The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024
Write the words of this act the way you think they should read. Solon shows your change as a redline against the published text and pins it to that exact text, so it can never be applied to wording you did not see.
Change 1
34 New regulation A11 (legal representatives and contact persons for clinical investigations)
In Part 3 (clinical investigations under Regulation (EU) 2017/745), before regulation 11 insert— Legal representatives and contact persons for clinical investigations A11. (1) The first subparagraph of Article 62(2) (requirement to have a legal representative established in the Union) does not apply to a clinical investigation conducted in Northern Ireland if all of the following conditions are met— (a) the clinical investigation is also being conducted in Great Britain; (b) the clinical investigation is not also being conducted in a Member State; (c) the sponsor— (i) is established in Great Britain, or (ii) has a written agreement with a legal representative established in Great Britain who is responsible for ensuring compliance with the sponsor’s obligations pursuant to Regulation (EU) 2017/745; (d) the sponsor has a contact person established in Northern Ireland in respect of the clinical investigation. (2) A contact person referred to in this regulation must be the addressee for all communications with the sponsor provided for in Regulation (EU) 2017/745 and any communication with that contact person is deemed to be a communication with the sponsor. (3) The agreement referred to in paragraph (1)(c)(ii) must provide for— (a) the legal representative to be responsible for ensuring compliance with the sponsor’s obligations pursuant to Regulation (EU) 2017/745, (b) the legal representative to immediately inform the sponsor of all communications received in its capacity as the sponsor’s legal representative, and (c) the sponsor to share with its legal representative all communications and documentation necessary to enable the legal representative to fulfil its obligations under this regulation. (4) A legal representative referred to in paragraph (1)(c)(ii) must have a written agreement with the contact person to provide for— (a) the contact person to immediately inform the legal representative of all communications received in its capacity as the sponsor’s contact person, and (b) the legal representative to share with the contact person all communications and documentation necessary to enable the contact person to fulfil its obligations under this regulation. (5) Where the sponsor is established in Great Britain, the sponsor must have a written agreement with the contact person to provide for— (a) the contact person to immediately inform the sponsor of all communications received in its capacity as the sponsor’s contact person, and (b) the sponsor to share with the contact person all communications and documentation necessary to enable the contact person to fulfil its obligations under this regulation. (6) Where the sponsor has a legal representative established in Great Britain, the application form and the clinical investigation plan drawn up in accordance with chapter II of Annex XV must include the name, address and contact details of the legal representative established in Great Britain. .
34 New regulation A11 (legal representatives and contact persons for clinical investigations)
In Part 3 (clinical investigations under Regulation (EU) 2017/745), before regulation 11 insert— Legal representatives and contact persons for clinical investigations A11. (1) The first subparagraph of Article 62(2) (requirement to have a legal representative established in the Union) does not apply to a clinical investigation conducted in Northern Ireland if all of the following conditions are met— (a) the clinical investigation is also being conducted in Great Britain; (b) the clinical investigation is not also being conducted in a Member State; (c) the sponsor— (i) is established in Great Britain, or (ii) has a written agreement with a legal representative established in Great Britain who is responsible for ensuring compliance with the sponsor’s obligations pursuant to Regulation (EU) 2017/745; (d) the sponsor has a contact person established in Northern Ireland in respect of the clinical investigation. (2) A contact person referred to in this regulation must be the addressee for all communications with the sponsor provided for in Regulation (EU) 2017/745 and any communication with that contact person is deemed to be a communication with the sponsor. (3) The agreement referred to in paragraph (1)(c)(ii) must provide for— (a) the legal representative to be responsible for ensuring compliance with the sponsor’s obligations pursuant to Regulation (EU) 2017/745, (b) the legal representative to immediately inform the sponsor of all communications received in its capacity as the sponsor’s legal representative, and (c) the sponsor to share with its legal representative all communications and documentation necessary to enable the legal representative to fulfil its obligations under this regulation. (4) A legal representative referred to in paragraph (1)(c)(ii) must have a written agreement with the contact person to provide for— (a) the contact person to immediately inform the legal representative of all communications received in its capacity as the sponsor’s contact person, and (b) the legal representative to share with the contact person all communications and documentation necessary to enable the contact person to fulfil its obligations under this regulation. (5) Where the sponsor is established in Great Britain, the sponsor must have a written agreement with the contact person to provide for— (a) the contact person to immediately inform the sponsor of all communications received in its capacity as the sponsor’s contact person, and (b) the sponsor to share with the contact person all communications and documentation necessary to enable the contact person to fulfil its obligations under this regulation. (6) Where the sponsor has a legal representative established in Great Britain, the application form and the clinical investigation plan drawn up in accordance with chapter II of Annex XV must include the name, address and contact details of the legal representative established in Great Britain. .
One line that says what changes, such as "Halve the dog tax".
Who it helps, what it costs, what it fixes. It is what persuades people to support it.
How this law is officially changed
Solon does not know this law's official route yet. The proposal is recorded all the same, and the route appears here once its source is added.
A proposal here is not law. Support on Solon is evidence that people want the change; the official route says what it takes to make it law.
Sign in to file your proposal. What you have written stays on this page.
Sign in to file itThink it through
Ask what your change would do, who would gain and who would bear a cost, and where something like it is already law. The assistant reads your draft as it stands, cites the law and the studies it finds, and takes no side. What you file stays yours.