REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL
26/4/2022
Pursuant to those provisions, the power to adopt delegated acts referred to in the provisions listed therein (i.e. Articles 1(5), 3, 10(4),18(3), 19(4), 27(10), 44(11), 52(5), 56(6), 61(8), 70(8) and 106(15) of Regulation (EU) 2017/745 and Articles 10(4), 17(4), 24(10), 51(6) and 66(8) of Regulation (EU) 2017/746 5 ), is conferred on the Commission for a period of five years from 25 May 2017.
Article 115(2) of Regulation (EU) 2017/745 and Article 108(2) of Regulation (EU) 2017/746 lay down that the delegations of power are to be tacitly extended for periods of identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
The Commission has not yet exercised the delegated powers conferred to it under the respective provisions of Regulations (EU) 2017/745 and (EU) 2017/746.
This is primarily due to the fact that Regulation (EU) 2017/745 [Medical Device Regulation - MDR] has been applicable since 26 May 2021 and Regulation (EU) 2017/746 will apply from 26 May 2022 [In-Vitro Diagnostic Regulations - IVDR]. Hence, there is at present only limited experience on their application in practice. Further explanations are provided below for each of the empowerments.
The report highlights the following:
- Products without an intended medical purpose
The Commission is empowered to add new groups of products in order to protect the health and safety of users, other persons or other aspects of public health. The groups of products listed in Annex XVI are still up to date.
- Amendment of the definition of ‘nanomaterial’ and related definitions
Article 3 of Regulation (EU) 2017/745 empowers the Commission to adopt delegated acts to amend the definition of ‘nanomaterial’ set out in Article 2(18) and the related definitions of ‘particle’, ‘agglomerate’ and ‘aggregate’ set out in Article 2(19), (20), (21) in light of technical and scientific progress and taking into account definitions agreed at Union and international level.
The before-mentioned definitions are based on Commission Recommendation 2011/696/EU 6 which has not yet been updated. A review of that Recommendation is ongoing and is expected to result in the adoption of a revised Recommendation and accompanying staff working document in the first half of 2022. Should the definition of ‘nanomaterial’ be amended in that Recommendation, the Commission will assess the need to amend the corresponding and related definitions in Regulation (EU) 2017/745 [Medical Device Regulation - MDR], in order to maintain consistency with that Recommendation.
- Elements to be included in the technical documentation and technical documentation on post-market surveillance
Technical progress has not yet given rise to the need for any amendments.
- Exemption from the requirement of an implant card
Article 18(3) of Regulation (EU) 2017/745 includes a list of implants exempted from the requirements of an implant card and empowers the Commission to adopt delegated acts to amend that list by adding other types of implants to it or by removing implants therefrom.
To date, no need for updating the list has arisen in view of well-established technologies or in order to protect the health and safety of patients, users or other persons or other aspects of public health.
- Minimum content of the EU declaration of conformity
Technical progress has not yet given rise to the need for an amendment.
- Information to be submitted as part of the Unique Device Identification (UDI) system
The Commission is currently preparing a delegated act pursuant to Article 27(10), point (b), of Regulation (EU) 2017/745, amending Annex VI to Regulation (EU) 2017/745 as regards UDI assignment for contact lenses.
- Frequency of complete re-assessment of notified bodies
Currently, Article 44(10) of Regulation (EU) 2017/745 and Article 40(10) of Regulation (EU) 2017/746 provide for such re-assessment three years after notification and again every fourth year thereafter. The first notified body under Regulation (EU) 2017/745 was designated in January 2019, so there is little practical experience which would have justified the adaptation of the frequency of re-assessment laid down in the Regulations.
- Exemption of certain well-established technologies from assessment of technical documentation for every single device
Article 52(5) of Regulation (EU) 2017/745 empowers the Commission to adopt delegated acts to amend the list of devices in Article 52(4), second subparagraph, of Regulation (EU) 2017/745 by adding other types of class IIb implantable devices to that list or removing devices therefrom. The list contains class IIb implantable devices exempted from the assessment of the technical documentation as specified in Section 4 of Annex IX to Regulation (EU) 2017/745 for every single device.
The assessment of at least one representative device per generic device group suffices. It may be justified in the future in view of well-established technologies to add further devices to that list or to remove devices from the list in order to protect the health and safety of patients, users or other persons or other aspects of public health.
- Minimum content of certificates issued by a notified body
Both Regulations include transitional provisions allowing devices to be placed on the market with certificates issued in accordance with the previous Directives. Therefore, there is not enough practical experience on the issuing of certificates under the Regulations which would have given rise to amend their minimum content.
- Exemption of certain well-established technologies from assessment of technical documentation for every single device and from the requirement to perform clinical investigations
It may be justified in the future in view of well-established technologies to add further devices to those lists or to remove devices from the lists in order to protect the health and safety of patients, users or other persons or other aspects of public health.
- Documentation regarding the application for clinical investigation and interventional clinical performance studies
To date, no need for updating the documentation requirements has arisen.
- Tasks of expert panels and expert laboratories
…Expert panels were designated by Commission Implementing Decision (EU) 2019/1396 8 and started their work in April 2021. Expert laboratories have not yet been designated. To date, no need for changing the tasks of expert panels or expert laboratories has arisen.
Conclusions:
The Commission sees the need for a tacit extension of the delegations of power provided for in Article 115(2) of Regulation (EU) 2017/745 and Article 108(2) of Regulation (EU) 2017/746 for a period of five years, in accordance with those Articles.
The need to develop and adopt rules based on the empowerments granted by Article 115(2) of Regulation (EU) 2017/745 and Article 108(2) of Regulation (EU) 2017/746 may arise in the future. The rationale for the delegations of power has not changed. It is important to maintain the necessary flexibility in the legal framework, to supplement or adjust it to technical and scientific developments with a view to protect health and safety of patients, users and public health in general based also on more experience gained with the application of the Regulations.
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