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CE Markings

CE Markings

TSQ offers consultancy for compliance with European Directives and related harmonized standards. Machines, Medical Devices, In Vitro Diagnostic Medical Devices, Construction Products, PED, ATEX, Toys, PPE

In the context of European legislation, our advice focuses on the procedures that manufacturers, representatives, importers and distributors must follow to place products subject to CE Marking on the market.

We operate on all directives and regulations, mainly the following:
  • Machinery Directive 2006/42/EC and subsequent amendments
  • Medical Devices MDR 2017/745 and subsequent amendments
  • In Vitro Diagnostic Medical Devices IVDR 2017/746 and subsequent amendments
  • Construction products CPR 305/2011
  • PED 2014/68/EU
  • ATEX 2014/34/EU
  • Toys 2009/48/EC PPE 89/686/EEC
  • LVD (Low Voltage) 2014/35/EC
  • EMC (Electromagnetic Compatibility) 2014/30/CE
  • RED (Radio and Telecommunications Terminal Equipment) 2014/53/EC

Security
(ISO 45001)

Depending on the level of criticality of the product, each directive provides for different procedures for the presumption of conformity and therefore the possibility of affixing the CE mark on the product.

These procedures normally focus on two aspects:

1. Technical file or technical documentation on the typical product / product families
2. Manufacturing process control

Despite the many differences between one directive and another,
the typical certification process can be summarized as follows:

1. Preparation of the product technical file, technical documentation and/or results of the initial type tests
2. Design and implementation of a manufacturing control system
3. Audit of the Notified Body where foreseen

The levels of detail of the documentation and the methods of intervention of the Notified Body are differentiated according to the product.
TSQ technicians intervene in all phases up to complete CE marking and possible registrations (for example, for Medical Devices, Registration with the Ministry of Health). Together with the company, the applicable harmonized standards are evaluated, compliance with which guarantees the presumption of conformity and the possibility of placing the product on the market.

We collaborate with laboratories that are able to carry out tests for the main product standards. The service also includes the drafting of CE manuals, their regulatory review and verification, as well as the possibility of supplying systems for the coordinated management of an archive of manuals (for example for companies that have many products).

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