Hotspot: Notified Body Focus on PED Technical File Requirements

What is it? 

The purpose of this Hot Spot is to alert members to the importance of ensuring that the technical documentation that they rely upon for PED approval is up to date and sufficient to meet the requirements of the current Directive 2014/68/EU.

It is important to recognise that the technical documentation requirements for the PED changed from 2014 with the issue of the current directive. More specific documentation requirements were included in Annex III meaning changes to the existing technical documentation were likely to be necessary. Members who gained PED certification before 2014 and have not recently reviewed their files against current directive requirements may find that they need to make significant revisions to their documentation.

Technical documentation most likely to need reviewing against current PED requirements is as follows:

• Product design files- a minimum of one file for each model of each product type should be compiled and up to date with any design changes.
• Particular material appraisals for the use of all none harmonized materials.
• Hazard and risk assessments documenting how each product type satisfies the essential safety requirements of the PED should be up to date and referencing the necessary standards.

Why is it Important? 

The Brexit deadline of 31-12-20 is fast approaching and members must have their PED certification issued by an EU based Notified Body by this date. The resources of many Notified Bodies are likely to be challenged by the numbers of PED approval applications that need to be completed to allow transfer from UK based Notified Bodies to EU ones as we approach the end of the year.

Several members have reported that Notified Bodies are requesting them to make extensive updates to technical documentation before they can be approved by a new EU based Notified Body. This is the case even when the new Notified Body is part of the same overall organisation as their previous one. It is strongly recommended that members review and where necessary update their technical documentation prior to submitting it to their new Notified Body in order to avoid potentially lengthy delays putting at risk the transfer of their PED certification prior to the 31-12-20 deadline.

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