Request for Proposal (RFP) for the Establishment of Long-Term Agreement (LTA) with Supplier/s of Infection Prevention Supplies

New clarification added: Clarification No. 28Question Dear UNOPS,Thank you for listening to our recommendations and questions. We hereby submit a final request for a 7-day extension of the deadline to accommodate the updated requirements.AnswerPlease refer to Amendment No. 3 

New clarification added: Clarification No. 27Question  Dear Evaluation-Team,please find below our request for clarification:LOT 1, Pos. 3:You requested "Respirator with 2 headbands (upper and lower- not to tie)". Would you agree with a mask with elastic ear loops or with two headbands to tie. The mask with an upper and lower headband - not to tie - ist not available on the market.LOT 1, Pos. 19:Would you agree if the product only has a binding band for the back/waist?LOT 1, Pos. 24:Do you also agree with PP as material?What do you mean with "High opening of about 18 cm with strong rubber band."? Do you mean the opening of the shoe cover or the height of the shaft (shall the producte be more like a bootie)?Would you agree with white color?Thank you very much for your efforts.AnswerLOT 1, Pos. 3:Disposable protection mask for patient (2 headbands) (Lot 1, Item 3): The minimum requiremsnt for respirator can be with 2 earloops (NOT to tie) or 2 headbands (upper and lower- NOT to tie) . Please refer to Amendment No. 3.LOT 1, Pos. 19:The back can remain open with tie strips for securing, while the neckband can be an integral part of the apron design, eliminating the need for separate neck tiesLOT 1, Pos. 24Disposable non-woven shoe covers (Lot 1, Item 24) and disposable non-woven hair caps (Lot 1, Item 25) can be made of Polypropylene (PP). Please refer to Amendment No. 3The 'high opening of about 18 cm' specifies the diameter or circumference of the shoe cover's elastic opening, which ensures it can stretch adequately to fit over various shoe sizes. It does not refer to the height or shaft length of the shoe cover itselfThe minimum requirement is blue color.

New clarification added: Clarification No. 26QuestionRegarding: (16-18) Disposable laboratory gown:It is unclear if the requirement: "Compliant to AAMI PB70 (Level 1–3) and ASTM F3352; EN 13034" should be read as:"Compliant to AAMI PB70 (Level 1–3) and ASTM F3352 AND EN 13034" or "Compliant to AAMI PB70 (Level 1–3) and ASTM F3352 OR EN 13034".In case it should be read as "AND" we have the following comments:ASTM F3352 provides the "Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities" and is the correct standard for this product. It refers to ANSI/AAMI PB 70 for the 4 levels of protection.EN 13034 is the standard for "Protective clothing against liquid chemicals" and does not specifically apply to gowns. It is not common for gown manufacturers to have EN 13034.We request UNOPS to remove EN 13034 as a requirement. If UNOPS decides to keep EN 13034 as a minimum requirement, it should at least add the corresponding ASTM F739-12 standard as an alternative test method, in the same way as ISO 16604 Class 5 is added as an alternative to ASTM F3352.ASTM F739-12 is commonly used among gown manufacturers, as it is the standard/test method accepted by the US FDA. For this reason, UNOPS should accept the standard as an alternative to EN 13034.We suggest to modify the requirements as follows: "Compliant to AAMI PB70 Level 4 and ASTM F3352 or ISO 16604 Class 5; EN 13034 - Type PB [6] or ASTM F739-12"This modification will ensure maximum competition and compliance.AnswerPlease refer to Amendment No. 3

New clarification added: Clarification No. 25QuestionRegarding 23. Reusable Face Shields:It is stated that the thickness should be 0.37mm. Please clarify if this is the exact required thickness or a minimum thickness. High-quality reusable face shields are usually more than double that thickness.AnswerThe thickness of the item 23. Reusable Face Shields is minimum 0.37 mm. Please refer to Amendment No. 3

New clarification added: Clarification No. 24QuestionRegarding: Disposable protection mask for patient (2 headbands)It is very uncommon that EN 14683 surgical protection masks have 2 headbands (not to tie).Usually, EN 14683 surgical protection masks EITHER have earloops OR have 2 headbands TO TIE. We are unaware of any manufacturers making 2 headbands (not to tie) - neither can we find any when searching Google.AnswerDisposable protection mask for patient (2 headbands) (Lot 1, Item 3): The minimum requirement for respirator can be with 2 earloops (NOT to tie) or 2 headbands (upper and lower- NOT to tie). Please refer to Amendment No. 3Please consider completely removing the requirement "Not to tie" or add this as an optimal requirement, and not a minimum requirement.

New clarification added: Clarification No. 23QuestionRegarding: Disposable laboratory shoe covers & Disposable laboratory hair coversPlease confirm whether you are looking for NON-WOVEN or POLYETHYLENE (PE).These are two very different materials. NON-WOVEN feels like fabric, and POLYETHYLENE feels like plastic.AnswerDisposable non-woven shoe covers (Lot 1, Item 24) and disposable non-woven hair caps (Lot 1, Item 25) can be made of Polypropylene (PP). Please refer to Amendment No. 3 

New clarification added: Clarification No. 22Question  Regarding Disposable Gloves:ASTM D3578 does NOT apply to Nitrile Gloves, only to Latex Gloves. ASTM D3578 refers to gloves made of Natural Rubber Latex and not Nitrile Butadiene Rubber. The corresponding ASTM standard for Nitrile Gloves is ASTM D6319 (which only applies to Nitrile Gloves and NOT Latex Gloves).We request that UNOPS remove ASTM D3578 for product 7,8 and 9.AnswerPlease refer to Amendment No. 2 and also reflected in Amendment No. 3Please refer to Amendment No. 2 and also reflected in Amendment 3Here is a link to the standard. It confirms that the standard is only for Natural Rubber Gloves: https://www.astm.org/d3578-19.htmlWe also propose that UNOPS extend the deadline by one week to enable the suppliers to adjust to the newly announced amendments.  

New clarification added: Clarification No. 22Question  Regarding Disposable Gloves:ASTM D3578 does NOT apply to Nitrile Gloves, only to Latex Gloves. ASTM D3578 refers to gloves made of Natural Rubber Latex and not Nitrile Butadiene Rubber. The corresponding ASTM standard for Nitrile Gloves is ASTM D6319 (which only applies to Nitrile Gloves and NOT Latex Gloves).We request that UNOPS remove ASTM D3578 for product 7,8 and 9.AnswerPlease refer to Amendment No. 2 and also reflected in Amendment No. 3Please refer to Amendment No. 2 and also reflected in Amendment 3Here is a link to the standard. It confirms that the standard is only for Natural Rubber Gloves: https://www.astm.org/d3578-19.htmlWe also propose that UNOPS extend the deadline by one week to enable the suppliers to adjust to the newly announced amendments.  

New clarification added: Clarification No. 22Question  Regarding Disposable Gloves:ASTM D3578 does NOT apply to Nitrile Gloves, only to Latex Gloves. ASTM D3578 refers to gloves made of Natural Rubber Latex and not Nitrile Butadiene Rubber. The corresponding ASTM standard for Nitrile Gloves is ASTM D6319 (which only applies to Nitrile Gloves and NOT Latex Gloves).We request that UNOPS remove ASTM D3578 for product 7,8 and 9.AnswerPlease refer to Amendment No. 2 and also reflected in Amendment No. 3Please refer to Amendment No. 2 and also reflected in Amendment 3Here is a link to the standard. It confirms that the standard is only for Natural Rubber Gloves: https://www.astm.org/d3578-19.htmlWe also propose that UNOPS extend the deadline by one week to enable the suppliers to adjust to the newly announced amendments.  

New clarification added: Clarification No. 22Question  Regarding Disposable Gloves:ASTM D3578 does NOT apply to Nitrile Gloves, only to Latex Gloves. ASTM D3578 refers to gloves made of Natural Rubber Latex and not Nitrile Butadiene Rubber. The corresponding ASTM standard for Nitrile Gloves is ASTM D6319 (which only applies to Nitrile Gloves and NOT Latex Gloves).We request that UNOPS remove ASTM D3578 for product 7,8 and 9.AnswerPlease refer to Amendment No. 2 and also reflected in Amendment No. 3Please refer to Amendment No. 2 and also reflected in Amendment 3Here is a link to the standard. It confirms that the standard is only for Natural Rubber Gloves: https://www.astm.org/d3578-19.htmlWe also propose that UNOPS extend the deadline by one week to enable the suppliers to adjust to the newly announced amendments.  

New clarification added: Clarification No. 21QuestionThe field "Supplier (Offeror) Name:" (A3) in "03_v01_Section III_Annex 1_Form C_Technical Proposal Form_RFP_2024_54109.xlsx" is protected, and it is not possible to enter the Offerors name.AnswerPlease refer to Amendment No. 3

New amendment added #3: Amendment No. 3In General Tab1. The deadline has been updated.  In the Documents tab:1. The file 03_v02_Section III_Annex 1_Form C_Technical Proposal Form_RFP_2024_54109.xlsx is replaced by the file 03_v03_Section III_Annex 1_Form C_Technical Proposal Form_RFP_2024_54109.xlsxIn the v01 files the new text has been marked with green text while the red strikethrough text corresponds to the deleted text.Please see the changes in:Lot 1, items 3, 16, 17, 18, 19, 23, 24 and 25

New clarification added: Clarification No. 20QuestionRegarding Latex and Nitrile examination gloves:Nitrile: A good-quality nitrile examination glove would have specifications of 0.09mm +—0.02mm at the fingertip and 0.07mm +-0.02mm at the palm. The specification in the tender is 0.10mm with no mention of palm or fingertip.Latex: Due to the properties of the raw material a latex glove has to be thicker to comply with the same medical standard. A good-quality latex examination glove would have specifications of 0.11mm +—0.02mm at the fingertip and 0.10mm +-0.02mm at the palm. The specification in the tender is 0.10mm with no mention of palm or fingertip.Question 1: Is it a mistake that the same thickness is required for both nitrile and latex examination gloves? (the specifications seem to have been copied from the latex gloves)Question 2: Should the thickness be measured at the palm or the fingertip?Question 3: Should the thickness be considered the minimum thickness or the average thickness? (see an example of average thickness above)Answer1. The requirement for the thickness for both nitrile and latex gloves has been corrected. Please refer to Amendment No.22. The thickness is measured at both the palm and finger based on standard test methods as a representative area for overall glove thickness.3. Please consider the thickness requirement and please also refer to Amendment No.2 

New amendment added #2: Amendment No. 2In General Tab1. The deadline for clarifications has been updated. In the Documents tab:2. The file 03_v01_Section III_Annex 1_Form C_Technical Proposal Form_RFP_2024_54109.xlsx is replaced by the file 03_v02_Section III_Annex 1_Form C_Technical Proposal Form_RFP_2024_54109.xlsxIn the v01 files the new text has been marked with green text while the red strikethrough text corresponds to the deleted text.Please see the changes in:Lot 1, items 4, 5, 6, 7, 8, 9

New clarification added: Clarification No. 19QuestionRegarding packaging dimensions:Should the packaging dimensions and weight correspond to the unit of measure or the transportation carton?For disposable respirators N95, the unit of measure is "Pack of 20 units." However, these packs of 20 units are then packed in a transportation carton, which could typically be ten packs per transportation carton.Does UNOPS want to know the size and weight of the "unit of measure" or the transportation carton? AnswerThe packaging dimensions and weight correspond to the unit of measure.For disposable respirators N95, the unit of measure is defined as a "pack of 20 units," meaning each pack contains 20 individual respirators.UNOPS wants to know the size and weight of the "unit of measure"

New clarification added: Clarification No. 18Question  Dear Sir ; I hope that you are doing well. Could you please give us an answer for the below queries :What is the requested period of the Long- Term agreement (LTA) ?Is it possible for the supply to be for the Palestinian areas Ramallah OR Jerusalem?Waiting your reply as soon as possible. Thanks,AnswerUNOPS/StopTB-GDF will sign with awarded supplier(s) three-years (3-years) Long-Term Agreement(s) (LTA(s) for the provision of the Infection prevention supplies, with an option torenew the LTA for two additional periods of one (1) year each, under the same terms and conditions for a maximum total of five (5) years based on demonstrated good performance ofsupplier(s) under LTA(s). Please refer to Additional information in the Tender Particulars tab of eSourcing and Section 2 of Section II Schedule of requirements available on the Documents tab of eSourcing. Please refer to the Tender Particulars tab of eSourcing "Additional information" and Section 2 of Section II Schedule of requirements available on the Documents tab of eSourcing.Once LTA/s are signed with awarded supplier/s, the Interferon Gamma Release Assay (IGRA) for the detection of latent TB will be introduced into the GDF catalog. Any country in the world is eligible to purchase via UNOPS/StopTB-GDF as long as it is in alignment with national rules and regulations. 

New clarification added: Clarification No. 17QuestionDear UNOPS,Are we to state the FCA delivery points directly in the financial proposal or we are state them in the questionnaire.Thank youAnswerThe FCA delivery points should be indicated in Column I: "FCA Point(s) of delivery for offered products(Exact address: street, city, Country)" of Annex 2_Form D_Financial Proposal Form available in the Documents tab of eSourcing. 

New clarification added: Clarification No. 16QuestionDear Ladies and Gentlemen,here our requests for clarification:Lot 2 - Pos. 29: Is this item for occupied or unoccupied rooms (discrepancy between “GDF Product Name” and “Product Technical Specifications: Minimum Requirements”)Lot 3 - Pos. 54: Do you need a ready to use solution or a concentrate?What kind of document is requested/What do you mean with “Manufacturing License Issued by the National Regulatory Agency in the country of Manufacture. Please provide a number and expiry date of the license“ (Requested in Form C – Technical Proposal Form (Manufacturer QA Information of product offered)).Furthermore we kindly ask you to extend the submission deadline for two more weeks. Several suppliers/manufacturers were not available due to MEDICA fair and public holidays which leads to considerable delays.Thank you very much in advance for your feedback.Answera. Lot 2 -Pos 29: Please refer to Amendment No.1b. Lot 3 - Pos. 54: It is a ready to use solutionc. The required document, Manufacturing Licence, is a document of registration/approval of the relevant manufacturing sites and activities performed, issued by the National Regulatory Authority (NRA) of the country where the product is manufactured.d. Please refer to Amendment No.1 

New clarification added: Clarification No. 15QuestionDear Sir/Madam,We have the following questions for Items from LOT 1 PPE only:* Item 2: please confirm the certification of either EN149 FFP2 or the medical standard EN 14683 IIR. Both together are not possible.* Item 7/8/9: are both EN 473 (EU norm) and ASTM classification required?* Item 21: it is possible to provide goggles that are certified in US and EU, but it will only be marked EN in EU and ANSI in US. It will be the same model, but not having both markings on 1 goggle.  Please confirm that 1 certification will be acceptable.* Item 23: most of the disinfectans/solvents will damage the screen. Could the requirement for cleaning and disinfection be removed? * Item 19/20/24/25: requirement for biodegradabilty --> most of the products on the market are made of SMS/CPE which are plastics and which may degrade “faster” they don’t fully compost or degrade. Could this requirement be revised/removed?Thank you in advace.Answera. Item 2: Based on the intended use, it should conform to both standards as stated.b. Item 7/8/9: The minimum requirement is to be compliant with EN 455 parts 1-4, EN 374, and the optimal requirement is to be compliant to: ASTM D6319. Yes, gloves can comply with both EN and relevant ASTM standards. Please refer to Amendment No. 1c. Item 21:Yes it is possible as long as the item fully complies with either or both of the standards. Please refer to Amendment No.1d. Item 23: Please refer to the minimum technical specifications item 5: Made of robust material which can be cleaned and disinfected) or disposable. The requirement for cleaning and disinfection can not be removed.e. Item 19/20/24/25: The optimal requirement of Material to be Biodegradable or compostable material, will not be revised/removed. The biodegradable plastic is an optimal requirement because it aligns with the goals of sustainability, responsibility, and long-term environmental health by ensuring no lingering pollution or ecological harm. 

New amendment added #1: Amendment No. 1In General Tab1. The deadline for clarifications has been updated. 2. The deadline has been updated.  In the Documents tab:1. The file 03_v00_Section III_Annex 1_Form C_Technical Proposal Form_RFP_2024_54109.xlsx is replaced by the file 03_v01_Section III_Annex 1_Form C_Technical Proposal Form_RFP_2024_54109.xlsxIn the v01 files the new text has been marked with green text while the red strikethrough text corresponds to the deleted text.Please see the changes in:Lot 1, items 7, 8, 9, 21Lot 2, items 29

New clarification added: Clarification No. 14QuestionDear Sir/Madam,For better preparation of the bidding, we sincerely hope that you could agree to extend the validity period of the bid until November 30th, 2024.Thank you so much for your understanding and support!Best regards,AnswerThe request of an extension for bid submission is not accepted.All offers should be submitted through eSourcing before the Deadline indicated in the General Tab of eSourcing 

New clarification added: Clarification No. 13QuestionPlease let us know how dose the units prices for some products mean？For example：Disposable respirators N95，Unit of measure is “Pack of 20 units”.Please let me know if our FCA price should be for a Pack(20 units) or for a unit?AnswerThe FCA Unit Price should correspond to the unit of measure being offered. If your offer matches the required unit of measure (for example, a "Pack of 20 units"), the FCA Price should be based on that pack size. If your offer is for a different unit of measure, such as a "Pack of 25 units," then the FCA Price should reflect the pack of 25 units.Please refer to Section II, Schedule of Requirements, Section 3.2: The Offeror is requested to supply the product in the pack size indicated in the “Unit of Measure” in Annex 1_Form C_Technical Proposal Form_RFP_2024_54109. If the Offeror does not have the required pack size, they may offer a similar pack size close to the requested one. However, UNOPS/Stop TB-GDF reserves the right to reject any offered pack size that significantly deviates from the requested specification.Also, refer to Section IV, Evaluation Criteria, Section 6.2: For the financial evaluation of the Lot, if a different pack size is offered than the one requested, the item cost in the Lot for evaluation purposes will be calculated based on the cost per unit multiplied by the requested quantity in the pack size specified in Annex 1_Form C_Technical Proposal Form_RFP_2024_54109.

New clarification added: Clarification No. 12QuestionDear UNOPSWe request an extension of the date for submitting offers as we are still waiting for a response from suppliers and manufacturers in order to submit bids for as many lots as possible.We remain attentive.Best regards.AnswerThe request of an extension for bid submission is not accepted.All offers should be submitted through eSourcing before the Deadline indicated in the General Tab of eSourcing. 

New clarification added: Clarification No. 11Question Dear UNOPSPlease confirm whether it is allowed to have several suppliers in different parts of the world for the same batch, in order to facilitate purchasing, logistics and optimize delivery times.We remain attentive.Best regards.AnswerPlease note that in Tender Particulars is stated that Alternative proposals are not accepted. Therefore Offerors shall not submit more than one Proposal per product/Lot. Please refer to Section I, Article 15 and Tender Particulars.If a product offered has more than one manufacturing site, the information of all manufacturing sites must be included in Annex 1_Form C_Technical Proposal, and related supporting documentation requested in the Form H Checklist (available in Section III Returnable Bidding Forms) must be submitted.

New clarification added: Clarification No. 10Dear UNOPSWhen analyzing the questions requested for the offer on the esourcing platform, we see that you are requesting the certificate of authorization for distribution by the manufacturer, Annex G. We would like to ask if, in the event that we are not the importers of said product, we can send the distribution chain, that is, the complete Annex G from the manufacturer to the importer and a certificate from the importer authorizing us to market their products.We remain attentive.Best regards.AnswerPlease refer to Secction II Schedule of requirements, section 3.6, letter c.: "In case Offeror is not the manufacturer of an offered product, Offeror should demonstrate that he is duly authorized by the manufacturer of the offered product to participate in this RFP by providing the ‘Form G: Manufacturer’s Authorization Form’ duly completed and signed by the manufacturer. The absence of the Form G will lead to the rejection of the offered product from this RFP evaluation process".Form G must follow the template provided in Section III Returnable Bidding Forms available on the Documents tab of eSourcing.

New clarification added: Clarification No. 9QuestionDoes LOT1 need samples? I didn't see the description of the sample in the documents, thanks.AnswerNo Samples are required.Please refer to Section III Returnable Bidding Forms, Form H for the documentation required for each lot.

New clarification added: Clarification No. 8QuestionRegarding the Lot 1: PERSONAL PROTECTIVE EQUIPMENT (PPE), could we only bid some items not all?And do you have any estimated purchase quantity?AnswerPlease refer to Clarification No.3

New clarification added: Clarification No. 7QuestionDo you have reference pictures for each product of LOT1? Thanks.AnswerNo pictures are available for any of the products included in the 4 lots of this tender. Please submit your proposal with product technical specifications that meet at least the minimum technical specifications requirements as specified in the Section III_Annex 1_Form C_Technical Proposal Form_RFP_2024_54109 to be considered for evaluation 

New clarification added: Clarification No. 6QuestionDear Sir/Madam,We are pleased to offer the products for this bid (Ref: RFP/2024/54109). However, may we request the specific dimensions for the products in LOT 1, 13-15, Cotton laboratory coat size S/M/L, inclusive of specifications, such as fabric weight, measured values, and pocket dimensions, to ensure compatibility and superior quality standards?Due to the time required for collecting and transmitting specific product parameter information to the factory and receiving their corresponding feedback, we kindly request for a two-week extension on this request for proposal. We look forward to hearing from you regarding this request.Best regards.AnswerThe tender was issued with generic technical specifications to provide Offerors with the flexibility to propose a variety of solutions. However, the product/s offered shall meet at least the minimum requirements stated to be considered for evaluation. Please submit your proposal with product technical specifications that meet at least the minimum technical specifications requirements per product offered as specified in Section III_Annex 1_Form C_Technical Proposal Form_RFP_2024_54109.The request of an extension for bid submission is not accepted.All offers should be submitted through eSourcing before the Deadline indicated in the General Tab of eSourcing.

New clarification added: Clarification No. 5QuestionDear Sir/Madam,For the question we mentioned on 30th October, any response there?Kinldy await your reply.AnswerPlease refer to the clarifications posted in the Revisions tab under the Tender Information tab in eSourcing.According to Section I Article 7, UNOPS shall gather all requests for clarification and may respond in writing to all such requests at the same time. Responses to requests for clarification shall be posted through the UNOPS eSourcing system. 

New clarification added: Clarification No. 4Question  Dear Sir/Madam,I hope this message finds you wellWe are pleased to provide the following product technical specifications (Optimal Requirements) for Product 19 named Disposable plastic aprons in LOT1: Material: Biodegradable or compostable material with product performance testing if biodegradable (EN 13432 and ASTM  D6400) applies exclusively to the raw material, or is it also necessary for the entire completed product to meet this standard? Looking forward to your reply. Best regards.AnswerThe optimal requirement is for the entire completed product 

New clarification added: Clarification No. 3Question DDear Sir/Madam,Regarding the Lot 1: PERSONAL PROTECTIVE EQUIPMENT (PPE), could we only bid some items not all?And do you have any estimated purchase quantity?AnswerNo. Offerors MUST offer 100% of GDF’s requested products within a Lot for their Proposal to be considered. Please refer to Section 3.2 of Section II Schedule of Requirements available on the Documents tab of eSourcing.UNOPS/StopTB-GDF cannot provide forecasts or guarantee quantities to be purchased per product and country for the period of the LTA resulting of this RFP. However, you can refer to the historical data of quantities purchased in Annex 3. Please refer to Section 3.5 of Section II Schedule of Requirements available on the Documents tab of eSourcing. 

New clarification added: Clarification No. 2QuestionUNOPS,I hope this message finds you well. I am writing to request clarification regarding the Incoterms specified for delivery under the LTA for the tuberculosis program. We would like to confirm the specific Incoterms applicable for the deliveries, as it is not explicitly detailed in the documents.Additionally, could you kindly confirm whether it is required to provide delivery services to all listed countries under the program, or if it is acceptable to submit a proposal covering a partial list of member countries?Thank you very much for your assistance and for any guidance you can provide on these points. We look forward to your response to ensure our proposal aligns fully with program requirements.Answer1. The Incoterm applicable is FCA. Please refer to Section III Annex 2 Form D Financial Proposal Form available on the Documents tab of eSourcing.2. Annex 4 presents the list of countries where GDF has made deliveries and the objective of the LTA is to cover worldwide. However, in Q8 of the questionnaire, you must indicate in which countries your organization cannot deliver and why.

New clarification added: Clarification No. 1QuestionDear Sir,As per clause 19 Copy of valid regulatory authority certificate for the products classified as medical device and/or IVD from at least one of the following 5 regulatory authorities: EU, US FDA, Australia Therapeutic Good Administration, Health Canada, Japan Pharmaceutical and Medical Devices Agency) for the appropriate risk classification and intended use.PLEASE CONFIRM FOR LOT 3 AND FOR EUROPEAN CERTIFICATE IS MANDATORY ?AnswerYes, for the products in LOT 3 that fall within the definition and intended purpose of a medical device/IVD, this requirement is applicable. Please refer to Section 3.3 of Section II Schedule of requirements available on the Documents tab of eSourcing.