Inspection process for Category III Personal Protective Equipment
A manufacturer cannot place on the market or bring into service any Category III PPE without having established a formal agreement with a Notified Inspection Body about Regulation (EU) 425/2016* Annex VII (Module C2) assessment.
The Inspection process for Category III PPE can be initiated by filling out and submitting an application form.
The Inspection process can be initiated after the applicant submitted an application for EU type-examination to a Notified Certification Body.
Applicant makes statements by filling out and submitting the application form:
- The applicant submitted an application for EU type-examination certificate to a Notified Body or the EU type-examination certificate had been issued by a Notified Body.
- The applicant submitted an application for Inspection to any other organization.
The following should be attached to the application form, as a minimum requirement:
- EU type-examination certificate with annexes and EU type-examination test reports (if these documents had been issued by a Notified Body);
- One copy of Application Form for EU type-examination certificate (if the EU type-examination certificate had not been issued);
- Technical documentation of PPE and information supplied by the manufacturer;
- Technical specifications for manufacturing process;
- EU declaration of conformity (if it had been issued by the manufacturer);
- One copy of Expert Report about the latest Inspection assessment (if it had been performed by any other Notified Body).
If the documents (above) are not available in Hungarian or English version, please attach a certified Hungarian translation.
The Inspection Body performs the documentation review.
If the Category III PPE does not fall under the scope of the Inspection Body’s activities, then the Head of Inspection Body refuses the application.
If any data or document is missing or incomplete, the applicant will be informed.
After the applicant performed the supplementation of documents, we make an offer and provide information about the required tasks that must be carried out by the applicant during the inspection process.
After the confirmation of the contract, the Category III PPE receives an identification number in the system of the Inspection Body.
The first Inspection assessment will be performed after the issue of EU type-examination certificate and the start of production BUT before the manufacturer places on the market or brings into service the Category III PPE.
Inspection assessment will be performed at the place of production.
The Inspection Body checks the homogeneity of the production, the documentation of manufacturing process, the product conformity with the certified type – which is described in the EU type-examination certificate – and with the Basic Health and Safety Requirements.
An adequate sample of PPE shall be taken and examined by the Body – the appropriate tests defined in the harmonized standards – to check the conformity of PPE.
The checks must be carried out at a minimum of one per year, starting from the date of the EU-type examination certificate issue until the end of validity.
Following the inspection the Notified Body gives the manufacturer an expert report that concludes, in view of the test results, whether or not there is any sign of non-homogeneity in the manufacturing process and whether or not the PPE examined conforms to the type described in the EU-type examination certificate and the relevant Basic Health and Safety Requirements.
If the results of the checks are satisfactory, the Notified Body concludes that the manufactured PPE is in conformity.
Inspection process in cases of non-homogeneity or non-conformity of PPE:
In cases of non-homogeneity or non-conformity of PPE the Inspection Body is required to inform the:
- manufacturer of the implementation of corrective actions are requested which may include halting production and set a time limit;
- Certification Body that has issued the EU-type examination certificate of the defects found on the basis of which that Notified Body might consider to suspend or withdraw the relevant certificate;
- Notifying Authority - Ministry for National Economy.
At the end of the time limit the Inspection Body repeats the appropriate checks. An adequate sample of PPE shall be taken and examined by the Body to check the conformity of PPE.
Inspection Body is required to inform the Certification Body and the Notifying Authority of the results of Inspection.
* The European Direktive 89/686/EEC of 21 April 2018, was replaced by Regulation (EU) 2016/425 of the European Parliament and of the Council.