Split (1)

train · 233 rows

Subsets and Splits

No community queries yet

The top public SQL queries from the community will appear here once available.

instruction stringclasses 6 values	input stringlengths 395 4k	output stringlengths 312 312
List and explain the regulatory requirements for medical devices.	02017R0745 — EN — 10.01.2025 — 005.001 — 201 4.1. In addition to the obligations laid down in Section 2, the manufacturer shall lodge with the notified body an application for assessmen t of the technical documentation relating to the device which it plans t o place on the market or put into service and which is ...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 201 4.1. In addition to the obligations laid down in Section 2, the manufacturer shall lodge with the notified body an application for assessmen t of the technical documentation relating to the device which it plans t o place on the market or put into s...
Summarize the content of the article and explain its significance in medical device regulation.	02017R0745 — EN — 10.01.2025 — 005.001 — 202 4.9. The notified body shall provide the manufacturer with a re port on the technical documentation assessment, including a clinical evalua tion assessment report. If the device conforms to the relevant provi sions of this Regulation, the notified body shall issue an EU...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 202 4.9. The notified body shall provide the manufacturer with a re port on the technical documentation assessment, including a clinical evalua tion assessment report. If the device conforms to the relevant provi sions of this Regulation, the notified bo...
Summarize the content of the article and explain its significance in medical device regulation.	02017R0745 — EN — 10.01.2025 — 005.001 — 203 (iii) a significantly increased rate of serious incidents repor ted in accordance with Article 87 in respect of a specific category or group of devices, whether to provide a scientific opinion on the clinical evaluat ion assessment report of the notified body based o...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 203 (iii) a significantly increased rate of serious incidents repor ted in accordance with Article 87 in respect of a specific category or group of devices, whether to provide a scientific opinion on the clinical evaluat ion assessment report of the n...
Summarize the content of the article and explain its significance in medical device regulation.	02017R0745 — EN — 10.01.2025 — 005.001 — 204 5.2. Procedure in the case of devices incorporating a medicinal substance (a) Where a device incorporates, as an integral part, a substan ce which, if used separately, may be considered to be a medicinal product wi thin the meaning of point 2 of Article 1 of Directive...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 204 5.2. Procedure in the case of devices incorporating a medicinal substance (a) Where a device incorporates, as an integral part, a substan ce which, if used separately, may be considered to be a medicinal product wi thin the meaning of point 2 of Ar...
Summarize the content of the article and explain its significance in medical device regulation.	02017R0745 — EN — 10.01.2025 — 005.001 — 205 (g) Where the medicinal products authority consulted obtains in formation on the ancillary substance, which could have an impact on the r isk or benefit previously established concerning the incorporation of the substance into the device, it shall advise the notified bo...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 205 (g) Where the medicinal products authority consulted obtains in formation on the ancillary substance, which could have an impact on the r isk or benefit previously established concerning the incorporation of the substance into the device, it shall ad...
Summarize the content of the article and explain its significance in medical device regulation.	02017R0745 — EN — 10.01.2025 — 005.001 — 206 their derivatives into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit-risk ratio of the addition of the tissues o r cells of human origin or their derivatives in the device. It shal...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 206 their derivatives into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit-risk ratio of the addition of the tissues o r cells of human origin or their derivatives in...
Provide a summary and key takeaways from the given text.	02017R0745 — EN — 10.01.2025 — 005.001 — 207 CHAPTER III ADMINISTRATIVE PROVISIONS 7. The manufacturer or, where the manufacturer does not have a registered place of business in a Member State, its authorised representat ive shall, for a period ending no sooner than 10 years, and in the case of imp lantable de...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 207 CHAPTER III ADMINISTRATIVE PROVISIONS 7. The manufacturer or, where the manufacturer does not have a registered place of business in a Member State, its authorised representat ive shall, for a period ending no sooner than 10 years, and in the case...
Summarize the content of the article and explain its significance in medical device regulation.	02017R0745 — EN — 10.01.2025 — 005.001 — 208 ANNEX X CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION 1. EU type-examination is the procedure whereby a notified body ascertains and certifies that a device, including its technical documentat ion and relevant life cycle processes and a corresponding representativ...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 208 ANNEX X CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION 1. EU type-examination is the procedure whereby a notified body ascertains and certifies that a device, including its technical documentat ion and relevant life cycle processes and a corresp...
Summarize the content of the article and explain its significance in medical device regulation.	02017R0745 — EN — 10.01.2025 — 005.001 — 209 (d) in circumstances in which the clinical evidence is based pa rtly or totally on data from devices which are claimed to be similar or equival ent to the device under assessment, assess the suitability of using su ch data, taking into account factors such as new indica...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 209 (d) in circumstances in which the clinical evidence is based pa rtly or totally on data from devices which are claimed to be similar or equival ent to the device under assessment, assess the suitability of using su ch data, taking into account factor...
Provide a summary and key takeaways from the given text.	02017R0745 — EN — 10.01.2025 — 005.001 — 210 5.3. Changes to the intended purpose and conditions of use of t he approved device, with the exception of limitations of the intended purpo se and conditions of use, shall necessitate a new application for a co nformity assessment. 6. Specific additional procedures ...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 210 5.3. Changes to the intended purpose and conditions of use of t he approved device, with the exception of limitations of the intended purpo se and conditions of use, shall necessitate a new application for a co nformity assessment. 6. Specific addi...
Summarize the content of the article and explain its significance in medical device regulation.	02017R0745 — EN — 10.01.2025 — 005.001 — 211 ANNEX XI CONFORMITY ASSESSMENT BASED ON PRODUCT CONFORMITY VERIFICATION 1. The objective of the conformity assessment based on product conformity verification is to ensure that devices conform to the type for which an EU type-examination certificate has been issued,...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 211 ANNEX XI CONFORMITY ASSESSMENT BASED ON PRODUCT CONFORMITY VERIFICATION 1. The objective of the conformity assessment based on product conformity verification is to ensure that devices conform to the type for which an EU type-examination certific...
Summarize the content of the article and explain its significance in medical device regulation.	02017R0745 — EN — 10.01.2025 — 005.001 — 212 That documentation shall, in particular, include an adequate de scription of all elements listed in points (a), (b), (d) and (e) of Section 2.2 of Annex IX. 6.3. The first and second paragraph of Section 2.3 of Annex IX shall apply. If the quality management system i...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 212 That documentation shall, in particular, include an adequate de scription of all elements listed in points (a), (b), (d) and (e) of Section 2.2 of Annex IX. 6.3. The first and second paragraph of Section 2.3 of Annex IX shall apply. If the quality...
Summarize the content of the article and explain its significance in medical device regulation.	02017R0745 — EN — 10.01.2025 — 005.001 — 213 — the decisions and reports from the notified body as referred to in Sections 2.3, 3.3 and 3.4 of Annex IX. Section 8 of Annex IX shall apply. 10. Application to class IIa devices 10.1. By way of derogation from Section 5, by virtue of the EU declaration of conform...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 213 — the decisions and reports from the notified body as referred to in Sections 2.3, 3.3 and 3.4 of Annex IX. Section 8 of Annex IX shall apply. 10. Application to class IIa devices 10.1. By way of derogation from Section 5, by virtue of the EU dec...
Summarize the content of the article and explain its significance in medical device regulation.	02017R0745 — EN — 10.01.2025 — 005.001 — 214 12. The manufacturer shall take all the measures necessary to e nsure that the manufacturing process produces devices which conform to the typ e described in the EU type-examination certificate and to the req uirements of the Regulation which apply to them. Prior to the...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 214 12. The manufacturer shall take all the measures necessary to e nsure that the manufacturing process produces devices which conform to the typ e described in the EU type-examination certificate and to the req uirements of the Regulation which apply t...
List and explain the regulatory requirements for medical devices.	02017R0745 — EN — 10.01.2025 — 005.001 — 215 17. Administrative provisions The manufacturer or its authorised representative shall, for a period ending no sooner than 10 years, and in the case of implantable devices no sooner than 15 years, after the last device has been placed on the mar ket, keep at the dispo...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 215 17. Administrative provisions The manufacturer or its authorised representative shall, for a period ending no sooner than 10 years, and in the case of implantable devices no sooner than 15 years, after the last device has been placed on the mar ket...
Summarize the content of the article and explain its significance in medical device regulation.	02017R0745 — EN — 10.01.2025 — 005.001 — 216 ANNEX XII CERTIFICATES ISSUED BY A NOTIFIED BODY CHAPTER I GENERAL REQUIREMENTS 1. Certificates shall be drawn up in one of the official langua ges of the Union. 2. Each certificate shall refer to only one conformity assessme nt procedure. 3. Certificates shall...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 216 ANNEX XII CERTIFICATES ISSUED BY A NOTIFIED BODY CHAPTER I GENERAL REQUIREMENTS 1. Certificates shall be drawn up in one of the official langua ges of the Union. 2. Each certificate shall refer to only one conformity assessme nt procedure. 3...
Summarize the content of the article and explain its significance in medical device regulation.	02017R0745 — EN — 10.01.2025 — 005.001 — 217 3. unique number identifying the certificate; 4. if already issued, the SRN of the manufacturer referred to i n to Article 31(2); 5. date of issue; 6. date of expiry; 7. data needed for the unambiguous identification of the device or devices where applicable as s...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 217 3. unique number identifying the certificate; 4. if already issued, the SRN of the manufacturer referred to i n to Article 31(2); 5. date of issue; 6. date of expiry; 7. data needed for the unambiguous identification of the device or devices w...
Summarize the content of the article and explain its significance in medical device regulation.	02017R0745 — EN — 10.01.2025 — 005.001 — 218 ANNEX XIII PROCEDURE FOR CUSTOM-MADE DEVICES 1. For custom-made devices, the manufacturer or its authorised representative shall draw up a statement containing all of the following infor mation: — the name and address of the manufacturer, and of all manufact uring s...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 218 ANNEX XIII PROCEDURE FOR CUSTOM-MADE DEVICES 1. For custom-made devices, the manufacturer or its authorised representative shall draw up a statement containing all of the following infor mation: — the name and address of the manufacturer, and of ...
Summarize the requirements and procedures for conducting clinical investigations on medical devices.	02017R0745 — EN — 10.01.2025 — 005.001 — 219 ANNEX XIV CLINICAL EVALUATION AND POST-MARKET CLINICAL FOLLOW-UP PART A CLINICAL EVALUATION 1. To plan, continuously conduct and document a clinical evalua tion, manu facturers shall: (a) establish and update a clinical evaluation plan, which shal l include at ...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 219 ANNEX XIV CLINICAL EVALUATION AND POST-MARKET CLINICAL FOLLOW-UP PART A CLINICAL EVALUATION 1. To plan, continuously conduct and document a clinical evalua tion, manu facturers shall: (a) establish and update a clinical evaluation plan, whic...
Summarize the content of the article and explain its significance in medical device regulation.	02017R0745 — EN — 10.01.2025 — 005.001 — 220 2. The clinical evaluation shall be thorough and objective, and take into account both favourable and unfavourable data. Its depth and ex tent shall be proportionate and appropriate to the nature, classification, intended purpose and risks of the device in question, a...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 220 2. The clinical evaluation shall be thorough and objective, and take into account both favourable and unfavourable data. Its depth and ex tent shall be proportionate and appropriate to the nature, classification, intended purpose and risks of the d...
Summarize the content of the article and explain its significance in medical device regulation.	02017R0745 — EN — 10.01.2025 — 005.001 — 221 6. PMCF shall be performed pursuant to a documented method laid down in a PMCF plan. 6.1. The PMCF plan shall specify the methods and procedures for proactively collecting and evaluating clinical data with the aim of: (a) confirming the safety and performance of th...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 221 6. PMCF shall be performed pursuant to a documented method laid down in a PMCF plan. 6.1. The PMCF plan shall specify the methods and procedures for proactively collecting and evaluating clinical data with the aim of: (a) confirming the safety a...
Summarize the content of the article and explain its significance in medical device regulation.	02017R0745 — EN — 10.01.2025 — 005.001 — 222 ANNEX XV CLINICAL INVESTIGATIONS CHAPTER I GENERAL REQUIREMENTS 1. Ethical principles Each step in the clinical investigation, from the initial consi deration of the need for and justification of the study to the publication of t he results, shall be carried ou...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 222 ANNEX XV CLINICAL INVESTIGATIONS CHAPTER I GENERAL REQUIREMENTS 1. Ethical principles Each step in the clinical investigation, from the initial consi deration of the need for and justification of the study to the publication of t he results, ...
Summarize the content of the article and explain its significance in medical device regulation.	02017R0745 — EN — 10.01.2025 — 005.001 — 223 CHAPTER II DOCUMENTATION REGARDING THE APPLICATION FOR CLINICAL INVESTIGATION For investigational devices covered by Article 62, the sponsor shall draw up and submit the application in accordance with Article 70 accompanie d by the following documents: 1. Applicat...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 223 CHAPTER II DOCUMENTATION REGARDING THE APPLICATION FOR CLINICAL INVESTIGATION For investigational devices covered by Article 62, the sponsor shall draw up and submit the application in accordance with Article 70 accompanie d by the following docu...
List and explain the regulatory requirements for medical devices.	02017R0745 — EN — 10.01.2025 — 005.001 — 224 1.13. evidence from the sponsor that the clinical investigator and the investi gational site are capable of conducting the clinical investigat ion in accordance with the clinical investigation plan; 1.14. details of the anticipated start date and duration of the inves...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 224 1.13. evidence from the sponsor that the clinical investigator and the investi gational site are capable of conducting the clinical investigat ion in accordance with the clinical investigation plan; 1.14. details of the anticipated start date and du...
Summarize the content of the article and explain its significance in medical device regulation.	02017R0745 — EN — 10.01.2025 — 005.001 — 225 2.6. In the case of devices that incorporate a medicinal substa nce, including a human blood or plasma derivative or devices manufactured utilis ing non-viable tissues or cells of human or animal origin, or their derivatives, detailed information on the medicinal subst...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 225 2.6. In the case of devices that incorporate a medicinal substa nce, including a human blood or plasma derivative or devices manufactured utilis ing non-viable tissues or cells of human or animal origin, or their derivatives, detailed information on...
Define the key term or concept related to medical device regulation.	02017R0745 — EN — 10.01.2025 — 005.001 — 226 3.3. Risks and clinical benefits of the device to be examined, with justification of the corresponding expected clinical outcomes in the clinical investi gation plan. 3.4. Description of the relevance of the clinical investigation in the context of the state of the ...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 226 3.3. Risks and clinical benefits of the device to be examined, with justification of the corresponding expected clinical outcomes in the clinical investi gation plan. 3.4. Description of the relevance of the clinical investigation in the context o...
Summarize the content of the article and explain its significance in medical device regulation.	02017R0745 — EN — 10.01.2025 — 005.001 — 227 3.15. Criteria and procedures for follow-up of subjects followi ng the end, temporary halt or early termination of an investigation, for fo llow-up of subjects who have withdrawn their consent and procedures for su bjects lost to follow-up. Such procedures shall for imp...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 227 3.15. Criteria and procedures for follow-up of subjects followi ng the end, temporary halt or early termination of an investigation, for fo llow-up of subjects who have withdrawn their consent and procedures for su bjects lost to follow-up. Such proc...
Summarize the content of the article and explain its significance in medical device regulation.	02017R0745 — EN — 10.01.2025 — 005.001 — 228 CHAPTER III OTHER OBLIGATIONS OF THE SPONSOR 1. The sponsor shall undertake to keep available for the compet ent national authorities any documentation necessary to provide evidence for the docu mentation referred to in Chapter II of this Annex. If the spons or is n...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 228 CHAPTER III OTHER OBLIGATIONS OF THE SPONSOR 1. The sponsor shall undertake to keep available for the compet ent national authorities any documentation necessary to provide evidence for the docu mentation referred to in Chapter II of this Annex. ...
Summarize the requirements and procedures for conducting clinical investigations on medical devices.	02017R0745 — EN — 10.01.2025 — 005.001 — 229 — A summary of the clinical investigation plan covering objecti ves, design, ethical aspects, monitoring and quality measures, selec tion criteria, target patient populations, sample size, treatment sc hedules, follow-up duration, concomitant treatments, statistical pla...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 229 — A summary of the clinical investigation plan covering objecti ves, design, ethical aspects, monitoring and quality measures, selec tion criteria, target patient populations, sample size, treatment sc hedules, follow-up duration, concomitant treatme...
Define the key term or concept related to medical device regulation.	02017R0745 — EN — 10.01.2025 — 005.001 — 230 ANNEX XVI LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2) 1. Contact lenses or other items intended to be introduced into or onto the eye. 2. Products intended to be totally or partially introduced into the human body th...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 230 ANNEX XVI LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2) 1. Contact lenses or other items intended to be introduced into or onto the eye. 2. Products intended to be totally or partially introduced into...
Summarize the content of the article and explain its significance in medical device regulation.	02017R0745 — EN — 10.01.2025 — 005.001 — 231 ANNEX XVII CORRELATION TABLE 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 ...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 231 ANNEX XVII CORRELATION TABLE 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) ...
Summarize the content of the article and explain its significance in medical device regulation.	02017R0745 — EN — 10.01.2025 — 005.001 — 232 Council Directive 90/385/EEC Council Directive 93/42/EEC This Regulation — 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 ...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 232 Council Directive 90/385/EEC Council Directive 93/42/EEC This Regulation — 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) Ar...
Summarize the content of the article and explain its significance in medical device regulation.	02017R0745 — EN — 10.01.2025 — 005.001 — 233 Council Directive 90/385/EEC Council Directive 93/42/EEC This Regulation 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 ...	Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 233 Council Directive 90/385/EEC Council Directive 93/42/EEC This Regulation 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...