APPLICATION FOR AN EU TYPE-EXAMINATION AND CONFORMITY ASSESSMENT OF PERSONAL PROTECTIVE EQUIPMENT
We apply for an EU type-examination for the following personal protective equipment (PPE). (Fill out a separate application form for each product or product group and enclose the relevant technical documentation.)
This application together with the technical documentation and attachments including the confirmation of order by the Finnish Institute of Occupational Health (hereafter FIOH or Notified Body 0403) shall form the certification agreement between the applicant and FIOH.
Company name (applicant): / Click here to enter text. /Product name(s),number(s) or other identification information of product(s):
Type of product/product group:
Manufacturer and address of the manufacturer:
Authorized representative in Europe and
address of the representative:
Applicant declarations
a)We confirm that we have not submitted the PPE model of this application to any other notified body within the European Economic Area for EU type-examination.
b)We shall not modify the technical specification of the PPE of this application form, nor the user information, nor the additional technical information, without notifying FIOH (Finnish Institute of Occupational Health).
c)We shall notify FIOH, without delay, of changes that may affect our ability to conform with the certification requirements (e.g. the legal, commercial, organizational status or ownership, major changes to the quality management system, contact address, production sites, modification to the product or the production method).
d)We have taken into account the essential health and safety requirements given in Regulation (EU) 2016/425 Annex II for personal protective equipment and the harmonised European standards as given in the technical documentation of this application form when manufacturing or importing the PPE.
e)We shall provide, in the official language(s) of the EEA Member State of destination, identical translations of the wearer information and additional safety and technical information.
f)We acknowledge, that FIOH has the right to control the use of the certificate according to existing European regulations.
g)In case of refusal of EU type-examination certificate, we agree to the decision being announced to all notified bodies and to the Ministry of Social Affairs and Health in Finland.
h)We shall keep a record of complaints and corrective actions regarding the PPE in question.
i)We agree to have the PPE retested if needed, in case a relevant standard or its interpretation is altered.
j)If parts of the PPE come in contact with the wearer's skin, we declare that such parts are not known to cause skin irritation, allergic reactions or any other adverse effects on health.
k)We acknowledge, that FIOH has the right after the submission of the certificate to publish the name of the product and the certificate holder on the list of certified products.
l)We as the holder of the certificate acknowledge that we can publish or give clients the certificate without asking the permission to do so from FIOH. The holder of the certificate is however not obligated to provide his/her clients the certificate, only to the competent authority upon request.
m)We agree to stop using NB number 0403, if the certificate is withdrawn.The certificate may be withdrawn, if misuse is discovered. For example, not paying the invoices concerning the testing/certification, forging a certificate or misleading use of the certificate in advertising will be considered as misuse. The withdrawal along with argumentation will be delivered in writing. The Ministry of Social Affairs and Health of Finland and other notified bodies will be informed of the withdrawal.
n)We commit ourselves to keep the technical documents and the EU declaration of conformity at the disposal of the competent authorities for ten (10) years following the placing of the PPE on the market.
o)We commit ourselves to pay the certification expenses according to the price list.
p)We will take into account the 5 years validity of the certificate and the renewal guidelines.
q)We acknowledge that for marketing and advertising purposes, the name of the Finnish Institute of Occupational Health can be mentioned when referred to the Notified Body responsible for the EU type-examination of a product or products. Other use of the name of the Finnish Institute of Occupational Health is allowed only with a written authorization.
r)We acknowledge and agree that the General Terms and Conditions of Specialist Advisory Services of the Finnish Institute of Occupational Health (Appendix 1) shall be applied as applicable to certification services. However, the terms of this application and the confirmation of order by FIOH shall prevail.
The following documents are enclosed by the applicant in this application (The information given by the applicant shall serve as the basis for the assessment by FIOH):
List of technical documentation / Document ID and date☐Assessment of the risks against which the PPE is intended to protect from / Click here to enter text. /
☐Thereferences of the applied harmonized European standardsand/or list of the essential health and safety requirements applied
☐Description of other technical specifications that have been applied(if harmonized standards have not been applied)
☐Product design or manufacturing drawing, sketch or photo and sample of the PPE model
☐Material list, material specifications
☐Test reports or test certificates (issued by accredited laboratory)
☐User and safety information
☐Draft of CE markings and other product markings
☐Overview of production and product control or copy of an accredited quality system certificate
☐Other documents
I confirm that I have read and understand the applicant declarations and to the best of my knowledge, the information given in this application and in the enclosures theretois correct.
Company name (applicant) / DateClick here to enter text. / Click here to enter a date. /
Address: street name, building number / Signature
Postal code, name of the city or town / Name, in capital letters
Country / Position
Invoicing address (if other than above) / Contact person (if other than above)
VAT number / Telephone(s)
/ Finnish Institute of Occupational Health / Postal address: PL 40, FI-00032 Työterveyslaitos, Finland / Tel: +358 304741
Fax: +358 30 474 2115
e-mail:
Street address:Topeliuksenkatu 41b, FI-00250 Helsinki, Finland
Notified body No. 0403
Certification body S039 / VAT: FI 02202669