Our reference projects demonstrate success in a wide range of projects and industries

CE marking of conveyor machines for component separation of small parts and feeding to further processing steps

easyCE supports the entire conformity assessment procedure, including risk assessment, up to the declaration of conformity for conveyor technology machines that is ready for signature. Due to many moving machine parts and the associated danger of being pulled in or crushed, special focus had to be placed on user safety

Considers, among others: 2006/42/EG, 2004/108/EG, 2006/95/EG, EN 620, EN 618:2002+A1, EN 617 2001+A1, etc.

CE marking and conformity assessment of a pipe drawing machine including risk assessment within the framework of occupational safety and preparation of an operating instruction

easyCE supports the entire conformity assessment process, including risk assessment, right up to the declaration of conformity ready for signature. EasyCE also supports various tasks within the scope of occupational safety. In addition to the regular requirements for machines, particular attention was paid to user safety due to the high risk of crushing and cutting of upper limbs. Occupational safety was of great importance due to the constant handling of drawing oil.

Considered among others: 2006/42/EC, 2014/30/EU, EN 13675:2010-10 etc.

CE marking for a roadheader underground mining

easyCE supports the entire conformity assessment procedure and CE marking for a roadheader for underground operations in coal mining. In the conformity assessment procedure, various safety devices (including safety valves, lowering protection, control circuits, other hydraulic components) were assessed and documented in accordance with the normative specifications. When selecting the material, requirements for maximum stability and maximum torsional rigidity had to be taken into account. The risk assessment was carried out in accordance with EN ISO 12100. Another machine in ATEX design was implemented by easyCE as a follow-up project.

Considered among others: 2006/42/EC, 2014/30/EU, EN 13675:2010-10 etc.

CE marking and conformity assessment of all life cycle phases of a tunnel boring machine for copper mining in Australia

easyCE supports the entire conformity assessment procedure, including risk assessment and the declaration of conformity ready for signature, for all life phases of a tunnel boring machine for copper mining in Australia. The completely new concept of using multi-arm cutting heads was particularly important during the procedure. In addition to the conventional regulations, special safety and technical requirements that apply in Australia were taken into account. Intensive cooperation with the manufacturer and its Australian client was required.

Takes into account, among others: 2006/42/EC, 2014/30/EU, 2014/68/EU, DIN EN 12111, DIN EN 474-1 etc.

Conformity of conveyor system and belt scraper for universal use, e.g. the transport of bulk materials in mining

easyCE supports the entire conformity assessment procedure including risk assessment according to ATEX up to the declaration of conformity ready for signature for conveyor belt scrapers in universal use. During the "assembly" and "maintenance" life cycle phases, special injury risks from heavy components had to be taken into account

CE marking for a test bench for pressure testing of low-pressure units in the pharmaceutical sector

The first challenge was to decide whether the Pressure Equipment Directive needed to be applied to this machine. With easyCE's guidance, the manufacturer was able to carry out some measurements on the machine, which ultimately meant that the Pressure Equipment Directive did not need to be applied. Although this made the process easier, a thorough risk assessment and the development of appropriate safety measures were still required within the usual framework. In particular, easyCE was able to verify and ensure the high hygiene standards of the pharmaceutical industry by accurately comparing them with EN ISO 14159, so that the CE conformity assessment process could be successfully completed and a CE marking for the test bench could be created.

Takes into account among others: Machinery Directive 2006/42/EC Annex I, EN ISO 14159

CE marking for awnings of all types

easyCE supports the entire conformity assessment procedure (including risk assessment) up to the declaration of conformity for awnings and the declaration of performance for construction products that is ready for signature. In this case, the Construction Products Regulation (EU) was also applied in addition to the Machinery Directive. Particular focus was placed on installation safety in connection with the special requirements for various fastening options and environmental conditions.

Takes into account, among others: Regulation (EU) No 305/2011 Annex III, EN 1090-3, EN 13561:2015-08 etc.

CE marking and conformity assessment of awnings and pergolas of all types

easyCE supports the entire conformity assessment procedure according to the Machinery Directive and the Construction Products Regulation up to the declaration of conformity for awnings and the declaration of performance for construction products, ready for signature. A special focus was placed on installation safety, in connection with the special requirements for various fastening options and adverse environmental conditions.

Takes into account, among others: Regulation (EU) No 305/2011 Annex III, EN 1090-3, EN 13561:2015-08 etc.

Conformity assessment for earthing fixed point in formwork-flush wall installation with lightning protection connection

A fixed earthing point for building waterproofing acts as a connection point for external lightning protection systems (LPS) and is classified as a construction product in accordance with the provisions of the Construction Products Regulation. In the event of current being introduced through the building, for example by lightning, the fixed earthing point discharges this via the ring conductor. In addition to the extensive conformity assessment, easyCE particularly highlights essential features such as the short-circuit test and proof of use as a connection for the LPS.

Taken into account, among others: Construction Products Regulation (EU) No. 305/2011, EN IEC 62561-1, EN IEC 62561-5

Conformity assessment for product series of decorative wallcoverings

Wall coverings offer decorative solutions for embellishing interior walls, with a wide selection of film variants and profile shapes made from different materials. The easyCE conformity assessment covers the entire process from individual products to complete series. In addition, easyCE indicates additional features to be considered: label and packaging design, fire behaviour and formaldehyde release.

Taken into account, among others: Construction Products Regulation (EU) No. 305/2011, EN 15102, EN 13986, EN 13245

Conformity assessment and CE marking of air conditioning systems in industrial plants and cooling plants, as well as preparation of operating instructions

easyCE supports the entire conformity assessment procedure including risk assessment according to ATEX up to the declaration of conformity ready for signature for air conditioning systems in industrial plants and air conditioning systems for recooling. Particular attention was given to the creation of a basic operating manual as a template for adaptation to special product variants. Due to the risk of legionella formation, the maintenance procedures had to be given special consideration in the risk assessment.

Considers, among others: 98/37/EG, 97/23/EG, 2006/95/EG, 2004/108/EG, 2014/68/EG, DIN EN 14705:2005-10, DIN EN 13741:2003-5, VDI 2047-1:1992-07

Procedure and risk assessment for maintenance work on wind turbines

easyCE supports the development of the procedural instructions and risk assessment for maintenance work when changing the gearbox oil in wind turbines. The high-altitude workplace meant that special challenges had to be taken into account during maintenance. For example, special focus had to be placed on the fall protection of the personnel and the proper use of the ground equipment when filling the oil.

CE marking for a small hydropower plant

easyCE carried out the entire conformity assessment procedure for a small hydropower plant consisting of a turbine, generator, hydraulic unit, control valves and control cabinet in a cavern. Through a targeted interface analysis, the small hydropower plant was clearly distinguished from additional safety requirements that could have applied due to the special location. This enabled the required compliance documentation to be drawn up quickly and successfully.

Taken into account, among others: 2006/42/EC, 2014/30/EU, 2014/35/EU, EN ISO 14120, EN ISO 4413

CE marking and conformity assessment of a vehicle silo for the transport of bulk materials

easyCE supports the entire conformity assessment procedure, including risk assessment, up to the declaration of conformity ready for signature for a horizontally operated transport silo for all types of bulk goods. Special requirements for user safety had to be observed when emptying the silo installed on the transport vehicle.

Considered among others: 2006/42/EC, 97/23/EC, 94/9/EC

CE conformity assessment of tractor attachments in agriculture and forestry

easyCE supports the entire conformity assessment procedure, including risk assessment, right up to the declaration of conformity for tractor attachments that is ready for signature. The high mobility of the product at and above head height meant that particularly high requirements were placed on user safety. To collect data on site, easyCE looked at the life cycle phases of 'assembly', 'operation' and 'maintenance' on comparable machines in operation. Overall, a high risk potential had to be taken into account due to highly mobile, heavy and unwieldy components.

Considered among others: 2006/42/EC, 2014/30/EU, 2014/68/EU, DIN EN 12525, EN ISO 14982, DIN EN 16590-2

CE marking for a trailer pump for transporting concrete

The CE marking for the trailer pump, a mobile device for transporting concrete, was particularly challenging. As this product was already sold outside the EU, the main focus was on checking and implementing the demanding EU safety regulations that apply to all types of machinery. The conformity assessment required a comprehensive risk assessment to identify potential hazards and determine appropriate safety measures and check their implementation. The challenge was to ensure compliance with a wide range of standards and regulations, ranging from the general Machinery Directive to specific C standards for the product. With the support of easyCE, the company was able to meet all the requirements to successfully obtain CE marking. Our team worked closely with the customer to ensure that the trailer pump met the EU's high safety standards without compromising the efficiency and performance of the product.

Considered among others: EN ISO 12100, EN 12001, EN ISO 4413

CE marking of Cat. 1 mouth-nose covering

easyCE supports the entire conformity assessment procedure including instructions for use for an everyday mask such as those currently in frequent use during the Corona pandemic. Rated as personal protective equipment of category 1.

CE marking for FFP2 mask

easyCE supports the entire conformity assessment procedure including instructions for use for an FFP2 mask in accordance with the Personal Protective Equipment Regulation. The mask serves to protect against the absorption and spread of bacteria and viruses when speaking, sneezing, coughing and generally when breathing. It is particularly important to note that PPE of a higher category, such as this FFP2 mask, require testing by a notified body such as TÜV as part of the conformity assessment procedure. easyCE helped with the organization and procurement of all necessary test reports.

Considered: 2016/425, EN 149:2001 + A1:2009

Conformity assessment, CE marking and instructions for use for a permeate treatment plant

easyCE supports the entire conformity assessment procedure, including the instructions for use for a system for permeate treatment, i.e. the treatment of water as a precursor to dialysis machines. In terms of design, it was important for the system to maintain and achieve a high degree of purity, which also had to be taken into account during the risk assessment.

Support with the CE marking of horn eyeglass frames (Class I medical device) and sunglasses

In a challenging project, easyCE ensured the conformity of horn eyeglass frames as accessories to medical devices under the Medical Devices Regulation 2017/745 and of sunglasses under the PPE Regulation 2016/425. We extended the technical documentation to ensure that all required documents such as the risk management plan and the post-market surveillance plan are included.

Our team worked closely with the client to ensure all requirements of the Medical Device Regulation were met, including the general safety and performance requirements set out in Annex I. This included a thorough review of the design and manufacturing requirements to ensure the products met the highest standards.

In addition, we supported the customer in registering in relevant systems to obtain necessary identifications such as SRN (via EUDAMED), DMIDS (via BfArM) and UDI-DI (via IFA). Our expertise and commitment enabled the customer to enter the European market smoothly and streamlined its compliance processes."

Taken into account, among others: Medical Device Regulation 2017/745, PPE Regulation 2016/425, EN ISO 20417:2021, EN ISO 14971:2019 + A11:2021, EN ISO 15223-1:2021, EN ISO 13485:2016 + AC:2018 + A11:2021, EN ISO 12312-1

CE marking for drug tests

In this specific case of a multi-drug test, the decision on CE marking requirements depends on the user group. While a drug test for law enforcement purposes is exempt, a drug test for medical purposes falls under the new Medical Device Regulations (EU) 2017/745 and In Vitro Diagnostics (EU) 2017/746 as a Class C product. In this project, easyCE adapts the schedule to the customer in a particularly flexible manner, as unexpected problems arise during production. Even after completion of the commissioned project (Technical File, Hazard Identification, Identification of Safety-Related Characteristics, GSPR File, Risk Management Plan, Declaration of Conformity) and handover to the customer, design changes to the product occur. easyCE adapts the conformity documents and advises on necessary changes to the technical documents. Finally, easyCE contacts notified bodies on behalf of the customer and accompanies the customer during registration in EUDAMED to obtain SRN and basic UDI-DI.

Takes into account, among others: Regulation (EU) 2017/745; Regulation (EU) 2017/746

CE marking for smart drinking bottle

easyCE supports the conformity assessment procedure and the preparation of an operating manual for a smart drinking bottle for storing and drinking liquid foods. In addition, the drinking bottle communicates as a mobile device with the appropriate water dispenser.

CE marking for intelligent water dispenser

easyCE supports the entire conformity assessment procedure including operating instructions for an intelligent water dispenser for use in private and public spaces. The wide range of functions of the device, including cooling and boiling tap water, filtering, cleaning and sparkling, were particularly important during the conformity assessment procedure.

Considered: Machinery Directive, EMC Directive, RoHS Directive, WEE Directive, Low Voltage Directive, numerous harmonized standards (e.g. DIN EN 894-1, DIN EN ISO 11200, DIN EN ISO 11688-1)