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# Regulation Tracker Subject Status
3258 MDR Database MDRQ ANNEX XVII CORRELATION TABLE Released Actions
3259 MDR Database MDRQ Council Directive 90/385/EEC Council Directive 93/42/EEC This Regulation Article 1(1) Article 1(1) Article 1(1) Article 1(2) Article 1(2) Article 2 Article 1(3) Article 1(3) first subparagraph Article 1(9) first subparagraph ' Article 1(3) second subparagraph Article 1(9) second subparagraph Article 1(4) and (4a) Article 1(4) and (4a) Article 1(8) first subparagraph Article 1(5) Article 1(7) Article 1(11) Article 1(6) Article 1(5) Article 1(6) ' Article 1(6) ' ' Article 1(8) Article 1(13) Article 2 Article 2 Article 5(1) Article 3 first paragraph Article 3 first paragraph Article 5(2) Article 3 second paragraph Article 3 second paragraph Article 1(12) Article 4(1) Article 4(1) Article 24 Article 4(2) Article 4(2) Article 21(1) and (2) Article 4(3) Article 4(3) Article 21(3) Article 4(4) Article 4(4) Article 10(11) Article 4(5)(a) Article 4(5) first subparagraph Article 20(6) Article 4(5)(b) Article 4(5) second subparagraph ' Article 5(1) Article 5(1) Article 8(1) Article 5(2) Article 5(2) Article 8(2) Article 6(1) Articles 5(3) and 6 ' Article 6(2) Article 7(1) Article 114 Article 7 Article 8 Articles 94 to 97 ' Article 9 Article 51 Article 8(1) Article 10(1) Articles 87(1) and 89 (2) Article 8(2) Article 10(2) Article 87(10) and Article 87(11) first subparagraph Article 8(3) Article 10(3) Article 89(7) Article 8(4) Article 10(4) Article 91 Article 9(1) Article 11(1) Article 52(3) ' Article 11(2) Article 52(6) ' Article 11(3) Article 52(4) and (5) ' Article 11(4) ' ' Article 11(5) Article 52(7) Article 9(2) Article 11 (6) Article 52(8) Article 9(3) Article 11(8) Article 11(3) Article 9(4) Article 11(12) Article 52(12) Article 9(5) Article 11(7) ' Article 9(6) Article 11(9) Article 53(1) Article 9(7) Article 11(10) Article 53(4) Article 9(8) Article 11(11) Article 56(2) Article 9(9) Article 11(13) Article 59 Article 9(10) Article 11(14) Article 4(5) and Article 122 third paragraph ' Article 12 Article 22 ' Article 12a Article 17 Article 9a(1) first indent Article 13(1)(c) ' Article 9a(1) second indent Article 13(1)(d) Article 4(1) ' Article 13(1)(a) Article 51(3)(a) and Article 51(6) ' Article 13(1)(b) Article 51(3)(b) and Article 51(6) Article 10 Article 15 Articles 62 to 82 Article 10a(1), second sentence of Article 10a(2) and Article 10a(3) Article 14(1), second sentence of Article 14(2) and Article 14(3) Articles 29(4), 30 and 31 Article 10a(2), first sentence Article 14(2) first sentence Article 11(1) Article 10b Article 14a Articles 33 and 34 Article 10c Article 14b Article 98 Article 11(1) Article 16(1) Articles 42 and 43 Article 11(2) Article 16(2) Article 36 Article 11(3) Article 16(3) Article 46(4) Article 11(4) Article 16(4) ' Article 11(5) Article 16(5) Article 56(5) Article 11(6) Article 16(6) Article 56(4) Article 11(7) Article 16(7) Articles 38(2) and 44(2) Article 12 Article 17 Article 20 Article 13 Article 18 Articles 94 to 97 Article 14 Article 19 Article 99 Article 15 Article 20 Article 109 Article 15a Article 20a Article 102 Article 16 Article 22 ' Article 17 Article 23 ' ' Article 21 ' Released Actions
3251 MDR Database MDRQ ANNEX XVI LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2) Released Actions
3252 MDR Database MDRQ 1. Contact lenses or other items intended to be introduced into or onto the eye. Released Actions
3253 MDR Database MDRQ 2. Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of tattooing products and piercings. Released Actions
3254 MDR Database MDRQ 3. Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing. Released Actions
3255 MDR Database MDRQ 4. Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty. Released Actions
3256 MDR Database MDRQ 5. High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment. Released Actions
3257 MDR Database MDRQ 6. Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain. Released Actions
3129 MDR Database MDRQ ANNEX XV CLINICAL INVESTIGATIONS Released Actions
3130 MDR Database MDRQ CHAPTER I GENERAL REQUIREMENTS Released Actions
3131 MDR Database MDRQ 1. Ethical principles Released Actions
3132 MDR Database MDRQ Each step in the clinical investigation, from the initial consideration of the need for and justification of the study to the publication of the results, shall be carried out in accordance with recognised ethical principles. Released Actions
3133 MDR Database MDRQ 2. Methods Released Actions
3134 MDR Database MDRQ 2.1. Clinical investigations shall be performed on the basis of an appropriate plan of investigation reflecting the latest scientific and technical knowledge and defined in such a way as to confirm or refute the manufacturer's claims regarding the safety, performance and aspects relating to benefit-risk of devices as referred to in Article 62(1); the clinical investigations shall include an adequate number of observations to guarantee the scientific validity of the conclusions. Released Actions
3135 MDR Database MDRQ The rationale for the design and chosen statistical methodology shall be presented as further described in Section 3.6 of Chapter II of this Annex. Released Actions
3136 MDR Database MDRQ 2.2. The procedures used to perform the clinical investigation shall be appropriate to the device under investigation. Released Actions
3137 MDR Database MDRQ 2.3. The research methodologies used to perform the clinical investigation shall be appropriate to the device under investigation. Released Actions
3138 MDR Database MDRQ 2.4. Clinical investigations shall be performed in accordance with the clinical investigation plan by a sufficient number of intended users and in a clinical environment that is representative of the intended normal conditions of use of the device in the target patient population. Released Actions
3139 MDR Database MDRQ Clinical investigations shall be in line with the clinical evaluation plan as referred to in Part A of Annex XIV. Released Actions
3140 MDR Database MDRQ 2.5. All the appropriate technical and functional features of the device, in particular those involving safety and performance, and their expected clinical outcomes shall be appropriately addressed in the investigational design. Released Actions
3141 MDR Database MDRQ A list of the technical and functional features of the device and the related expected clinical outcomes shall be provided. Released Actions
3142 MDR Database MDRQ 2.6. The endpoints of the clinical investigation shall address the intended purpose, clinical benefits, performance and safety of the device. Released Actions
3143 MDR Database MDRQ The endpoints shall be determined and assessed using scientifically valid methodologies. Released Actions
3144 MDR Database MDRQ The primary endpoint shall be appropriate to the device and clinically relevant. Released Actions
3145 MDR Database MDRQ 2.7. Investigators shall have access to the technical and clinical data regarding the device. Released Actions
3146 MDR Database MDRQ Personnel involved in the conduct of an investigation shall be adequately instructed and trained in the proper use of the investigational device, and as regards the clinical investigation plan and good clinical practice. Released Actions
3147 MDR Database MDRQ This training shall be verified and where necessary arranged by the sponsor and documented appropriately. Released Actions
3148 MDR Database MDRQ 2.8. The clinical investigation report, signed by the investigator, shall contain a critical evaluation of all the data collected during the clinical investigation, and shall include any negative findings. Released Actions
3149 MDR Database MDRQ CHAPTER II DOCUMENTATION REGARDING THE APPLICATION FOR CLINICAL INVESTIGATION Released Actions
3150 MDR Database MDRQ For investigational devices covered by Article 62, the sponsor shall draw up and submit the application in accordance with Article 70 accompanied by the following documents: Released Actions
3151 MDR Database MDRQ 1. Application form Released Actions
3152 MDR Database MDRQ The application form shall be duly filled in, containing information regarding: Released Actions
3153 MDR Database MDRQ 1.1. name, address and contact details of the sponsor and, if applicable, name, address and contact details of its contact person or legal representative in accordance with Article 62(2) established in the Union; Released Actions
3154 MDR Database MDRQ 1.2. if different from those in Section 1.1, name, address and contact details of the manufacturer of the device intended for clinical investigation and, if applicable, of its authorised representative; Released Actions
3155 MDR Database MDRQ 1.3. title of the clinical investigation; Released Actions
3156 MDR Database MDRQ 1.4. status of the clinical investigation application (i.e. first submission, resubmission, significant amendment); Released Actions
3157 MDR Database MDRQ 1.5. details and/or reference to the clinical evaluation plan; Released Actions
3158 MDR Database MDRQ 1.6. If the application is a resubmission with regard to a device for which an application has been already submitted, the date or dates and reference number or numbers of the earlier application or in the case of significant amendment, reference to the original application. Released Actions
3159 MDR Database MDRQ The sponsor shall identify all of the changes from the previous application together with a rationale for those changes, in particular, whether any changes have been made to address conclusions of previous competent authority or ethics committee reviews; Released Actions
3160 MDR Database MDRQ 1.7. if the application is submitted in parallel with an application for a clinical trial in accordance with Regulation (EU) No 536/2014, reference to the official registration number of the clinical trial; Released Actions
3161 MDR Database MDRQ 1.8. identification of the Member States and third countries in which the clinical investigation is to be conducted as part of a multicentre or multinational study at the time of application; Released Actions
3162 MDR Database MDRQ 1.9. a brief description of the investigational device, its classification and other information necessary for the identification of the device and device type; Released Actions
3163 MDR Database MDRQ 1.10. information as to whether the device incorporates a medicinal substance, including a human blood or plasma derivative or whether it is manufactured utilising non-viable tissues or cells of human or animal origin, or their derivatives; Released Actions
3164 MDR Database MDRQ 1.11. summary of the clinical investigation plan including the objective or objectives of the clinical investigation, the number and gender of subjects, criteria for subject selection, whether there are subjects under 18 years of age, design of the investigation such as controlled and/or randomised studies, planned dates of commencement and of completion of the clinical investigation; Released Actions
3165 MDR Database MDRQ 1.12. if applicable, information regarding a comparator device, its classification and other information necessary for the identification of the comparator device; Released Actions
3166 MDR Database MDRQ 1.13. evidence from the sponsor that the clinical investigator and the investigational site are capable of conducting the clinical investigation in accordance with the clinical investigation plan; Released Actions
3167 MDR Database MDRQ 1.14. details of the anticipated start date and duration of the investigation; Released Actions
3168 MDR Database MDRQ 1.15. details to identify the notified body, if already involved at the stage of application for a clinical investigation; Released Actions
3169 MDR Database MDRQ 1.16. confirmation that the sponsor is aware that the competent authority may contact the ethics committee that is assessing or has assessed the application; and Released Actions
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