12
JUN
2019

The new EASA approach for the definition of Level of Involvement (LOI)

On 3 June 2019, the European Commission has published Commission Regulation (EU) 2019/897 amending Regulation (EU) No 748/2012 as regards of the inclusion of risk-based compliance verification and the implementation of requirements for environmental protection.

The main element of this Regulation is an amendment of the certification process in respect of what is commonly referred to as “Level of Involvement (LOI)”.

The new LOI concept
Affected applicants will have to propose a break-down of the certification programme into meaningful groups of compliance demonstration activities and data (ref to point 21.A.15(b)(5)and similar provisions).
Then, for each identified group of compliance demonstration activities and data, the affected applicants will have to perform a risk assessment considering the likelihood of an unidentified non-compliance with the type-certification basis, operational suitability data certification basis or environmental protection requirements and the potential impact of that non-compliance on product safety or environmental protection. 
Based on this assessment, the applicant shall make a proposal for the Agency's involvement in the verification of the compliance demonstration activities and data.

EASA will determine its LOI considering the proposals submitted by the affected applicants.

Details about this new LOI concept, as well as possible means of compliance with these new points in Part 21,  have been presented by EASA e.g. at:

Event Date Link to the video Remarks
Product Certification and DOA workshop 22/11/2017    https://www.youtube.com/watch?v=K0D9aBJDEcI&index=3&list=PLTfS24aKkJn5BPBzeSpgI_
R0kGED_2n4-&t=0s
Contains also some practical examples  
STC workshop 04/05/2018 https://www.youtube.com/watch?v=gQ6mGeJMITQ&list=PLTfS24aKkJn4ZcYVNkREdl_niZme4vu
YZ&index=8&t=0s

The following material is currently available

Document Publication date  Status Link  Comment
Regulation
Regulation (EU) 2019/897 (Amendment to Part 21) 03/06/2019   adopted   https://www.easa.europa.eu/document-library/regulations/commission-delegated-regulation-eu-2019897 Entry into force: 23/06/2019
Applicability for LOI, refer to below picture    
Guidance Material
NPA 2017-20    15/12/2017  Published for consultation  https://www.easa.europa.eu/document-library/notices-of-proposed-amendment/npa-2017-20 The Decision adopting (based on the proposals in the NPA and the comments received during its consultation) the AMC/GM affected by this amendment to Part 21 will be published by mid of August 2019.
NPA 2019-03 03/04/2019 Published for consultation  https://www.easa.europa.eu/document-library/notices-of-proposed-amendment/npa-2019-03
CM-21.A/21.B-001 issue 1 02/07/2019 First issue https://www.easa.europa.eu/document-library/product-certification-consultations/cm-21a21b-001  

Applicability - when does the new LOI become mandatory?

More information and training
As the new amendment of Part 21 incorporates a significant number of changes, EASA will organise 5 events to explain to interested stakeholders the amendments to Part 21 in order to ensure a smooth implementation. 

During these events, EASA will explain the amended rules and the expected impacts to design organisations, including the new LOI concept. EASA will also describe acceptable means to comply with the new requirements. 

List of scheduled events:

Location Date Link for enrolment
Rome - Italy 25 - 26/06/2019 https://www.easa.europa.eu/newsroom-and-events/events/new-part-21-amendment-what-changing-me-rome
Prague - Czech Republic 03 - 04/09/2019 https://www.easa.europa.eu/newsroom-and-events/events/new-part-21-amendment-what-changing-me-prague
Cologne - Germany 18 - 19/09/2019 https://www.easa.europa.eu/newsroom-and-events/events/new-part-21-amendment-what-changing-me-cologne
Toulouse - France 30 - 31/10/2019 https://www.easa.europa.eu/newsroom-and-events/events/new-part-21-amendment-what-changing-me-toulouse 
Derby - United Kingdom 2020 (exact date to be confirmed) to be confirmed

 

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