Chapters dict | Annexes dict |
|---|---|
{
"articles": {
"Article 1": {
"heading": "Subject matter and scope",
"text": "Article 1(6) Article 1(5) Article 1(6) \n— Article 1(6) — \n— Article 1(8) Article 1(13)"
},
"Article 10": null,
"Article 100": null,
"Article 101": null,
"Article 102": null,
"Article 103": null,
... | {
"text": "met, together with the grounds, \n— where applicable, an indication that the device contains or incor porate s a medicinal substance, including a human \nblood or plasma derivative, or tissues or cells of human origin, or of animal origin as refer red to in \nRegulation (EU) No 722/2012. \n2. The manuf a... |
{
"articles": {
"Article 1": null,
"Article 10": {
"heading": "General obligations of manufacturers",
"text": "Article 10 Article 15 Articles 62 to 82 \nArticle 10a(1), second senten ce of \nArticle 10a(2) and Article 10a(3) Article 14(1), second senten ce of"
},
"Article 100": null,
"... | {
"text": "TECHNIC AL DOCUMENT ATION \nThe technical documentation and, if applicable, the summar y thereof to be drawn up by the manuf acturer shall be \npresent ed in a clear , organised, readily searc hable and unambiguous manner and shall include in particular the elements \nlisted in this Annex. \n1. DEVICE DES... |
{
"articles": {
"Article 1": null,
"Article 10": null,
"Article 100": null,
"Article 101": null,
"Article 102": null,
"Article 103": null,
"Article 104": null,
"Article 105": null,
"Article 106": null,
"Article 107": null,
"Article 108": null,
"Article 109": null,
"... | {
"text": "TEC HNIC AL DOCUMENT ATION ON POST -MARKET SUR VEILL ANCE \nThe technical documentation on post-market surveillance to be drawn up by the manuf acturer in accordance with \nArticles 83 to 86 shall be present ed in a clear , organised, readily searc hable and unambiguous manner and shall include \nin partic... |
{
"articles": {
"Article 1": null,
"Article 10": null,
"Article 100": null,
"Article 101": null,
"Article 102": null,
"Article 103": null,
"Article 104": null,
"Article 105": null,
"Article 106": null,
"Article 107": null,
"Article 108": null,
"Article 109": null,
"... | {
"text": "out in Sections 14 and 15 conf orm to the type descr ibed in the EU type-examination certificate and meet the \nrequirements of this Regulation which apply to them. \n12. The manufacturer shall take all the measures necessar y to ensure that the manufa ctur ing process produces \ndevices whic h conf orm t... |
{
"articles": {
"Article 1": null,
"Article 10": null,
"Article 100": null,
"Article 101": null,
"Article 102": null,
"Article 103": null,
"Article 104": null,
"Article 105": null,
"Article 106": null,
"Article 107": null,
"Article 108": null,
"Article 109": null,
"... | {
"text": "CE MARKING OF CONFORMIT Y \n1. The CE marking shall consist of the initials ‘CE’ taking the following form: \n2. If the CE marking is reduced or enlarg ed, the propor tions given in the above graduat ed drawing shall be respected . \n3. The various components of the CE marking shall have substantially t... |
{"articles":{"Article 1":null,"Article 10":null,"Article 100":null,"Article 101":null,"Article 102":(...TRUNCATED) | {"text":"INFOR MA TION TO BE SUBMITTED UPON THE REGISTRA TION OF DEVICES AND ECO NOMIC \nOPERA TORS (...TRUNCATED) |
{"articles":{"Article 1":null,"Article 10":null,"Article 100":{"heading":"Electronic system on marke(...TRUNCATED) | {"text":"REQUIREMENTS TO BE MET BY NOTIFIED BODIES \n1. ORGANISA TIONAL AND GENERAL REQUIREMENTS \n(...TRUNCATED) |
{"articles":{"Article 1":null,"Article 10":null,"Article 100":null,"Article 101":{"heading":"Compete(...TRUNCATED) | {"text":"CLASSIFIC ATION RULES \nCHAPTER I \nDEFINITIONS SPECIFIC TO CLASSIFIC ATION RULES \n1. DUR(...TRUNCATED) |
{"articles":{"Article 1":null,"Article 10":null,"Article 100":null,"Article 101":null,"Article 102":(...TRUNCATED) | {"text":"CONFORMIT Y ASSESSMENT BASED ON A QUALIT Y MANA GEMENT SYSTEM AND ON ASSESSMENT OF \nTECHNI(...TRUNCATED) |
{"articles":{"Article 1":null,"Article 10":null,"Article 100":null,"Article 101":null,"Article 102":(...TRUNCATED) | {"text":"CONFORMIT Y ASSESSMENT BASED ON TYPE-EXAMINA TION \n1. EU type-examination is the procedur(...TRUNCATED) |
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