Commonwealth Consolidated Regulations

THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 - SCHEDULE 3AA

Note:   See Part   4A.

1   Purpose of this Schedule

    This Schedule sets out requirements for the purposes of making, suspending, revoking or varying a conformity assessment body determination under Part   4A of these Regulations.

2   EU Regulations

  (1)   The requirements are:

  (a)   to the extent the determination covers medical devices that are not IVD medical devices--the requirements of the EU medical devices regulation, as modified by clauses   3, 4 and 5 of this Schedule; and

  (b)   to the extent the determination covers IVD medical devices--the requirements of the EU IVD regulation, as modified by clauses   3, 4 and 6 of this Schedule.

  (2)   The EU medical devices regulation is Annex VII to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5   April 2017 on medical devices, as in force from time to time.

  (3)   The EU IVD regulation is Annex VII to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5   April 2017 on in vitro diagnostic medical devices, as in force from time to time.

3   Modifications of EU Regulations--general

  (1)   For the purposes of subclause   2(1), the EU medical devices regulation and the EU IVD regulation (the EU regulations ) are taken to be modified as set out in this clause.

General modifications

  (2)   A reference in the EU regulations to a term mentioned in column 1 of an item of the following table is taken to be a reference to the term mentioned in column 2 of that item.

  (3)   Subclause   (2) has effect subject to subclause   (6) and clauses   5 and 6.

Example:   Item   4 of the table in subclause   (2) does not apply to the reference to "authorised representative" in Section   4.3 of each EU regulation (see subparagraph   (6)(c)(i) of this clause).

  (4)   For the purposes of the EU regulations:

  (a)   an activity is taken to be designated, in relation to an Australian conformity assessment body, if the activity relates to conformity assessment procedures covered by the body's conformity assessment body determination; and

  (b)   a device is taken to be designated, in relation to an Australian conformity assessment body, if the device is covered by the body's conformity assessment body determination.

  (5)   A reference in the EU regulations to CS is disregarded.

Note:   CS is short for common specifications.

Modifications of specific provisions

  (6)   Each EU regulation is taken to be modified in the following ways:

  (a)   the following provisions are disregarded:

  (i)   Sections   1.1.1, 1.2.6 and 1.2.8;

  (ii)   the words "unless liability is assumed by the Member State in question in accordance with national law or that Member State is directly responsible for their conformity assessment" in Section   1.4.1;

  (iii)   the words "or previously applicable law within a notified body" in Section   3.2.3;

  (vi)   the words "as referred to in Annexes II and III" in point (a) of Section   4.5.2;

  (vii)   all the words after "resultant decision" in Section   4.8;

  (b)   in Section   3.1.1:

  (i)   the words "performance and safety of devices" are replaced with the words "compliance with the essential principles"; and

  (ii)   the words "those set out in Annex I" are replaced with the words "the essential principles";

  (ba)   in Section   3.3.1, the words "the authority responsible for notified bodies" are replaced with the words "the Secretary";

  (c)   in Section   4.3:

  (i)   a reference to an authorised representative is taken to be a reference to an applicant authorised by the manufacturer; and

  (ii)   a reference to the corresponding Annex is taken to be a reference to the corresponding part of Schedule   3 to these Regulations; and

  (iii)   the word "approval" is replaced with the word "assessment";

  (d)   in Section   4.5.1, a reference to relevant Annexes is taken to be a reference to Schedule   3 to these Regulations;

  (da)   in Section   4.5.2, the words "post - market surveillance information" are replaced with the words "information from post - marketing requirements mentioned in Schedule   3 to these Regulations";

  (e)   in Section   4.5.3, the words "For assessment of the technical documentation conducted in accordance with Chapter II of Annex IX" are replaced with the words "For the assessment of compliance of manufacturers with clause   1.6 of Schedule   3 to these Regulations";

  (ea)   in Section   4.6, the words "personnel in designating authorities" are replaced with the words "the Secretary";

  (f)   in Section   4.10:

  (ii)   the words "laid down in the relevant Annexes" are replaced with the words "for a quality management system set out in Schedule   3 for the conformity assessment procedure applied by the manufacturer"; and

  (iii)   the words "summary of safety and performance" are replaced with the words "evidence of compliance with the essential principles";

  (g)   in Section   4.11, the word "reviews" (wherever occurring) is replaced with the word "assessments".

4   Additional requirements

  (1)   For the purposes of subclause   2(1), the EU medical devices regulation and the EU IVD regulation (the EU regulations ) are taken to include the requirements mentioned in this clause.

Independence and impartiality

  (2)   Section   1.2 of each EU regulation includes a requirement that an Australian conformity assessment body will take action:

  (a)   to respond to any threats to its impartiality; and

  (b)   to ensure that all internal or external personnel or committees who could influence the body's certification - related activities will:

  (i)   act impartially; and

  (ii)   not allow commercial, financial or other pressures to compromise impartiality.

Liability

  (3)   Section   1.4 of each EU regulation includes a requirement that an Australian conformity assessment body will:

  (a)   document a justification for the cover and overall financial value of the liability insurance mentioned in that Section, including:

  (i)   the types of medical devices and conformity assessment procedures in relation to which the body carries on certification - related activities; and

  (ii)   the locations at which those activities are carried on; and

  (iii)   the patient risk profile of the devices; and

  (iv)   the compliance risk profiles of the manufacturing activities in relation to which the body carries on certification - related activities; and

  (b)   give this justification to the body's liability insurer, and document having done so.

Process requirements

  (4)   Section   4 of each EU regulation includes a requirement that an Australian conformity assessment body will have documented procedures in place that cover the following in relation to the body's certification - related activities:

  (a)   assigning internal or external personnel to activities on the basis of their documented competences;

  (b)   following up corrections and corrective actions by manufacturers in relation to nonconformities identified during audits or assessments.

5   Additional modifications of EU medical devices regulations

  (1)   For the purposes of subclause   2(1), the EU medical devices regulation is taken to be modified as set out in this clause.

  (2)   A reference in the EU medical devices regulation to PMCF is disregarded.

Note:   PMCF is short for post - market clinical follow - up.

  (3)   The EU medical devices regulation is modified in the following ways:

  (a)   the following provisions are disregarded:

  (i)   the last dash point of Section   1.1.6;

  (ii)   the words "the authorities responsible for notified bodies, competent authorities for medical devices in the Member States or" in Section   1.3.2;

  (iii)   the sentence "Refusals or withdrawals of applications shall be notified to the electronic system referred to in Article 57 and shall be accessible to other notified bodies." in Section   4.3;

  (iv)   the eighth dash point of Section   4.5.1;

  (v)   the words "referred to in Annexes II and III" in point (b) of Section   4.5.3;

  (vi)   the words "as specified in Section   15 of Annex XI" in point (d) of Section   4.5.3;

  (vii)   the words "as referred to in Regulation (EU) No 722/2012," in Section   4.5.6;

  (viii)   the words "for the relevant competent authority" in Section   4.5.6;

  (ix)   the words "under Article 92(2)" in Section   4.10;

  (b)   in Section   1.6.1, the words "notified body coordination group referred to in Article 49" are replaced with the word "Secretary";

  (c)   in Section   3.2.2, the words "Article 42(3)" are replaced with the words "Annex I of Commission Implementing Regulation (EU) 2017/2185 of 23   November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council (Commission Implementing (EU) 2017/2185)";

  (d)   in point (a) of Section   4.5.3, the words "Part B of Annex XI" are replaced with the words "Part   3 of Schedule   3 to these Regulations";

  (e)   in point (b) of Section   4.5.3, the words "the EU" are replaced with the words "a relevant";

  (f)   in Section   4.5.5, the words "Annex XIV" (wherever occurring) are replaced with the words "Part   8 of Schedule   3 to these Regulations";

  (g)   in Section   4.5.6:

  (i)   the words "sufficient expertise and facilities for the procedures referred to in Sections   5 and 6 of Annex IX, Section   6 of Annex X and Section   16 of Annex XI, for which they are designated" are replaced with the words "allowing for external expert opinions to be sought when required to ensure an adequate assessment of compliance with these Regulations"; and

  (ii)   the words "that Regulation" are replaced with the words "these Regulations";

  (h)   in Section   4.10, the words "observe the manufacturer's and competent authority's activities and the results of the manufacturer's investigation" are replaced with the words "observe the manufacturer's activities and the results of the manufacturer's investigation, and be aware of information relating to the Secretary's vigilance and monitoring activities that is available on the TGA's website".

6   Modifications of EU IVD regulations

  (1)   For the purposes of subclause   2(1), the EU IVD regulation is taken to be modified as set out in this clause.

  (2)   A reference in the EU IVD regulation to companion diagnostics or PMPF is disregarded.

Note:   PMPF is short for post - market performance follow - up.

  (3)   The EU IVD regulation is modified in the following ways:

  (a)   the following provisions are disregarded:

  (i)   point (g) of Section   1.1.6;

  (ii)   the words "the authorities responsible for notified bodies, competent authorities for devices in the Member States or" in Section   1.3.2;

  (iii)   the sentence "Refusals or withdrawals of applications shall be notified to the electronic system referred to in Article 52 and shall be accessible to other notified bodies." in Section   4.3;

  (iv)   the subsection headed "Verification by examination and testing of every product batch" in Section   4.5.3;

  (v)   the paragraph beginning "In the case of companion diagnostics," in Section   4.5.5;

  (vi)   the words "under to Article 87" in Section   4.10;

  (b)   in Section   1.6.1, the words "notified body coordination group referred to in Article 49 of Regulation (EU) 2017/745" are replaced with the word "Secretary";

  (c)   in Section   3.2.2:

  (i)   the words "Article 38(3)" are replaced with the words "Annex II of Commission Implementing Regulation (EU) 2017/2185 of 23   November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro medical devices under Regulation (EU 2017/746 of the European Parliament and of the Council (Commission Implementing (EU) 2017/2185)"; and

  (ii)   the words "self and near patient testing" are replaced with the words "self - testing and point of care testing";

  (d)   in Section   4.5.5, the words "sufficient expertise and facilities for the procedures referred to in Section   5 of Annex IX, for which they are designated" are replaced with the words "allowing for external expert opinions to be sought when required to ensure an adequate assessment of compliance with the essential principles and these Regulations";

  (e)   in Section   4.10, the words "observe the manufacturer's and competent authorities' activities and the results of the manufacturer's investigation" are replaced with the words "observe the manufacturer's activities and the results of the manufacturer's investigation, and be aware of information relating to the Secretary's vigilance and monitoring activities that is available on the TGA's website";

  (f)   a reference to a class B device is taken to be a reference to a Class 2 IVD medical device;

  (g)   a reference to a class C device is taken to be a reference to a Class 3 IVD medical device.

7   Expressions used in modifications

    To avoid doubt, an expression used in a modification of the EU medical devices regulation or EU IVD regulation made by this Schedule has the same meaning in that modification as it does elsewhere in these Regulations.