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Package No. 1 - Creped Paper For Sterilization. A Detailed Description Of The Subject Of The Order Is Attached As Annex No. 3 To The Swz - Assortment And Price Form. 1) In Packages No. 1-3, 5-8, The Ordering Party Requires That The Offered Medical Products Meet The Requirements Of The Act Of April 7, 2022. On Medical Devices (Journal Of Laws 2024.1620, I.E. Of 2024/11/05, As Amended), Regulation Of The Minister Of Health Of November 5, 2010 On The Method Of Classifying Medical Devices (Journal Of Laws Of 2010, No. 215, Item 1416), Regulation Of The Minister Of Health Of February 17, 2016 On Essential Requirements And Compliance Procedures For Medical Devices (Journal Of Laws Of 2016, Item 211), Regulation (Eu) 2019/1020 Of The European Parliament And Of The Council Of 20 June 2019. On Market Surveillance And Product Compliance - To The Extent Applicable And In Accordance With Directive 93/42/Eec And Had Certificates Allowing For Use On The Medical Market In Force In Poland And The European Union (E.G. Ce Declaration Of Conformity, Ec Declaration Of Conformity), Regulation Of The European Parliament And Of The Eu Council 2017/745 Of April 5, 2017. (Mdr).2) In Packages No. 1-3, 5-8, The Ordering Party Allows Class I Medical Devices That Can Be Placed On The Market Or Put Into Service (Until May 26, 2024), The Declaration Of Conformity Of Which Was Prepared Before May 26, 2021, And The Conformity Assessment Procedure In Accordance With The Mdr Regulation Requires The Participation Of The Entity, Provided That From May 26, 2021 They Remain In Line With The Existing Directive 93/42/Eec And No Significant Changes Are Foreseen In Their Design And Application.3) Whenever The Content Of The Swz, In The Scope Of The Description Of The Item, Mentions The Type/Trademark, Origin, Standard, Etc., It Is Assumed That Such Indication Is Accompanied By The Word Or Equivalent. The Ordering Party Will Consider Equivalent Equipment To Be The One That Has The Same Or Better Technical And Quality Parameters Than Those Described In The Swz, And Its The Use Will Not In Any Way Affect The Proper Functioning Of The Product In Accordance With Its Intended Purpose.4) When Describing The Subject Of The Order, The Ordering Party Has Specified In Detail The Equipment Consistent With Its Needs. However, The Ordering Party Also Allows For The Submission Of Equivalent Offers With Parameters Not Worse Than Those Specified By The Ordering Party, If The Description Of The Subject Of The Order Could Indicate That The Subject Of The Order Has Been Specified By Indicating A Trademark, Patent Or Origin, By Which The Ordering Party Understands Those That At Least Meet The Requirements Specified In The Above-Mentioned Annex And Are Characterized By The Same. Technical, Quality And Operational Parameters Not Worse Than Those Specified In The Description Of The Subject Of The Contract. 5) The Contractor Who Offers Equivalent Solutions Described By The Ordering Party Is Obliged To Attach To T
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