Certification Services
EU-Cert

Certification of personal protective equipment according to Regulation (EU) 2016/425 (PPER)

Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment. This Regulation lays down requirements for the design and manufacture of personal protective equipment (PPE) to be made available on the market, with a view to ensuring the protection of the health and safety of users, and to laying down rules on the free movement of PPE within the Union.

Products covered by the scope of accreditation and notification:

• Buoyancy aids,
• Chest and groin protection equipment,
• Eye protection equipment,
• Face protection equipment,
• Foot and leg protection equipment and slip protection equipment,
• General body protection equipment (clothing),
• Equipment providing hand and arm protection,
• Equipment providing hand and arm protection against chemical agents,
• Head protection equipment,
• Cold protection equipment [> -50 °C],
• Cold protection equipment [cold > -50 °C], [extreme cold <-50 °C],
• Equipment providing protection against extreme cold [<-50 °C],
• Equipment providing protection against heat [<100 °C], <
• Equipment providing protection against heat [> 100 °C, and fire and flames]
• Equipment providing protection against heat [heat <100 °C], [heat > 100° C and fire],
• Respiratory protective equipment,
• Drowning protection equipment,
• Electrical shock protection equipment,
• Equipment protecting against falls from a height,
• Equipment protecting against biological agents,
• Equipment to protect against mechanical hazards,
• Anti-slip equipment,
• Equipment to protect against substances and mixtures that are hazardous to health,
• Equipment that protects against chemical agents,
• Equipment that protects against injuries resulting from sports activities,
• Specialized areas of expertise: protective clothing for use in welding and related processes,
• Specialized areas of expertise: firefighter clothing,
• Specialized areas of expertise: diving protective equipment.

Within the framework of Regulation (EU) 2016/425, we can carry out conformity assessment processes in the following areas:

• EU-Module B Type Testing,
• Supervised product inspections at random intervals – C2 module,
• Conformity to type based on quality assurance of the production process – Module D.

Certification of marine equipment according to Directive 2014/90/EU, also known as the Marine Equipment Directive (MED)

Directive 2014/90/EU of the European Parliament and of the Council on July 23, 2014 on marine equipment. This Directive is intended to enhance maritime safety and prevent marine pollution through the uniform application of relevant international instruments on marine equipment to bé placed on EU vessels, and to ensure the free movement of such equipment within the Union.

Products within the scope of accreditation and notification

EU-Cert Sp. z o.o. is competent to carry out conformity assessment processes with the requirements of the MED Directive for the following groups of products specified in the Commission (EU) Implementing Regulation*:

• rescue equipment, e.g.: vests, life rafts, lifeboats,
• fire protection measures, e.g.: non-combustible materials, fire detection systems, extinguishing systems, fire extinguishers, personal protective equipment,
• equipment required under COLREG’72: navigation lights,
• other safety equipment: independent compressed air breathing apparatuses.

* The full list of product groups covered by the MED Directive is contained in the Executive Order (EU). There, the applicable requirements of international regulations and conformity assessment procedures applicable to individual items of marine equipment are specified.

Within the framework of Directive 2014/90/EU, we can carry out conformity assessment processes in the following areas:

• Module B* – EC type testing,
• Module D – production quality assurance,
• Module E – product quality assurance,
• Module F – product verification,
• Module G – unit verification.

* Module B is the part of the conformity assessment procedure that requires a further assessment for one of the quality assurance modules – D or E or the product verification module – F. This does not apply to certification for module G (unit verification).

Certification of pressure equipment according to Directive 2014/68/EU, also known as the Pressure Equipment Directive (PED)

EU-Cert Sp. z o. o. has accreditation No. AC 230 issued by PCA in the field of Directive 2014/68/EU of May 15, 2014 on the harmonization of the laws of the Member States relating to the making available on the market of pressure equipment (PED). This Directive establishes requirements for the design and manufacture of pressure equipment for which the maximum allowable pressure PS is greater than 0.5 bar, as well as pressure equipment assemblies, consisting of several pieces of pressure equipment, assembled so as to form together an integrated and functional whole, if placed on the market by the manufacturer and put into service as an assembly. Pressure equipment includes vessels, piping, safety fittings and pressure accessories.

EU-Cert Sp. z o.o. has the competence to carry out conformity assessment processes with the requirements of the PED Directive for pressure equipment.

In the area of the PED Directive, it conducts conformity assessment processes according to the following modules:

Without a quality system

• Module A2 – Internal control of production + supervision of final evaluation,
• Module B – EC design type testing,
• Module C2 – conformity to type based on internal production control and supervised inspection of pressure equipment at random intervals,
• Module F – conformity to type based on verification of pressure equipment,
• Module G – compliance based on unit verification.

With a quality system

• Module D – conformity to type based on quality assurance of the production process,
• Module D1 – conformity to type based on quality assurance of the production process,
• Module E – conformity to type based on quality assurance of pressure equipment,
• Module E1 – quality assurance of inspection and testing of finished pressure equipment,
• H1 module – compliance based on full quality assurance and project investigation.

Certification of Factory Production Control (FPC) according to PN-EN 1090-2 (ZKP)

EU-Cert Sp. z o. o. is accredited by PCA with accreditation No. AC 231 for the conformity assessment of factory production control (FPC) in the 2+ system. Regulation 305/2011 EU stipulates that CE marking is mandatory. The CE marking of a manufacturer’s own product requires the manufacturer to carry out an assessment of the product’s conformity with the harmonised technical specification. A prerequisite for the manufacturer to carry out the conformity assessment is to have a described, implemented and certified factory production control (FPC) system. The certificate of conformity of the factory production control is issued for an unlimited period of time and remains valid as long as the requirements of the harmonised technical specification, the production conditions or the system itself are not substantially modified. Supervision of the issued certificate takes place once a year.

The conformity assessment and monitoring of CE marking by EU-Cert Ltd. has the following objectives:

• confirmation of compliance with legal requirements,
• proving that the products are suitable for the purposes for which they are intended,
• ensure the removal of barriers to trade and the free movement of products in the EU,
• increasing consumer and customer confidence.

Responsibilities of the manufacturer:

• preliminary product type testing,
• maintaining a documented production control system,
• testing samples taken at the factory, according to the established test plan,
• issuance of a declaration of performance.

Responsibilities NB2984:

• Initial inspection of factory production control,
• continuous supervision, evaluation and approval of factory production control,
• issuance of a certificate of factory production control.

Certification of drones according to Regulation (EU) 2019/945 (BSP) involves ensuring the compliance of unmanned aircraft systems (UAS)

EU-Cert Sp. z o. o. is accredited by PCA No. AC 231 for Regulation (EU) 2019/945 for drones intended for operation in the open category and additives for unambiguous remote identification.

By obtaining this accreditation, EU-Cert Sp. z o. o. has become one of the first bodies in Europe to test and assess conformity according to Regulation (EU) 2019/945. This achievement is the result of work that required the development of advanced flight test methods. The requirements are aimed at ensuring the safety of drones entering the European market. According to Regulation (EU) 2019/945, unmanned flying systems must meet the requirements before they can be placed on the EU market. Manufacturers ensure that their products meet the essential safety requirements. A notified body must be involved in conformity assessment procedures for Class 1, Class 2 and Class 3 UAVs, and may be involved for Class 0, Class 4 and additive UAVs. Our conformity assessment process is based on European Union requirements. Our testing and certification activities cover open category unmanned aircraft systems and add-ons. EU-Cert Ltd. as an independent third party is competent to assess conformity for unmanned aircraft in the open category of Class C0, C1, C2, C3, C4 and elements for unambiguous remote identification.

Conformity assessment modules for the CE mark:

Conformity assessment modules in accordance with Regulation (EU) 2019/945 can be selected by manufacturers:

• Conformity assessment Module A – Internal production control: Only for Class C0, Class C4 unmanned aerial vehicles and add-ons.
• Conformity assessment Modules B and C- EU type testing and conformity to type based on internal production control.

Since the regulation in the EU is in transition, the notifications of the bodies conducting the above-mentioned assessments are pending. At EU-Cert Ltd. we are proud to have drone experts who have developed the necessary procedures to demonstrate compliance in the field of BSP testing and certification. We are happy to guide manufacturers or importers in the process of assessing the conformity of their systems so they can bring their product to the European market.