of risk
Probability of occurrence of the harm during foreseeable lifetime of the product |
Severity of harm |
||||
1 |
2 |
3 |
4 |
||
High
Low |
> 50 % |
H |
S |
S |
S |
> 1/10 |
M |
S |
S |
S |
|
> 1/100 |
M |
S |
S |
S |
|
> 1/1 000 |
L |
H |
S |
S |
|
> 1/10 000 |
L |
M |
H |
S |
|
> 1/100 000 |
L |
L |
M |
H |
|
> 1/1 000 000 |
L |
L |
L |
M |
|
< 1/1 000 000 |
L |
L |
L |
L |
S – Serious Risk |
H – High risk |
M – Medium risk |
L – Low risk |