The European Union Medical Device Regulation of 2017. However, it is not identical to the GHTF STED as there are a number of additional sections in the new EU MDR Annex II which reflect the specific focus of the European authorities on certain topics; information on medicinal substances, on tissues or cells of human or animal origin, on substances intended to be introduced into the human body. In the opinion of the author, the Technical Documentation is one topic which can and should be addressed by Manufacturers without delay. Regulation (EU) 2017/745. Under the EU MDR, Notified Bodies issue an EU quality management system certificate according to Annex IX of Regulation (EU) 2017/745. If you would like to request MDR services from TÜV SÜD, please use this form to register your interest.. Based on the product classification, the manufacturer must apply for an applicable conformity assessment procedure. 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. (EU MDR 2017/745 ANNEX II TECHNICAL DOCUMENTATION: The technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer shall be presented in a clear, organized, readily searchable and unambiguous manner and shall include the elements listed in this Annex.) Unfortunately, this question has to be answered with a “no”. MDR Application Procedure. Therefore, medical device manufacturers shall use this annex to ensure compliance with the new regulation. Thank you for your question. 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. Mar 8, 2019 #14. This guidance provides information on the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR). Last edited by a moderator: Mar 7, 2019. dgrainger. 1223/2009 und zur Aufhebung der Richtlinien 90/385/EWG und 93/42/EWG des Rates 6. MassimoP Z - Annex (2) II - Technical documentation annex, ANNEX II, mdr, technical documentation ANNEX II (PART 1) Technical documentation. Regulation (EU) 2017/745. ANNEX II, Last update: 24/11/2020 LIST OF SUBSTANCES PROHIBITED IN COSMETIC PRODUCTS Reference number Substance identification Chemical name / INN CAS Number EC Number Update Date 1 N-(5-Chlorobenzoxazol-2-yl)acetamide 35783-57-4 - 17/10/2010 2 (2-Acetoxyethyl)trimethylammonium hydroxide (Acetylcholine) and its salts 51-84-3 200-128-9 17/10/2010 3 Deanol aceglumate (INN) 3342 … The (primary) Technical Documentation of Annex II of new EU MDR is clearly based on the so called summary technical documentation or STED, developed by the former Global Harmonisation Task Force (GHTF). VERORDNUNG (EU) 2017/745 DES EUROPÄISCHEN PARLAMENTS UND DES RATES. TÜV SÜD has developed an online service registration form to allow us to systematically process your request. Requirements regarding design and construction II. The devices must be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in Section I on the 'General requirements'. We offer an easy and low-cost software solution to manage UDI and communicate with EUDAMED. The documentation shall contain the results and critical analyses of all verifications and validation tests and/or studies undertaken to demonstrate conformity of the device with the requirements of this Regulation and in particular the applicable general safety and performance requirements. The MDR does provide guidelines as to which content must be present in a technical documentation for approval in the European area, however, it does not give explicit information in terms of the structureand uniformity of the documents. EU Medical Device Regulation (MDR 2017/745) Annex II In addition to the specific requirements identified within Annex I of the EU MDR, Annex II – Technical Documentation identifies additional requirements. The Commission shall immediately transmit those documents to the relevant expert panel referred to in Article 106. So Manufacturers are advised to immediately start mapping the Technical Documentation of the new EU MDR to their available documentation and to start work on filling any gaps. MassimoP Z - Annex (2) II - Technical documentation annex, ANNEX II, mdr, technical documentation ANNEX II (PART 1) Technical documentation. The notified body shall transmit its clinical evaluation assessment report, along with the manufacturer’s clinical evaluation documentation, referred to in points (c) and (d) of Section 6.1 of Annex II, to the Commission. Finally, it is important to document the decision on the classification and the supporting justification. However, it is likely that these certificates will also have a limited period of validity. (2) A relevant device which is a device for self-testing but which is not referred to in a list in Annex II may bear a CE marking only if its manufacturer or his authorised representative— (a) fulfils the applicable obligations imposed by— (i) Sections 1 to 6 of Annex III, (ii) Annex IV, or (iii) Annex V and either Annex VI or Annex … Annex II Technical File Documentation. CHAPTER II. Mar 8, 2019 #14. Click here for the latest consolidated text . Common specifi… Accessories for a medical device and for a product listed in Annex XVI shall be classified in their own right separately from the device with which they are used. (61) The conformity assessment procedures for devices should be further strengthened and streamlined whilst the requirements for notified bodies as regards the performance of their assessments should be clearly specified to ensure a level playing field. If you need help with MDR transition strategy, gap assessments, or simply getting up to speed quickly on the MDR requirements, check out our MDR training and consulting options. Don't forget that you need to also check the machinery directive as per Article 1.12: 12. That’s not to underestimate the amount of work that will be required to switch from the current MDD to the new EU MDR. TÜV SÜD has developed an online service registration form to allow us to systematically process your request. Trusted Information Resource. This is not an exhaustive list and whilst BSI believes that it accurately reflects the regulatory environment at the time of publication, you should be aware that this is complex and can change. GSPR is replacing the Essential Requirements that were on the MDD Annex I. 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