By the published Official Journal of the European Union on the 31.3.2016., CE PPE certification regulation is adopted the new Regulation (EU) 2016/425 which was approved on the 9 March 2016. The main changes summarized as following:
Directive 89/686/EEC is repealed with effect from 21 April 2018.
EC 89/686/EEC type-examination certificates (Article 10) remain valid until 21 April 2023. (unless they expire before that date.)
EU type-examination certificates
EC Type-examination certificates issued under Article 10 of 89/686/EEC are renamed as EU type-examination certificates and will be issued under Module B in Annex V. These will have a validity of five years.
Conformity assessment procedures
For each PPE product, the publicly available EU declaration is required. PPE product examination regulation of Category III:
EU type-examination (module B) set out in Annex V, and either of the following:
(i) conformity to type based on internal production control plus supervised product checks at random intervals (module C2) set out in Annex VI. (this is equivalent to the old Article 11A)
(ii) conformity to type based on quality assurance of the production process (module D) set out in Annex VIII. (this is equivalent to the old Article 11B)
To adapt these new regulations, ULTITEC will comply with all the new modification of regulations and ensure our product quality meets the latest EU standards. All partners can rely on our professional service and trust the cooperation relationship with us!