Facial mask and PPE EU Certification during COVID-19 emergency

di ing. Manuel de Crescenzo

Face masks

Current standards

Because of COVID-19 emergency, the Italian Ministry of Health allows companies to design and manufacture medical devices like facial masks and personal protective equipment (PPE) by derogation, and not according to Directive 93/42/EEC or EU Regulation 2016/425.

In particular, it is possible to produce facial masks by way of derogation from Art. 34, paragraph 3 of the decree issued by the Italian Government on March 2nd 2020 and Art. 15 of the decree issued on March 17th 2020, n. 18.

In this respect, companies can put medical devices on the Market by implementing a Quality Management System (QMS) for Production and complying with the following requirements:

Facial masks

  • product conformity to the UNI EN 14683 current revision standard;
  • product conformity to the UNI EN 10993-1 current revision standard;

PPE

  • product conformity to the UNI EN 149 current revision standard.

The achievement of the above-mentioned targets has led Studio Europa to increase its knowledge of the production of these devices and it has become one of the most expert consultancy firms in the field.

STUDIO EUROPA’s methodology

Studio Europa follows a number of different operational and essential steps:

  • National Institute of Health

In order to get the authorisation procedure started and implement the QMS, Studio Europa drafts the technical documentation to be sent to the Italian National Institute of Health.

  • Company’s structure diagnostics

Subsequently, Studio Europa studies the structure of the company, in particular the overall context, its production methods and the activities of each business function. The company operational processes will be set out and summarized in specific documents that are necessary to re-plan and adapt the Quality System Management to current standards.

  • Quality Manual and required business procedures

A Quality Manual (QM) provides the formalization of Quality Management System and the allocation of responsibilities of each business function. In this regard, Studio Europa draws up different documents concerning business procedures and working instructions to be followed to get and maintain the Quality standards that have been proved in phase of evaluation. In short, Studio Europa will make company conform to Quality Management System requirements, by providing the elements to include in its operating structure.

  • Training on the job

Studio Europa is a strong supporter of vocational training.

In fact, when setting a common goal, it is necessary to organize regular meetings with leaders and employees of a company to make the various roles clear and formalise tasks and responsibilities of each business function.

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