Documentation Support

When looking to place products on the market, most national and international regulatory systems require the compilation of technical documentation to prove safety compliance.

Required technical documentation can range from test reports to compilations of detailed and structured design, quality management, test results and evaluation data.

When it comes to UK and European markets, precise content and format of these important documents depends on the relevant regulations or directives.  The necessary support documentation, commonly referred to as a ‘Technical File’ (TF) should include documentation that supports your compliance strategy.

In many cases they can be complex and time consuming to compile. Their preparation will often require specialist technical knowledge and a detailed understanding of specific regulations or directives. Aspects such as Risk Assessments, Essential Health and Safety Requirements (EHSRs), Declaration of Conformity (DOC), Declaration of Incorporation (DOI), all have their place in support of your legal obligation.

It should be remembered that the market surveillance authorities in Europe and the UK have the power to request a copy of your Technical File. If they have reason to believe your product is unsafe, they have the authority to stop shipment of products, impound products and even seek prosecution.

At Technology International we support our clients to ensure that compliance documentation is prepared accurately, efficiently and meets the requirements of the applicable Regulations.

How Can We Help You? 

This support can be offered in a variety of packages:

• Initial documentation review & GAP analysis – Review existing Technical File, including all support documentation such as manuals, certificates, drawings, and referenced standards. We check to ensure that the documents are both present and up to date.
• CE to UKCA transition – If all your existing support documentation for CE marking is correct and up to date then the transition across to UKCA can be a relatively straight forward task. We can give you guidance on the best practice and most efficient ways to show UKCA conformity.
• Technical File compilation – We can offer help with individual sections or the whole compilation of a TF. It should be remembered that a TF is a ‘live’ document and should accurately reflect the product(s) they cover. With the right structure, the ongoing ‘maintenance’ of the TF is kept to a minimum.
• EHSRs (Essential Health and Safety Requirements) review/compilation – The ESHRs in the UK Regulation and the European Directive for machinery, can be consider a list of required principles that the designer should follow. We help guide you on the correct use of any relevant support standards which best demonstrate compliance with your legal obligations.
• Risk Assessments – Either on-site or remote. This activity forms an integral part of the TF to help link the choice of standards followed, against the EHSRs, under both UK and European Machinery legislation.
• Declaration of Conformity (DOC) / Declaration of Incorporation (DOI) compilation – These documents can be considered a ‘window’ into how comprehensive and up to date a manufacturer is, with their support documentation. We can give guidance on what should be included in your product’s DOC / DOI to demonstrate compliance.

We work with Manufacturers, Importers and End-Users to ensure that the correct documentation is available and can, if necessary, be delivered to the regulatory authorities.

We have long-standing expertise in compiling Technical Files to demonstrate compliance with European (CE) Directives as well as UK (UKCA) Regulations.

For infrastructure projects, Technology International has a wealth of experience in the preparation of Compliance Management Plans and delivering full Safety Case or Assurance Submissions prior to final commissioning.