By Archana Nagajaran, Ph. 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. : V12 010283 0639 EU Chapter II describes procedure for assessing the product’s technical documentation. 02 Page 2 of 4 TÜV SÜD Product Service GmbH is Notified Body with identification no. Meander 1051, 6825 MJ Arnhem P. Annex IX, 4. 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. Language Technical documentation and quality management system documentation shall be in Italian language. T. By the way, this technical documentation review can occur either remotely as part of obtaining a CE certificate or during a routine QMS audit. 12: verification of each manufactured batch of Class D devices (Batch verification, incl. M. For products to receive CE marking, the manufacturer or importer must demonstrate that the. MEDICAL DEVICE REGULATION (EU) 2017/745 ANNEX IX OR XI PART A. Quality management system. 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. V75 113968 0006 Rev. T +31 88 96 83000 www. Certification. G70 019931 0018 Rev. 00 Page 2 of 3 TÜV SÜD Product Service GmbH is Notified Body with identification no. Regulation (EU) 2017/745 (MDR); Certification according to EN ISO 13485) ID: 57342 Doc No: MED_F_03. 3. cember 2019This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (. EU Technical Documentation Assessment Certificate This is to certify that the company 3M Deutschland GmbH trading as „Health Care Business“ Carl-Schurz-Str. 0 EU Technical Documentation Assessment Certificate This is to certify that the company EU Technical Documentation Assessment Certificate Conformity Assessment Regulation 2017/745 on Medical devices, Annex IX Chapter II and III DEKRACertificationB. 9). Annex to EU Technical Documentation Assessment Certificate SRN of Manufacturer: DE-MF-000005768 Certificate The European Technical Assessment (ETA)provides an independent Europe-wide procedure for assessing the essential performance characteristics of non-standard construction products. 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 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. testing at EU Reference Laboratory), including reporting of the decision to the manufacturer. In order to place the devices on the market with CE-marking, an EU Quality Management System Certificate pursuant to Annex IX chapter. A separate EU echnical documentation t assessment certificate will be issued upon successfully passing the assessment. g. I and III is necessary in addition to this EU Technical Documentation Assessment Certificate. For placing devices listed in the Annex on the market, an additional certificate according to Annex IX, Chapter I and III is required. the relevant directives and can be sold legally in the EU. 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 and applicability to the scope of the certification. Devices of class IIa and IIb listed in the Annex may bear the CE marking with the Technical documentation assessment report released; 3. is Notified Body with ID no 0344. 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 EU Technical Documentation Assessment Certificate (IVDR) Pursuant to Regulation (EU) 2017/746 on in Vitro Diagnostic Medical Devices, Annex IX, Chapter II, Section 4, 5. V. ) and an “EU technical documentation assessment certificate” (See 4. If the application is successful, the Notified Body issues an “EU quality management system certificate” (2. 0 EU Technical Documentation Assessment Certificate This is to certify that the company Miele & Cie. Certification Notice. e of the device, shall require approval from the notified body TÜV SÜD Product Service GmbH. . This initial audit comprises two stages, a “stage 1 audit” and a “stage 2 audit”. 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. The certificate consists of 2 pages. Holtus ¦ J. EU technical documentation assessment certificate(s) issued; 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 aintains and applies the quality system. Technical Documentation Assessment Service. Conformity assessment based on a quality management system and on assessment of technical documentation. Box 5185, 6802 ED Arnhem, The Netherlands. nl Company registration 09085396. 0123 the assessment of the technical documentation according to the Medical Devices Regulation (EU) 2017/745 Annex IX Chapter II, which are recorded in the report referred to in the annex. DQS Medizinprodukte GmbH is a Notified Body according to Regulation (EU) 2017/745 of the Council concerning medical devices with the Identification Number 0297. The document contains. Depending on the device classification, full or partial compliance with Annex IX is required. 10). May 8, 2024 · Where the AI system is in conformity with the requirements for high-risk AI systems, an EU technical documentation assessment certificate shall be issued by the notified body. KG KLS Martin Platz 1 78532 Tuttlingen Germany SRN: DE-MF-000005551 has established and maintains the required Technical Documentation in Aug 17, 2023 · For TD Assessment Certificates "[c]hanges 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" (Annex IX, 4. EADs are the basis for issuing European technical assessments. The validity of this certificate can only be verified by the QR-code. This supports an efficient and timely assessment of your submitted TD at TÜV SÜD premises. 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. 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 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. The certification phase commences when all technical documentations have been assessed with a positive result and all non-conformities are closed. Declaration of mutual recognition. In order to place the devices on the market with CE-marking, an EU Technical Documentation Assessment Certificate pursuant to Annex IX chapter II is necessary in addition to this EU Quality Management System Certificate. 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 The notified body shall provide the manufacturer with a report on the technical documentation assessment, including a clinical evaluation assessment report. ing may render this Certificate invalid:Changes in. Refer to Annex IX for assessments based on a quality management system and technical documentation; to Annex X for type examination assessments; and to Annex XI for product conformity testing assessments. The MDCG is composed of representatives of all Annex X: Conformity assessment based on type-examination. 00 Page 2 of 4 TÜV SÜD Product Service GmbH is Notified Body with identification no. 0123 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 Jun 2, 2020 · News: June 02 2020. 00 Page 2 of 2 TÜV SÜD Product Service GmbH is Notified Body with identification no. 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. KG Carl-Miele-Straße 29 33332 Gütersloh Germany SRN: DE-MF-000005768 has established and maintains the required Technical Documentation in 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 Mar 22, 2022 · EU-type Examination Certificates for Importers: A Practical Guide. According to Annex VII of the EU MDR, your Notified Body must: the technical documentation should be developed and handled. These can be found specifically in Annex II and Annex III of the regulation. 7. If the device conforms to the relevant provisions of this Regulation, the notified body shall issue an EU technical documentation assessment certificate. com. Hourly Rate*. Another exemption is related to Class IIb active administering devices that should pass clinical trials prior to being eligible for further assessment. 3. 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. 3) and an “EU technical documentation assessment certificate” (4. 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. For the class III devices covered this certificate is dependent on the continued validity of the EU Technical Documentation Asse. 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. All applicable requirements of the Testing, Certification, Guidance on sampling of devices for the assessment of the technical documentation: December 2019: MDCG 2019-12: Designating authority's final assessment form: Key information (EN) October 2019: MDCG 2019-10 rev. Conformity assessment. However, SGS may, based on documented evidence, decide to reduce the Regulation (EU) 2017/745 (MDR); Certification according to EN ISO 13485) ID: 57342 Doc No: MED_F_03. 0123 Annex IX (QMS and Technical Documentation) is used when a full Quality Management System (QMS) is implemented by the manufacturer. Identifying product requirements. documentation assessment. 10) with a similar formulation EU Technical Documentation Assessment Certificate. We hope you are safe and well as you read this update regarding BSI’s Technical Documentation (TD) assessment processes. D. Jul 11, 2019 · The assessment of the technical documentation shall apply for at least one representative device for each category of devices. Product: Nit-Occlud® Lê VSD EU Certificate no. 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. Class III custom-made implantable devices. Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation. It is applicable for all classes of medical devices that require notified body intervention for their CE Marking process. 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 Jun 17, 2022 · A follow-up consultation in case of changes affecting the performance and/or the intended use and/or the suitability of the device in relation to the medicinal product(s) concerned for which the notified body considers there is a need for a supplement to the EU technical documentation assessment certificate or the initial EU type-examination The summary forms are part of the technical documentation sent to the NB for assessment. Assessment of Change Notifications and Extensions for Quality Systems, MDR, IVDR. Aug 10, 2022 · Technical documentation Record keeping You, or your authorised representative (where allowed for in the relevant legislation), must keep documentation to demonstrate that your product conforms assessment of technical documentation, the EU technical documentation assessment certificate (MDR annex IX chapter II) is issued. However, when it comes to some product categories – an Technical Documentation Assessment Class D –Annex IX 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 new Regulation focuses on clinical performance, better traceability of medical devices and more transparency Product compliance. However, SGS may, based on documented evidence, decide to reduce the ASSESSMENT OF THE MDR TECHNICAL DOCUMENTATION WITHIN THE MDR CONFORMITY ASSESSMENT PROCEDURE . Tissues or cells of animal origin or their derivatives An EU technical documentation assessment certificate; Manufacturers who do not fulfill the QMS requirements outlined in Annex IX can proceed to Annex X. 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. For more information on this topic, please see also the TÜV SÜD document on conformity assessment procedures for the different device types and classes. dekra. van Vugt Managing Director Principal Certification Manager First Issued:17 June 2021 Date:24 June 2021 Expiry date: 1 June 2026 (EU) 2017/745 for the medical devices listed in the annex. Regulation (EU) 2017/745, which fulfils the following requirements: Annex IX - Chapter II (Assessment of the Technical Documentation) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. Technical documentation and EU declaration of conformity. 0123 Chapter II describes procedure for assessing the product’s technical documentation. 1. Devices of class IIa and IIb listed in the Annex may bear the CE marking with the (EU) 2017/745 are met including a valid Technical Documentation Assessment Certificate for Class III devices and implantable class IIb2 and class IIb active devices intended to administer and/or remove a 2 Except for sutures, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors, which 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. Any change to the AI system that could affect the compliance of the AI system with the EU AI Act’s requirements or its intended purpose shall be approved by the same 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. n suspicion, to pay unannounced visits. Class III and implantable Class IIb1 devices must additionally have an EU technical documentation assessment certificate before using CE 1639. 26 May 2026. 1: Application of transitional provisions concerning validity of certificates issued in accordance to the directives: October 2019 documentation assessment. > > Subcontractor Audit Expiry date: 1 November 2027. 21, 60433 Frankfurt am Main. Requirements regarding the technical documentation are covered in Annex 2 and Annex Before issuing an EU technical documentation assessment certificate, the notified body shall request an EU reference laboratory, where designated in accordance with Article 100, to verify the performance claimed by the manufacturer and the compliance of the device with the CS, where available, or with other solutions chosen by the manufacturer Aug 11, 2020 · EU MDR 101: Preparing Technical Documentation. 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. O. OVERVIEW OF THE CERTIFICATION PROCESS 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. TD assessment is a critical element of conformity assessments under both the Directives and Regulations. In addition, a review of Technical Documentation is necessary with or without the issuance of certificate. TUV NORD Polska Sp Regulation (EU) 2017/745, which fulfils the following requirements: Annex IX - Chapter II (Assessment of the Technical Documentation) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. The Certification Notice also identifies the necessary information related to DQS Medizinprodukte GmbH is a Notified Body according to Regulation (EU) 2017/745 of the Council concerning medical devices with the Identification Number 0297. / 2 4 20. OVERVIEW OF THE CERTIFICATION PROCESS The certification cycle is usually based on five years. 31 December 2028. Even if you subcontract the design or production of your 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. , an explanation of what is being requested and why) The Technical Documentation itself (i. Legal basis The legal basis for the assessment of the conformity of a device by a Notified Body, including the LIFTING EQUIPMENT ENGINEERS ASSOCIATION. 320€. A. 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. This document outlines each stage of the assessment process for the above regulation and gives essential guidance to organizations seeking certification. 2. CHAPTER I. Notified Body reserves the right, on a spot basis or based. Limitations to this certificate are listed in the Annex. 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. j B. English language can be accepted upon manufacturer explicit request. It gives a clear and structured oversight regarding the medical device description for 3rd parties. The medicinal authority consulted shall provide its opinion to the NB within ___ days of receipt of all necessary The Technical Documentation is a comprehensive description of your device intended to demonstrate compliance with European regulatory requirements. Regardless of the class, technical documentation is mandatory for all medical devices. Annex IX every device. 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. / 5 4 20. G70 037258 0025 Rev. 5. It is independent/separate The validity of this certificate can only be verified by the QR-code. 1 41453 Neuss Germany SRN: DE-MF-000011641 has established and maintains the required Technical Documentation in accordance with Annex IX, Chapter II of the Regulation (EU) 2017/745 The validity of this certificate can only be verified by the QR-code. Devices covered by valid MDD/AIMDD Certificates (as of 2023/03/20 and that are Class III, or Class IIb implantable devices excluding well-established technologies (WET)* under MDR. Aug 14, 2019 · ANNEX IX. Certification Your certification process explained. : 51133-61-A0 Certificate valid from: 2023-09-06 Certificate valid to: 2028-09-05 Karin Leicht 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. Manufacturers of class I devices, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 19 after drawing The European assessment document (EAD) is a harmonised technical specification for construction products. Once this phase is completed, the assessment of technical documentation starts followed by an initial audit. 4. 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. 1 The validity of this certificate can only be verified by the QR-code. 2. leeaint. Upon review of current practices, the TGA identified that such a certificate is not issued for Class IIa or certain Class IIb medical devices Transition timelines. The CE mark, which is an acronym for Conformité Européenne (European Conformity), indicates that a product meets the requirements of. File Type: pdf 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 In order to place the devices on the market with CE-marking, an EU Quality Management System Certificate pursuant to Annex IX chapters I and III is necessary in addition to this EU Technical Documentation Assessment Certificate. 9 1 V e r s i o n 4. 1. Tissues or cells of animal origin or their derivatives This means you are entitled to use CE 1639 on devices within your scope, on the completion of a successful audit and technical documentation assessment. Devices. You must read and understand it to minimize nonconformities and delays in certification both certificates, the EU quality management system certificate (IVDR) as well as EU technical documentation assessment certificate (IVDR). IX. 31 December 2027. The validity of this certificate can only Service GmbH. Accredited Body: DQS Medizinprodukte GmbH, August-Schanz-Str. If the application is successful, the Notified Body issues an “EU quality management system certificate” (See 2. Three things are required for any Technical Documentation review: Context (i. The Technical Documentation is subject to regular surveillance. 4 months ago 4 months ago. This certificate is based on the assessments listed in CNo51133-00 and is only valid in conjunction with the successful completion of the annual surveillance audits. However, if this document or parts thereof 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. 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 facturer or importer to meet the applicable EU directives. ANNEX X It refers to the documents/records required by MDR annex II and III, so you won't have to do unnecessary work. Jan 11, 2024 · Its helpful to understand what your Notified Body must do as part of the technical documentation review. “The Basic UDI-DI is the main access key in the database and relevant documentation (e. e. U) 2017/745. The validity of the certificate will not exceed 5 years. This procedure is called a conformity assessment and it is carried out during both the design and production phase. DEKRA Certification B. Surveillance Activities / PSUR / Changes The validity of this certificate can only be verified by the QR-code. Additionally, MDR guidelines published by the European Commission (EC) have raised Mar 11, 2024 · Bicon, LLC – EU Technical Documentation Assessment Certificate; EU Technical Documentation Assessment Certificate. For class IIb implantable devices exempted according to 52,4, the Article technical documentation must be also assessed for every device, but no additional Oct 31, 2023 · Different types of conformity assessment procedures exist, and the one you need to follow depends on your medical device’s classification. 9 1 V e r s i o n 5. 210 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. DoC and technical file) entirely on your own. Certificate History Identification of the Common Specifications and Harmonized Standards complied with are documented within the technical documentation and audit assessments carried out. All applicable requirements of the Testing, Certification, Jan 24, 2024 · Conformity assessment. com Website: www. In case a technical documentation assessment certificate or a type examination certificate has been previously issued, DEKRA expects the client to lodge a formal Renewal Application in a timely manner; at least 6 months prior to expiry of the certificate(s). 1 / 2. 2 Submission and Technical Documentation contents. 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 The standard fees for the conformity assessment activities delivered by TÜV SÜD Product Service GmbH are as follows: Audit and QM System Assessment Services. Puławska 469, 02-844 Warszawa. EU Certificate no. G70 010275 0546 Rev. 0 EU Technical Documentation Assessment Certificate This is to certify that the company KLS Martin SE & Co. Integral publication of this certificate and adjoining reports is allowed. All applicable requir. 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. It is developed by the European Organisation for Technical Assessment (EOTA) for cases where a product is not fully covered by harmonised European standards. Additionally, MDR guidelines published by the European Commission (EC) have raised 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. 2 (Class C Devices, Companion Diagnostics) No. Feb 23, 2023 · The Technical Documentation is subject to regular surveillance. Audit. 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. Ecodesign requirements. These are traceable through the DEKRACertification B. , objective evidence to demonstrate compliance) Authorisation for BSI to carry out the work. : 51133-60-02-00 Certificate valid from: 2023-12-15 Certificate valid to: 2025-11-08 Regulation (EU) 2017/745, which fulfils the following requirements: Annex IX - Chapter II (Assessment of the Technical Documentation) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. Periodical audits not MDCG 2019-13. However, the Medical Device Regulation (MDR) EU 2017/745 and In Vitro Diagnostic Regulation (IVDR Chapter II describes procedure for assessing the product’s technical documentation. The certificate consists of 3 pages. fc pn gq cl jm dn ip my ip vd