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# Regulation Tracker Subject Status
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
3258 MDR Database MDRQ ANNEX XVII CORRELATION TABLE 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
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
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
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
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
3252 MDR Database MDRQ 1. Contact lenses or other items intended to be introduced into or onto the eye. 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
3250 MDR Database MDRQ ' Discussion and overall conclusions covering safety and performance results, assessment of risks and clinical benefits, discussion of clinical relevance in accordance with clinical state of the art, any specific precautions for specific patient populations, implications for the investigational device, limitations of the investigation. Released Actions
3249 MDR Database MDRQ ' Summary of serious adverse events, adverse device effects, device deficiencies and any relevant corrective actions. Released Actions
3248 MDR Database MDRQ ' Results of the clinical investigation covering, with rationale and justification, subject demographics, analysis of results related to chosen endpoints, details of subgroup analysis, as well as compliance with the CIP, and covering follow-up of missing data and of patients withdrawing from the clinical investigation, or lost to follow-up. Released Actions
3247 MDR Database MDRQ ' A summary of the clinical investigation plan covering objectives, design, ethical aspects, monitoring and quality measures, selection criteria, target patient populations, sample size, treatment schedules, follow-up duration, concomitant treatments, statistical plan, including hypothesis, sample size calculation and analysis methods, as well as a justification. Released Actions
3246 MDR Database MDRQ ' Investigational device description, in particular clearly defined intended purpose. Released Actions
3245 MDR Database MDRQ The completion date of the investigation, and in particular details of early termination, temporary halts or suspensions of investigations. Released Actions
3244 MDR Database MDRQ ' A summary of the investigation covering the title, purpose of the investigation, description of the investigation, investigational design and methods used, the results of the investigation and conclusion of the investigation. Released Actions
3243 MDR Database MDRQ ' Details of the author and date of the report. Released Actions
3242 MDR Database MDRQ ' Cover/introductory page or pages indicating the title of the investigation, the investigational device, the single identification number, the CIP number and the details with signatures of the coordinating investigators and the principal investigators from each investigational site. Released Actions
3241 MDR Database MDRQ 7. The Sponsor shall prepare a clinical investigation report which includes at least the following: Released Actions
3240 MDR Database MDRQ 6. The Sponsor shall provide evidence that the investigation is being conducted in line with good clinical practice, for instance through internal or external inspection. Released Actions
3239 MDR Database MDRQ 5. The Sponsor shall complete the follow-up of investigation subjects. Released Actions
3238 MDR Database MDRQ 4. The Sponsor shall appoint a monitor that is independent from the investigational site to ensure that the investigation is conducted in accordance with the CIP, the principles of good clinical practice and this Regulation. Released Actions
3237 MDR Database MDRQ Each Member State shall require that this documentation is kept at the disposal of the competent authorities for the period referred to in the first subparagraph in case the sponsor, or its contact person or legal representative as referred to in Article 62(2) established within its territory, goes bankrupt or ceases its activity prior to the end of this period. Released Actions
3236 MDR Database MDRQ In the case of implantable devices, the period shall be at least 15 years. Released Actions
3235 MDR Database MDRQ 3. The documentation mentioned in this Annex shall be kept for a period of at least 10 years after the clinical investigation with the device in question has ended, or, in the event that the device is subsequently placed on the market, at least 10 years after the last device has been placed on the market. Released Actions
3234 MDR Database MDRQ 2. The Sponsor shall have an agreement in place to ensure that any serious adverse events or any other event as referred to in Article 80(2) are reported by the investigator or investigators to the sponsor in a timely manner. Released Actions
3233 MDR Database MDRQ If the sponsor is not the natural or legal person responsible for the manufacture of the investigational device, that obligation may be fulfilled by that person on behalf of the sponsor. Released Actions
3232 MDR Database MDRQ 1. The sponsor shall undertake to keep available for the competent national authorities any documentation necessary to provide evidence for the documentation referred to in Chapter II of this Annex. Released Actions
3231 MDR Database MDRQ CHAPTER III OTHER OBLIGATIONS OF THE SPONSOR Released Actions
3230 MDR Database MDRQ 4.6. Full details of the available technical documentation, for example detailed risk analysis/management documentation or specific test reports, shall, upon request, be submitted to the competent authority reviewing an application. Released Actions
3229 MDR Database MDRQ ' a description of measures that will be implemented in case of a data security breach in order to mitigate the possible adverse effects. Released Actions
3228 MDR Database MDRQ ' a description of measures that will be implemented to ensure confidentiality of records and personal data of subjects; and Released Actions
3227 MDR Database MDRQ ' organisational and technical arrangements that will be implemented to avoid unauthorised access, disclosure, dissemination, alteration or loss of information and personal data processed; Released Actions
3226 MDR Database MDRQ 4.5. Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data, in particular: Released Actions
3225 MDR Database MDRQ 4.4. Documents to be used to obtain informed consent, including the patient information sheet and the informed consent document. Released Actions
3224 MDR Database MDRQ 4.3. Proof of insurance cover or indemnification of subjects in case of injury, pursuant to Article 69 and the corresponding national law. Released Actions
3223 MDR Database MDRQ Where according to national law the opinion or opinions of the ethics committee or committees is not required at the time of the submission of the application, a copy of the opinion or opinions shall be submitted as soon as available. Released Actions
3222 MDR Database MDRQ 4.2. Where applicable according to national law, copy of the opinion or opinions of the ethics committee or committees concerned. Released Actions
3221 MDR Database MDRQ 4.1. A signed statement by the natural or legal person responsible for the manufacture of the investigational device that the device in question conforms to the general safety and performance requirements apart from the aspects covered by the clinical investigation and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subject. Released Actions
3220 MDR Database MDRQ 4. Other information Released Actions
3219 MDR Database MDRQ 3.19. Bibliography. Released Actions
3218 MDR Database MDRQ 3.18. List of the technical and functional features of the device, with specific mention of those covered by the investigation. Released Actions
3217 MDR Database MDRQ 3.17. Policy as regards the establishment of the clinical investigation report and publication of results in accordance with the legal requirements and the ethical principles referred to in Section 1 of Chapter I. Released Actions
3216 MDR Database MDRQ 3.16. A description of the arrangements for taking care of the subjects after their participation in the clinical investigation has ended, where such additional care is necessary because of the subjects' participation in the clinical investigation and where it differs from that normally expected for the medical condition in question. Released Actions
3215 MDR Database MDRQ Such procedures shall for implantable devices, cover as a minimum traceability. Released Actions
3214 MDR Database MDRQ 3.15. Criteria and procedures for follow-up of subjects following the end, temporary halt or early termination of an investigation, for follow-up of subjects who have withdrawn their consent and procedures for subjects lost to follow-up. Released Actions
3213 MDR Database MDRQ 3.14. Safety reporting, including definitions of adverse events and serious adverse events, device deficiencies, procedures and timelines for reporting. Released Actions
3212 MDR Database MDRQ 3.13. Description of the Informed consent process. Released Actions
3211 MDR Database MDRQ 3.12. Statement of compliance with the recognised ethical principles for medical research involving humans, and the principles of good clinical practice in the field of clinical investigations of devices, as well as with the applicable regulatory requirements. Released Actions
3210 MDR Database MDRQ 3.11. Accountability regarding the device, in particular control of access to the device, follow-up in relation to the device used in the clinical investigation and the return of unused, expired or malfunctioning devices. Released Actions
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