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The Conformity Assessment usually involves an audit of the manufacturer’s quality system (QMS) and, depending upon the device classification, a review of the relevant technical documentation provided by the manufacturer in support of the Safety and Performance Requirements (EU) or Essential Requirements (UK) for the device. A separate EU echnical documentation t assessment certificate will be issued upon successfully passing the assessment. Device description and specification, including variants and accessories. M. Make sure your product satisfies applicable EU requirements and mark CE on the product. Jun 2, 2020 · News: June 02 2020. 3 days ago · The main purpose of technical documentation in the EU Medical Device Regulation (MDR) is to prove that a medical device meets the general safety and performance requirements. The elements included in the documentation depend on the nature of the product and what is considered necessary, from a technical point of view, to demonstrate the compliance of the product with the essential requirements of the relevant Union harmonisation legislation or with harmonised standards, if these have been applied, indicating the essential requirements covered by the standards. Marking of Conformity on the products concerned conforming to the required Technical Documentation and meeting the provisions of the EU- Regulation which apply to them: 0344 Supplement to certificate: 2198606CN DEKRA hereby declares that the above mentioned manufacturer fulfils the relevant requirements of EU Regulation Scope. It is the manufacturer’s responsibility to carry out the conformity assessment This document has been developed to improve the assessment of the technical documentation by SGS NB 1639, allowing you, as the legal manufacturer, to check that you are providing us with complete documentation. leeaint. 3 Ramsay Court, Kingfisher Way Hinchingbrooke Business Park Huntingdon PE29 6FY United Kingdom Tel: + 44 (0) 1480 432801 Fax: + 44 (0) 1480 436314 E-mail: mail@leeaint. To bring medical devices into the EU market, depending on the classification and chosen MDR the technical documentation should be developed and handled. Where the May 6, 2020 · The benefits of having a QMS Certificate include: Enhanced Credibility: The certificate provides external validation of an organization’s commitment to quality, which enhances its credibility and reputation among customers, stakeholders, and business partners. This document is, in turn, based on the lab test report. The processing of changes is based on the following regulatory provisions and guidances: Medical Device Regulation, Annex IX Chapter II Section 4. The manufacturer draws up and signs the declaration and states that the product fulfils DQS Medizinprodukte GmbH is a Notified Body according to Regulation (EU) 2017/745 of the Council concerning medical devices with the Identification Number 0297. It gives a clear and structured oversight regarding the medical device description for 3rd parties. Sep 15, 2023 · For the device: the EU technical documentation assessment certificate (under Annex IX). / 6 4 20. It will also be useful for Designating Authorities in monitoring the performance of their NBs in this area. Kriegerstr. 1. nl Company registration 09085396. Please note that devices covered by Annex IX Section 5 specific procedures must also have a current Annex IX (Section 1, 2, 3) certificate from SGS Belgium NV involving site audits. The legislation will set out the conformity assessment procedure that needs to be carried out for your product. Depending on the type of 47 medicinal product concerned, the notified body shall consult the European Medicines Agency or a 48. A significant stage of the CE marking process is to produce technical documentation for the product to provide evidence of conformity for the relevant legislation. The technical document is instrumental in the assessment of the conformity of the said appliance with the Directive’s requirements. The validity of this certificate can only be verified by the QR-code. 9). Requirements regarding the technical documentation are covered in Annex 2 and Annex Generate the Certificate. Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation: December 2023: MDCG 2020-13 - Word version: Clinical evaluation assessment report template: July 2020: MDCG 2020-10/1 Rev. While these are the documents and records that the EU MDR has identified as mandatory, it is important to note that this does not include any documented information necessary for the proper function of your Quality Management System. Following the completion of the technical documentation assessment, a certification decision is made, including final approval of the summary of safety and clinical performance. 8) NB Audit and assessment – sampling of technical documentation per category device Near-patient testing and self-testing IVDs require technical documentation assessment by NB4. Technical documentation contains detailed information about the medical device, its intended use, specifications, design Aug 10, 2022 · This page applies to the following areas: toys; pyrotechnics; recreational craft and personal watercraft; simple pressure vessels; electromagnetic compatibility viable option. EU type-examination is the procedure whereby a notified body ascertains and certifies that a device, including its technical documentation and relevant life cycle processes and a corresponding representative sample of the device production envisaged, fulfils the relevant Apr 26, 2024 · Medical Device Regulation, Annex IX Chapter II Section 4. For class IIb implantable devices exempted according to 52,4, the Article technical documentation must be also assessed for every device, but no additional Conformity assessment: ensure that the product satisfies all essential health and safety requirements applicable to it. This also applies to medical device manufacturers, for example. Aug 10, 2022 · The current position is that where a manufacturer has taken steps under an EU conformity assessment procedure prior to 31 December 2024 but the product has not been placed on the GB market by that If the application is successful, the Notified Body issues an “EU quality management system certificate” (2. Integral publication of this certificate and adjoining reports is allowed. The purpose of this document is to provide guidance to notified bodies on how to take into account MDSAP Medical Device Regulatory Audit Reports1 (from hereafter “MDSAP audit reports”) issued by MDSAP auditing organisations2 when performing surveillance audits under Regulation (EU) 2017/745 – Medical Devices Regulation (MDR) and Jan 3, 2024 · The notified body will issue an EU technical documentation assessment certificate (Article 44) which has a limited time validity and can be suspended or withdrawn by the notified body. whether a supplement to the EU certificate for the assessment of the technical documentation could be issued. ) or in case of NA include justification Check off 3. However, the Medical Device Regulation (MDR) EU 2017/745 and In Vitro Diagnostic Regulation (IVDR . The document contains. EADs are the basis for issuing European technical assessments. 27, 29, 31 (UDI / Eudamed) All MPDG §8, §96, §97 All ISO 13485:2015, Sections 4. A certificate is issued following the NB QMS audit, and a second certificate is issued for every device after the review of the associated Technical Documentation. DEKRA Certification B. CERTIFICATION REVIEW. TD assessment is a critical element of conformity assessments under both the Directives and Regulations. T +31 88 96 83000 www. This supports an efficient and timely assessment of your submitted TD at TÜV SÜD premises. 1: Guidance on safety reporting in clinical investigations Appendix: Clinical investigation summary safety report form B) Product (certificate) EU Technical Documentation Assessment Certificate: Change to the approved design of a device or of its intended purpose or claims made for the device. They are responsible for checking that their products meet EU safety, health, and environmental protection requirements. Checklist Essential Requirements IVDD 98/79/EC. Three things are required for any Technical Documentation review: Context (i. O. In the latter case, DEKRA Certification GmbH assesses the planned changes, informs the manufacturer of its decision and, if the changes have been approved, issues a supplement to the EU certificate on the assessment Apr 17, 2021 · Step 5: Compile the technical documentation. The manufacturer shall establish, document and implement a quality management system as described in Article 10 (9) and maintain its effectiveness throughout the life cycle of the devices Nov 5, 2021 · Based on these assessments, the notified body shall then determine whether both the quality management system and the technical documentation satisfy the requirements set out in the AIA. Assessment of Change Notifications and Extensions for Quality Systems, MDR, IVDR. This step can sometimes lead to limited changes in scope about which you will be informed. chapter II) and Technical Documentation (Annex IX 4. The certification process is based on design activities (drawings, modeling, specifications), but consist mostly of engineering tasks (analysis, testing, assessment) where the applicant have to show, through certification documents, how Documents required for conducting the assessment procedure (e. / 2 4 20. The technical document must contain the following elements: Technical Documentation. Even if you subcontract the design or production of your Chapter II describes procedure for assessing the product’s technical documentation. EU Technical Documentation Assessment Certificate Regulation (EU) 2017/745, Annex IX Chapter II MDR 736239 R000 First Issue Date: 2022-11-09 Starting Validity Date: 2022-11-09 Current Issue Date: 2022-11-09 Expiry Date: 2027-11-08 Page 3 of 5 Aug 14, 2019 · ANNEX X. 10). g. The EU Declaration of Conformity is a part of the conformity assessment procedure in accordance with the EU product legislation. That information needs to be organised and presented in a way that demonstrates, if the device is approved; (a) it will conform to the EU’s technical requirements, (b) it will achieve its intended medical purpose and be safe to use Aug 12, 2022 · The post-market monitoring plan can be part of the technical documentation or the product’s plan. Click generate the certificate link above and fill in the details of your company/manufacturer, products, upload product pictures, and sign. van Vugt Managing Director Principal Certification Manager First Issued:17 June 2021 Date:24 June 2021 Expiry date: 1 June 2026 2 Scope. 4-a EU Type Examination May 7, 2020 · This certificate is issued to the manufacturers of the medical devices that comply with the conformity assessment specified in chapter II of Annex IX of MDR. . As mentioned in the first paragraph from Annex II of the MDR, ‘the technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the ANNE A: CHECKLIST OR MDR TECHNICAL DOCUMENTATION SUBMISSIONS 10 MDR Reference Requirements These columns to be completed by the manufacturers Completeness check by TÜV Rheinland Page / Section / Chapter of TD Referenced Evidence (Document Title & Number, applicable Chapter, Section etc. com. (l) Technical specifications as typically claimed in e. Application for lot inspection IVD. Box 5185, 6802 ED Arnhem, The Netherlands. The requirements for Technical Documentation review will vary based on the certificate type: • For devices assessed under a Product Specific annex, each device will be subject to a Technical Documentation review • For devices assessed under a Quality System-based annex, the Technical Documentation will be subject to Jan 24, 2024 · Conformity assessment. List of products – IVDD 98/79/EC. 2. 3) and an “EU technical documentation assessment certificate” (4. For context, read Art. Download and save or print the certificate immediately. 0 EU Technical Documentation Assessment Certificate This is to certify that the company RZ Medizintechnik GmbH Unter Hasslen 20 78532 Tuttlingen Germany SRN: DE-MF-000005616 has established and maintains the required Technical Documentation in s of. The conformity assessment usually involves an audit of the manufacturer's quality system and, depending on the type of device, a review of technical documentation from the manufacturer on the safety and performance of the device. 8 Option 1 Option 2 Class C QMS (Annex IX excl. C/2020/3213. Technical Documentation Assessment Service. is Notified Body with ID no 0344. The documentation must specify the applicable product safety requirements and cover the design, manufacture, and operation of the product. Apr 7, 2023 · The European Technical Assessment (ETA) provides an independent Europe-wide procedure for assessing the essential performance characteristics of non-standard construction products. 0 EU Technical Documentation Assessment Certificate This is to certify that the company Schülke & Mayr GmbH Robert-Koch-Straße 2 22851 Norderstedt Germany SRN: DE-MF-000005701 has established and maintains the required Technical Documentation The TGA has just released a new ruling revising an EU additional information requirement (specifically the EU technical documentation assessment certificate) required for Class IIa and Class IIb devices. e. Where the The European assessment document (EAD) is a harmonised technical specification for construction products. For the listing of information required for an ISO 13485:2016-compliant QMS, see this white paper: Checklist of May 27, 2020 · The technical file represents a set of documents that demonstrate the conformity of a product with the CE-marking legislation. This is to certify that the tested sample is in conformity with all provisions of Annex I of Council Directive 2004/108/EC. Annex X contains one half of the conformity assessment route typically chosen by manufacturers who choose not to fulfil the quality management system Medical Device Regulation, Annex IX Chapter II Section 4. Expiry date: 1 November 2027. Example*: * The example represents higher class devices and a best practice as understood based on To self-declare for the UKCA mark, you must keep documentation which demonstrates that your product conforms with the regulatory requirements set out in UK law. The EU Declaration of Conformity is a document, in which the manufacturer declares that the product conforms to the requirements. Annual surveillance audits are conducted by the Notified Body and unannounced audits can be decided by the Notified Body in-between surveillance audits. This reduces the overall time spent by the notified body and noncompliance findings raised due to the documents not being notified body considers there is a need for a supplement to the EU technical documentation assessment certificate or the initial EU type-examination certificate and hence a further consultation with the EMA. Change to any substance incorporated in or utilised for the manufacturing of a device and being subject to the specific procedures referred to in Sections 5 and 6 of Jan 14, 2023 · For the device: the EU technical documentation assessment certificate (under Annex IX) or EU type-examination certificate (under Annex X). You can find the conformity assessment procedures applicable to your medical device class set out in Annexes IX to XI of the MDR: Annex to EU Technical Documentation Assessment Certificate SRN of Manufacturer: DE-MF-000008106 Certificate ID: 170778746 De This annex is only valid in connection with the above-mentioned certificate. mdc medical device certification GmbH. 6, 70191 Stuttgart, Germany Notified body (identification number 0483) hereby certifies that the company (SRN: DE-MF-000005169) Serumwerk Bernburg AG. DoC and technical file) entirely on your own. the. DQS Medizinprodukte GmbH is a Notified Body according to Regulation (EU) 2017/745 of the Council concerning medical devices with the Identification Number 0297. IX. Conformity Assessment & Data Protection Impact Assessment (DPIA) For example, importers and US domestic manufacturers selling children’s products in the United States must issue a Children’s Product Certificate (CPC). Before placing in vitro diagnostic (IVD) devices on the market, most manufacturers will need their technical documentation assessed by a notified body. Surveillance Activities / PSUR / Changes 2 Submission and Technical Documentation contents. ) and an “EU technical documentation assessment certificate” (See 4. 10: "Changes to the approved device shall require approval from the notified body which issued the EU technical documentation assessment certificate where such changes could affect the safety and performance of the device or the conditions prescribed For products that are classified as Class II/III medical devices the Medical Device Regulation (MDR) requires an assessment of the technical documentation within the scope of the MDR conformity assessment procedure to place devices on the EU market. This procedure is called a conformity assessment and it is carried out during both the design and production phase. technical documentation) must be submitted in either German or English. 1 / 2. Certification The validity of this certificate can only be verified by the QR-code. What is the Low Voltage Directive 2014/35/EU? The Low Voltage Directive 2014/35/EU (LVD) is a European Directive that outlines safety requirements for all electrical equipment sold within the EU - specifically, 50-100V AC or 75-1500V DC. ) of the device and the accessories. Oct 5, 2023 · Technical report and documentation are at the License Holder’s disposal. The provider is responsible for creating the EU declaration of conformity and applying the CE marking of conformity. Checklist according to Annex I of Regulation (EU) 2017/746 (IVDR) List of In Vitro Diagnostic Medical Devices (IVDR) Structure of Technical Documentation for IVDR 2017/746 and IVDD 98/79/EC. 1. This certificate includes clear product identification (name If the application is successful, the Notified Body issues an “EU quality management system certificate” (See 2. As a manufacturer, you must carry out a risk analysis and ensure that your products comply with certain rules before placing them on the EU market. features, dimensions, performance attributes, etc. 4-4. T. It refers to the documents/records required by MDR annex II and III, so you won't have to do unnecessary work. EU Technical Documentation Assessment Certificate. Manufacturers play a crucial role in ensuring that products placed on the extended single market of the European Economic Area (EEA) are safe. 3. Annex to EU Technical Documentation Assessment Certificate SRN of Manufacturer: DE-MF-000005723 Certificate Aug 7, 2021 · 此時，NB 有兩個方法：1) 依據 Article 52 對此變更 再次進行符合性評鑑 ，或 2) 透過歐盟技術文件評鑑證書 附件 (Supplement to the EU technical documentation assessment certificate) 的方式處理。 此章第 5 節 (Specific additional procedures) 對於下列類型的產品有額外的規範： every device. English language can be accepted upon manufacturer explicit request. 2 / 2 vice ca tego r is and va iants co d by th s cer fica e: Device category: Polyurethane bandage Product name: Ligasano Models: n/a Mar 22, 2022 · EU-type Examination Certificates for Importers: A Practical Guide. CHAPTER I. Legal basis The legal basis for the assessment of the conformity of a device by a Notified Body, including the requirements of the applicable EU legislation, it will issue the appropriate certificate (as for example an EC or EU type-examination certificate, a design-examination certificate or a quality management system certificate). TUV NORD Polska Sp Commission Implementing Decision (EU) 2020/659 of 15 May 2020 on the harmonised standard for the technical documentation required for assessing materials, components and electrical and electronic equipment drafted in support of Directive 2011/65/EU of the European Parliament and of the Council. Note: When the Class D IVD device is for self-testing and near-patient testing, the Technical Documentation is also reviewed according to Section 5. competent authority designated by the Member Conformity, same SSCP/SSP, and/or same Technical Documentation as other devices assigned to the same Basic UDI-DI? All devices covered by a given Basic UDI-DI should be on the same product certificate, SSCP/SSP, and/or Technical Documentation. Annex X contains one half of the conformity assessment route typically chosen by manufacturers who choose not to fulfil the quality management system Before issuing an EU technical documentation assessment certificate, the notified body shall, having verified the usefulness of the substance as part of the device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States in accordance with Directive both certificates, the EU quality management system certificate (IVDR) as well as EU technical documentation assessment certificate (IVDR). Annual surveillance audits are conducted by the notified body and unannounced audits can be decided by the notified body in-between surveillance audits. Once the certification decision has been made, the EU To harmonise the compliance processes, the EU published the European Standard EN 50581:2012 “Technical documentation for the evaluation of electrical and electronic products with respect to restriction of hazardous substances” in 2013 (now referred to as EN IEC 63000:2018). This article describes how to comply with the Directive. This certificate does not imply an assessment of the production of the product and does not permit the use of a TUV Rheinland mark of conformity. The validity of the certificate will not exceed 5 years. 2 / 5 Device categories and variants covered by this certificate: Device category: Transparent, adhesive dressing 2 Submission and Technical Documentation contents. If the application is successful, the Notified Body issues an “EU quality management system certificate” (2. In Vitro Diagnostic Devices. Additionally, in the case of a third-party CA, the notified body must carry out periodic audits to make sure that the provider maintains and applies the quality management system. 23/6/2019 Ferry Vermeulen Law & Legislation. , an explanation of what is being requested and why) The Technical Documentation itself (i. Additional documents are also required Most manufacturers use harmonized standards to demonstrate the conformity of their devices with the general safety and performance requirements. It is developed by the European Organisation for Technical Assessment (EOTA) for cases where a product is not fully covered by harmonised European standards. Technical Documentation (Annex IX 4. Puławska 469, 02-844 Warszawa. Guidance on safety reporting in clinical investigations Appendix: Clinical investigation summary safety report form Aug 14, 2019 · ANNEX IX. A. 10: “Changes to the approved device shall require approval from the notified body which issued the EU technical documentation assessment certificate where such changes could affect the safety and performance of the device or the conditions prescribed for use of the device. Standards and harmonized standards a) Definitions and more EU Regulation 1025/2012 defines the term harmonized standard. 2. It is applicable for all classes of medical devices that require notified body intervention for their CE Marking process. Annex to EU Technical Documentation Assessment Certificate SRN of Manufacturer: DE-MF-000011641 Certificate ID: 170780710 This annex is only valid in connection with the above-mentioned certificate. Annex to EU Technical Documentation Assessment Certificate SRN of Manufacturer: DE-MF-000005768 Certificate An EU technical documentation assessment certificate; Manufacturers who do not fulfill the QMS requirements outlined in Annex IX can proceed to Annex X. MDCG 2020-10/2 Rev. 46 A CDx is intended for use with (a) corresponding medicinal product(s). LIFTING EQUIPMENT ENGINEERS ASSOCIATION. For more information on this topic, please see also the TÜV SÜD document on conformity assessment procedures for the different device types and classes. Upon review of current practices, the TGA identified that such a certificate is not issued for Class IIa or certain Class IIb medical devices The technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements listed in this Annex. Draw up an EU Declaration of Conformity and ensure that it accompanies the product. A lot of information will have been produced in the previous steps. Improved Efficiency: Implementing a QMS helps streamline processes, reduce errors Apr 26, 2024 · Regulatory Requirement Document Section MDR Annex I (General Safety and Performance Requirements), Annex IV (EU Declaration of Conformity), Art. Such product must be CE-marked followed by the 4-digits identification number (NB xxxx) of the notified body. Although the Regulation (EU) 2017/746 in In Vitro Diagnostic Medical Devices (IVDR) presents several challenges for manufacturers, the technical documentation requirements can seem daunting. The Notified Body will issue an EU type examination certificate after they have been provided with technical documentation, clinical evidence, and samples of the device for testing. 9 1 V e r s i o n 5. EU type-examination certificate (under Annex X) or EU product verification certificate (under Annex XI). The standard fees for the conformity assessment activities delivered by TÜV SÜD Product Service GmbH are as follows: Audit and QM System Assessment Services. 52 MDR, Section 2. The technical file must be available for inspection by the national market Feb 5, 2024 · EU technical documentation assessment certificate under Annex IX Chapter II ; EU quality management system certificate under Annex IX Chapter I ; EU quality assurance Certificate under Annex XI part A ; Surveillance auditing services; Assessing the Periodic Safety Update Report; Location: ul. Attention was given to the sampling size and depth of the assessment. Conformity assessment based on type – examination. The technical documentation can play a vital role in protecting a company, as it will retain information on how the product was developed and how it has ach. However, if this document or parts thereof Apr 25, 2023 · The manufacturer must provide the technical documentation, which should allow an assessment of the electrical equipment’s conformity to applicable requirements, and should include a risk analysis. This should be kept in the form of a technical file or document. 9 1 V e r s i o n 4. We hope you are safe and well as you read this update regarding BSI’s Technical Documentation (TD) assessment processes. Medicines Agency before issuing an EU technical documentation assessment certificate for the CDx. j B. The ETA offers manufacturers a voluntary route to CE marking, when the product is not or not fully covered by a harmonised standard (hEN) under the Construction Products Regulation (EU) 305/2011. Technical Documentation. catalogues, brochures (e. An arrangement is needed prior to commencing the certification process, for customers to submit the documents in another official language of the European Union. In the EU, a Declaration of Conformity is mandatory for products that require CE marking. V. Conformity assessment procedure: <enter reference to applicable Annex, for example for class I: Annex II and III> of the Regulation (EU) 2017/745. of the products)Specifications shall be consistent throughout the Technical Documentation, all labeling and clinical evaluat. Language Technical documentation and quality management system documentation shall be in Italian language. Holtus ¦ J. EU Technical Documentation Assessment Certificate Conformity Assessment Regulation 2017/745 on Medical devices, Annex IX Chapter II and III DEKRACertificationB. Hourly Rate*. CE marking based on Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation: December 2023: MDCG 2020-13 Word version: Clinical evaluation assessment report template: July 2020: MDCG 2020-10/1 Rev. This guideline has been prepared for NBs on how to assess the technical documentation on a representative basis according to the Directive 2007/47/EC. Where conformity has been established, the notified body shall issue an EU technical documentation assessment certificate. Quality management system. MDR technical documentation checklist. 320€. The technical documentation must also specify relevant requirements and cover the electrical equipment’s design, manufacture, and operation. Tissues or cells of animal origin or their derivatives ☐ Assessment of changes18 and update of the clinical evaluation ☐ Re-certification assessment ☐ Assessment of technical documentation for class IIa / IIb devices on a sampling basis Intended purpose: ☐ Check of clinical evaluation report authors CER dated and signed ☐ CVs provided for CER author(s) Comments: Confirm CVs are up to date Manufacturers can place a CE (Conformité Européenne) mark on a medical device once it has passed a conformity assessment. It is also an important core element in the process of medical device approval. , objective evidence to demonstrate compliance) Authorisation for BSI to carry out the work. Scope of DocumentThis best practice guidance document has been developed by members of Team NB who have reviewed the best practice guidance documents submitted by individual Team NB notified body members, with the purpose to develop a unified approach on the expectations of technical documentation submissi. 5. 4. Conformity assessment based on a quality management system and on assessment of technical documentation. Medical device technical documentation is a must-have for devices intended for the European Union. May 24, 2024 · Conformity Assessment. However, when it comes to some product categories – an assessment of technical documentation, the EU technical documentation assessment certificate (MDR annex IX chapter II) is issued. Meander 1051, 6825 MJ Arnhem P. com Website: www. Compile the set of technical documentation proving the machinery’s compliance with the requirements into a Technical File. Regardless of the class, technical documentation is mandatory for all medical devices. Audit. 1 MDCG 2020-10/2 Rev. Directive 2014/34/EU requires technical documentation to be established by the manufacturer. 3. 3 All Summary This SOP describes how a medical device is brought to the market while observing applicable regulatory requirements, including […] PROCESS CHART 2: TECHNICAL DOCUMENTATION ASSESSMENT FOR PARTICULAR CLASSES OF PRODUCT (ANNEX IX SECTION 4) Class III & IIb devices Recertification Periodic safety update report Y1, Y2, Y3 and Y4 Final assessment Issue certificate Certification cycle Corrective actions Technical documentation assessment Certification review Technical documentation Some less experienced Applicants for Type / Post-Type Certification in General Aviation, sometimes miss the practical experience with certification processes. Many products that require the CE mark can be ‘self-certified’ in the sense that you as an importer or manufacturer can arrange testing and prepare documentation (e. Under Article 16 (2) of the RoHS II Directive, a manufacturer who The notified body shall not deliver a supplement to the EU technical documentation assessment certificate if the scientific opinion is unfavourable and shall convey its final decision to the human tissues and cells competent authority concerned. dekra. This means that you are entitled to use CE 1639 on devices covered by your EU technical documentation assessment certificate, on completion of a successful assessment. jf uq tw kl jq cd bw qb cs qr