Aug 11, 2020 · EU MDR 101: Preparing Technical Documentation. 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. Labelling information and a copy of the instructions for use (IFU). These can be found specifically in Annex II and Annex III of the regulation. 0 EU Technical Documentation Assessment Certificate This is to certify that the company Miele & Cie. D. Design and manufacturing information. testing at EU Reference Laboratory), including reporting of the decision to the manufacturer. Certification. Aug 14, 2019 · Conformity assessment based on type – examination 1. Technical Documentation Assessment Service. This supports an efficient and timely assessment of your submitted TD at TÜV SÜD premises. 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. Medicines Agency before issuing an EU technical documentation assessment certificate for the CDx. Kriegerstr. Application The manufacturer shall TÜV Rheinland and medical device manufacturers are keen to streamline and speed up the assessment of the Techni-cal Documentation as part of initial applications, during surveillance activities, substantial change notifications, renewal applications etc. Class C for self-testing or near-patient testing. The Member State in which the notified body is established may require that all or certain documents, including the technical documentation, audit, assessment and inspection reports, relating to the procedures referred to in paragraphs 1 to 7 and 9 to 11 be made available in an official Union language(s) determined by that Member State. The document contains. / 3 4 20. Manufacturers of approved medical devices must also regularly update the clinical evaluation report in a pre-defined Modus to include data from actual post-approval experience of the device such as Post Market 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. certificates, declaration of conformity, technical documentation and summary of safety and clinical performance) to connect devices with same intended purpose, risk class and essential design and manufacturing characteristics. MDR technical documentation checklist. 120 Rue Marc Lefrancq | BP 20392 | FR-59307 Valenciennes Cedex 1 / 72 Tel. IEC 63000 Review & Gap Assessment. EADs are the basis for issuing European technical assessments. KG Carl-Miele-Straße 29 33332 Gütersloh Germany SRN: DE-MF-000005768 has established and maintains the required Technical Documentation in Technical documentation will usually include: • Risk assessments (ISO 12100) • Technical description. 3. 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. The new Regulation focuses on clinical performance, better traceability of medical devices and more transparency the ‘Summary Technical Documentation (STED)’, intended to be a consistent, summarized or abridged form of the technical documentation, with sufficient detail to allow the NB to fulfil its obligations. The incorporation of AI in medical devices has made great strides, for example, in the diagnosis of disease. Additionally, MDR guidelines published by the European Commission (EC) have raised MDCG 2019-13. 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 management system assessment has to be accompanied by assessment of the technical documentation for devices selected on a representative basis. Once approved, your certificates will be issued electronically to your organization. The MDCG is composed of representatives of all 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. Bill of Material Conformity Assessment. The MDCG is composed of representatives of all The validity of this certificate can only be verified by the QR-code. both certificates, the EU quality management system certificate (IVDR) as well as EU technical documentation assessment certificate (IVDR). You can find the conformity assessment procedures applicable to your medical device class set out in Annexes IX to XI of the MDR: Generated by CLaiRK, edited by us. 320€. 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. Even if you subcontract the design or production of your Technical documentation assessment report released; 3. 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. 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. Medical device and IVD manufacturers are accustomed to doing mock audits for quality systems and ISO certification, but these types of assessments are a relatively new concept in the regulatory realm. Assessment of Change Notifications and Extensions for Quality Systems, MDR, IVDR. Technical document Dec 13, 2019 · For example, Class IIb implantable medical devices are exempt from sampling while it is required to obtain an EU technical documentation assessment certificate for such devices. Conformity assessment procedure: <enter reference to applicable Annex, for example for class I: Annex II and III> of the Regulation (EU) 2017/745. The certificate of conformity issued by the Notified Bodies is valid for a maximum of 5 years. All applicable requirements of the testing and certification regulation of TÜV SÜD Group have to be complied with. Your certification process explained. TUV NORD Polska Sp Jan 24, 2024 · Conformity assessment. Example*: * The example represents higher class devices and a best practice as understood based on Mar 13, 2022 · The European Medical Device Regulation (EU) 2017/745 (MDR) requires medical device manufacturers to provide thorough and complete technical documentation for any product sold in Europe. 52 MDR, Section 2. Declaration of mutual recognition. Legal basis The legal basis for the assessment of the conformity of a device by a Notified Body, including the In any case, Technical Documentation for the medical devices needs to be drawn up and kept up to date by the manufacturers. 1 of 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： Mar 12, 2020 · The EU Declaration of Conformity (DoC) is a legal document, wherein a manufacturer formally declares the compliance of a product with the essential health, safety and environmental requirements of the relevant directives. The applicant is responsible for all of the fees and costs associated with any activity that SGS 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. 36 Revision: 5 - released Effective: 29 Nov 2019 Page 2 of 5 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. Competent Authority or EMA consultation (Annex IX, Section 5. mdc medical device certification GmbH. • Bill of materials. For more information on this topic, please see also the TÜV SÜD document on conformity assessment procedures for the different device types and classes. / 2 4 20. A separate EU echnical documentation t assessment certificate will be issued upon successfully passing the assessment. Please take a look at ANNEX XII CERTIFICATES ISSUED BY A NOTIFIED BODY to see the type and contents of the certificates issued by NBs: "EU technical documentation assessment certificates" AND "EU quality management system certificates" Medicinal substance Devices Before issuing an EU technical documentation assessment certificate, the NB seeks scientific opinion from one of CA in accordance with directive 2001/83/ec or EMA, depending which has been consulted. It refers to the documents/records required by MDR annex II and III, so you won't have to do unnecessary work. The technical documentation should also include details of testing and conformity assessment procedures carried out by the manufacturer or importer. Limitations to this certificate are listed in the Annex. The medicinal authority consulted shall provide its opinion to the NB within ___ days of receipt of all necessary (MDCG) established by Article 103 of Regulation (EU) 2017/745. It will also be useful for Designating Authorities in monitoring the performance of their NBs in this area. Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation. To bring medical devices into the EU market, depending on the classification and chosen MDR Jun 19, 2019 · Definitely yes. • Details of any design calculations. By Archana Nagajaran, Ph. chapter II) and Technical Documentation (Annex IX 4. IX. It is one of the most complicated technical files, as many technical documents may be required. competent authority designated by the Member Feb 23, 2023 · The validity of this certificate can only be verified by the QR-code. This document outlines each stage of the assessment process for the above regulation and gives essential guidance to organizations seeking certification. Additionally, MDR guidelines published by the European Commission (EC) have raised 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 The clinical evaluation report must include all clinical evidence required to support medical device conformity assessments in the EU. leeaint. OR. Annex to EU Technical Documentation Assessment Certificate SRN of Manufacturer: DE-MF-000005768 Certificate 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). As such, technical documentation is mandatory for electronics, toys, protective equipment, medical devices, machinery, and more. February 13, 2023. j B. 1 / 2. The CE marking process also requires the manufacturer or importer to undergo a conformity assessment procedure, which involves testing the product‘s design, features, and performance, to Oct 31, 2023 · For Class IIa and IIb devices, the surveillance assessment also includes an evaluation of the technical documentation. Note: As a Notified Body, BSI cannot offer consultancy advice, only auditing services. Annex XI (Production Quality Assurance) is used in association with Annex X or in combination with Technical Documentation (Annexes II and III) for low-risk devices. Dec 22, 2021 · Notified bodies will issue CE Certificates, MDR Technical Documentation Assessment Certificates, or Type Examination Certificates, depending on the device’s class. 0123 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 Mar 16, 2022 · The European Medical Device Regulation (EU) 2017/745 (MDR) requires medical device manufacturers to provide thorough and complete technical documentation for any product sold in Europe. • Specification and, where applicable, Declarations of Conformity for the critical components and materials used. 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 provisions of this Regulation. With the rollout of EU MDR and IVDR, manufacturers are facing new challenges, especially when it comes to technical documentation review. Technical Documentation Assessment Sample per device category As per the Technical Documentation Sampling Plan. Technical Documentation Assessment Class B/C/D for Self-Testing – Annex IX Technical Documentation Assessment Class B/C/D for Near-Patient Testing – Annex IX Technical Documentation Assessment Class C/D for Companion Diagnostics – Annex IX EU QM Certificate No. The European Commission published a list of recognized notified bodies that perform assessment tests on products like toys, electronics, medical devices, and more. If the device conforms to the relevant provisions of this Regulation, the notified body shall issue an EU technical documentation assessment certificate. 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 Technical Documentation Sample per Assessment category of devices As per the Technical Documentation Sampling Plan Clinical Evaluation Consultation Procedure (Article 54) N/A N/A N/A N/A N/A N/A Consultations (Rule 14, Rule 18, Rule 21) N/A N/A N/A N/A N/A N/A Summary of Safety and Clinical Performance (Article 32) N/A N/A N/A N/A N/A N/A Jul 11, 2019 · 12. 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 Regulation (EU) 2017/745 (MDR); Certification according to EN ISO 13485) ID: 57342 Doc No: MED_F_03. Such product must be CE-marked followed by the 4-digits identification number (NB xxxx) of the notified body. 3. 2. However, a change in sterilization method should trigger a report to NB under 4. Certification The notified body shall assess the planned changes and decide whether the planned changes require a new conformity assessment in accordance with Article 52 or whether they could be addressed by means of a supplement to the EU technical documentation assessment certificate. Compiling your technical documentation is a critical step in Europe's CE Marking process and a requirement for compliance with the Medical Devices Regulation (EU MDR 2017/745) and the In-Vitro Annex X: Conformity assessment based on type-examination. On 26 May 2017, a new regulation entered into force, meaning that by 26 May 2020, for manufacturers to obtain or renew a CE certificate or to issue a Declaration of Conformity (DoC), their technical documentation will need to comply with the Medical Device Regulation (MDR) European Union (EU) Regulation 2017/745 (referred to as ‘MDR’ hereafter). Language Technical documentation and quality management system documentation shall be in Italian language. At a minimum, a technical file for medical devices should contain: A device description and specification section, including the UDI number. cember 2019This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (. Issue the EU-type examination certificate. 8 Option 1 Option 2 Class C QMS (Annex IX excl. Regardless of the class, technical documentation is mandatory for all medical devices. It is independent/separate from the In May 2017 the new Regulation on Medical Devices (MDR) came into force in order to replace the current Medical Device Directive (93/42/EEC) (MDD) & Active Implantable Medical Devices Directive (90/385/EEC) (AIMDD) as of 26 May 2021. Surveillance Activities / PSUR / Changes Technical document MNB – ERA Assessment Scheme 000MRA1044 ver 2. You must read and understand it to minimize nonconformities and delays in certification Technical Documentation (Annex IX 4. : V12 010283 0639 EU Technical Documentation Assessment Certificate No. Hourly Rate*. 6, 70191 Stuttgart, Germany Notified body (identification number 0483) hereby certifies that the company (SRN: DE-MF-000005169) Serumwerk Bernburg AG. 2) N/A N/A N/A N/A N/A N/A 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. A. The Technical Documentation is a comprehensive description of your device intended to demonstrate compliance with European regulatory requirements. 02 Page 2 of 4 TÜV SÜD Product Service GmbH is Notified Body with identification no. May 24, 2024 · Conformity Assessment. 2(a) of Annex VII requires the Notified Body to draw up and keep up to date, a sampling plan for the assessment of Technical Documentation as referred to in Annexes II and III prior to 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. It is also an important core element in the process of medical device approval. In the latter case, the notified body shall assess the changes, notify Technical File Services Workflow: Intertek provides the following services to help companies achieve compliance with RoHS and IEC 63000: Education & Training. The validity of the certificate will not exceed 5 years. CE marking based on 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. After the assessment, the Notified body will issue the EU technical documentation assessment certificate. The European Technical Assessment (ETA)provides an independent Europe-wide procedure for assessing the essential performance characteristics of non-standard construction products. The Commission assigns a 4-digit code to each Notified Body, with the purpose of uniquely identifying each company that acts as a Jul 8, 2024 · The assessment of the technical design of the EU fertilizer product is carried out on the basis of an examination of the technical documentation (type examination -Module B) by a notified body. U) 2017/745. The notified body shall provide the manufacturer with a report on the technical documentation assessment, including a clinical evaluation assessment report. This certificate can be extended upon the manufacturer’s application, accompanied by a reassessment. The surveillance assessment shall also include an assessment of the technical documentation for the device or devices concerned on the basis of further representative samples. 2 Scope. 0 Moving Europe towards a sustainable and safe railway system without frontiers. Another exemption is related to Class IIb active administering devices that should pass clinical trials prior to being eligible for further assessment. eu Any printed copy is uncontrolled. ) or in case of NA include justification Check off 3. 5. Holtus ¦ J. Ecodesign requirements. During the subsequent internal production control (module C), the manufacturer declares on his own responsibility that the fertilizer product complies The validity of this certificate can only be verified by the QR-code. Technical Documentation. EU Technical Documentation Assessment Certificate Conformity Assessment Regulation 2017/745 on Medical devices, Annex IX Chapter II and III DEKRACertificationB. van Vugt Managing Director Principal Certification Manager First Issued:17 June 2021 Date:24 June 2021 Expiry date: 1 June 2026 The NB examines and/or tests the representative sample and associated Technical Documentation to determine whether the device meets IVDR requirements and especially the GSPR. EU Technical Documentation Assessment Certificate. Material and Supplier Risk Assessment. The Technical Documentation is subject to regular surveillance. g. EU Technical Documentation Assessment Certificate (MDR) Pursuant to Regulation (EU) 2017/745 on Medical Devices, Annex IX Chapter II (Implantable Class IIb Devices and Class III Devices) No. com Website: www. Following the completion of the technical documentation assessment, a certification decision is made, including final approval of the summary of safety and clinical performance. It is developed by the European Organisation for Technical Assessment (EOTA) for cases where a product is not fully covered by harmonised European standards. By drawing up and then signing the EU Declaration of Conformity, the manufacturer assumes full responsibility for the 4. The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. 9. 10. By following this document, you help to perform an efficient and timely assessment of the Technical Documentation. This document aims to familiarize stakeholders with the requirements outlined in Annex II to the Medical Device Regulation. Mandatory. 1. The MDCG is composed of representatives of all Member States and a representative of the European Commission chairs it. The technical documentation shall be drawn up in such a way as to demonstrate that the high-risk AI system complies with the requirements set The standard fees for the conformity assessment activities delivered by TÜV SÜD Product Service GmbH are as follows: Audit and QM System Assessment Services. Manufacturers of devices with machine learning face the challenge of having to demonstrate compliance of their devices with the regulations. 4-4. The technical documentation of a high-risk AI system shall be drawn up before that system is placed on the market or put into service and shall be kept up-to date. 9 1 V e r s i o n 5. Section 4. ANNEX X Product compliance. It provides information on the elements that need to be included in the Technical Documentation ☐ 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 The Basic UDI-DI is the main key in the database and relevant documentation (e. Manufacturers can look up a list of Notified Bodies on the European Commission’s website. A Technical Documentation surveillance audit is required every year whilst there are still devices left to be reviewed under the certificate scope. The European assessment document (EAD) is a harmonised technical specification for construction products. Depending on the type of 47 medicinal product concerned, the notified body shall consult the European Medicines Agency or a 48. 12: verification of each manufactured batch of Class D devices (Batch verification, incl. Once the certification decision has been made, the EU 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. However, if this document or parts thereof Dec 14, 2020 · f. 9 1 V e r s i o n 4. 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 CERTIFICATION REVIEW. If this document or parts thereof is not followed, it will still be possible to conduct a successful assessment of the Technical Documentation, however, the time needed, and hence the costs associated, could increase. Identifying product requirements. Nov 23, 2022 · During the assessment of Technical Documentation as per Annex II & Annex III, the notified body shall also conduct required test in relation to the device or may ask the manufacturer to carry those tests. The conformity of the Technical Documentation has been verified and confirmed in Conformity Assessment Procedures according to Article 52. Technical documentation contains detailed information about the medical device, its intended use, specifications, design Regulation (EU) 2017/745 are met including a valid Technical Documentation Assessment certificate for Class III, implantable class IIb2 and class IIb active devices intended to administer and/or remove a medicinal product. Aug 14, 2019 · 4. 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 Regulatory requirements for medical devices with machine learning. 0 EU Technical Documentation Assessment Certificate This is to certify that the company Ondal Medical Systems GmbH Wellastraße 6 36088 Hünfeld Germany SRN: DE-MF-000000203 has established and maintains the required Technical Documentation in Service GmbH. Attention was given to the sampling size and depth of the assessment. Annex X AND Annex XI (except section 5). com. 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. 2. Conformity assessment. Audit. and reducing time to certification. You will get 2 separate procedures. This step can sometimes lead to limited changes in scope about which you will be informed. Manufacturer applies to BSI Application and contract review Final Certification Review Certification Decision Certificate Issued Proposal QMS Assessment Technical Documentation Aug 14, 2019 · (a) EU technical documentation assessment certificates, EU type-examination certificates and EU product verification certificates shall include a clear identification, including the name, model and type, of the device or devices, the intended purpose, as included by the manufacturer in the instructions for use and in relation to which the device has been assessed in the conformity assessment 4. Technical documentation assessment report released; 3. For class IIb implantable devices exempted according to 52,4, the Article technical documentation must be also assessed for every device, but no additional CE Marking. Upon review of current practices, the TGA identified that such a certificate is not issued for Class IIa or certain Class IIb medical devices . 46 A CDx is intended for use with (a) corresponding medicinal product(s). 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. V. Supply Chain Data Collection. This procedure is called a conformity assessment and it is carried out during both the design and production phase. It is applicable for all classes of medical devices that require notified body intervention for their CE Marking process. The NB decides whether the planned changes require a new conformity assessment or a supplement to the EU technical documentation assessment certificate. every device. europa. It gives a clear and structured oversight regarding the medical device description for 3rd parties. MEDICAL DEVICE REGULATION (EU) 2017/745 ANNEX IX OR XI PART A. For context, read Art. +33 (0)327 09 65 00 | era. The validity of this certificate can only be verified by the QR-code. Surveillance Activities / PSUR / Changes EU Technical Documentation Assessment Certificate. Technical File Creation Support. Technical documentation and EU declaration of conformity. The CE mark is a mark that must be affixed on certain types of products by the manufacturer itself, which with it self-certifies compliance (or conformity) to the essential requirements for marketing and use in the European Union set out in the New Approach directives. The STED represents the status of the medical device at a specific moment of its life cycle and should be updated to correspond to the technical 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. M. However, understanding what to include in your technical documentation, and Jan 14, 2023 · Annex IX, chapters I and III AND Technical documentation assessment (of at least 1 representative device per generic group), per section 4 of Annex IX. Annex IX, 4. G70 037258 0025 Rev. Annex IX, chapters I and III AND Technical documentation assessment, per sections 4 and 5. Requirements regarding the technical documentation are covered in Annex 2 and Annex LIFTING EQUIPMENT ENGINEERS ASSOCIATION. 4-a EU Type Examination MDCG 2019-13. EU technical documentation assessment certificate(s) issued; 4. Puławska 469, 02-844 Warszawa. Medical device technical documentation is a must-have for devices intended for the European Union. 2 / 5 Device categories and variants covered by this certificate: Device category: Transparent, adhesive dressing assessment of technical documentation, the EU technical documentation assessment certificate (MDR annex IX chapter II) is issued. Your Notified Body shall, according to Annex VII of the EU MDR: both certificates, the EU quality management system certificate (IVDR) as well as EU technical documentation assessment certificate (IVDR). 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. Oct 29, 2018 · The section describes how to set up the sampling plans, not the content of the EU certificate. T. Nov 16, 2023 · Technical documentation, also referred to as a technical file, is mandatory for most products that require CE marking in the European Union. • Drawings, circuit diagrams, and photos. Although medical device manufacturers have more time to prepare due to the delayed EU MDR deadline, this shouldn’t distract from the extensive documentation they must compile in the meantime to prove their devices are compliant.
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