on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL

on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices

1.INTRODUCTION

Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices and Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices were adopted on 5 April 2017 and entered into force on 25 May 2017. Regulation (EU) 2017/745 applies since 26 May 2021 . Regulation (EU) 2017/746 will apply from 26 May 2022 .

Medical devices and in vitro diagnostic medical devices have a fundamental role in saving lives by providing healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease. Regulations (EU) 2017/745 and (EU) 2017/746 aim to provide a robust, transparent and sustainable regulatory framework in order to ensure a high level of safety and performance of medical devices and in vitro diagnostic medical devices, while supporting innovation.

Regulations (EU) 2017/745 and (EU) 2017/746 empower the Commission to adopt several delegated acts. The Commission is required to report to the European Parliament and the Council on the delegations of power not later than nine months before the end of the five-year period.

2.LEGAL BASIS

With this report, the Commission meets the reporting requirements established in Article 115(2) of Regulation (EU) 2017/745 and Article 108(2) of Regulation (EU) 2017/746. 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 ), 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.

3.EXERCISE OF THE DELEGATIONS

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 has been applicable since 26 May 2021 and Regulation (EU) 2017/746 will apply from 26 May 2022. Hence, there is at present only limited experience on their application in practice. Further explanations are provided below for each of the empowerments.

·Products without an intended medical purpose

Article 1(5) of Regulation (EU) 2017/745 empowers the Commission to adopt delegated acts to amend Annex XVI to that Regulation. Annex XVI lists groups of products without an intended medical purpose as referred to in Article 1(2). 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 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, in order to maintain consistency with that Recommendation.

·Elements to be included in the technical documentation and technical documentation on post-market surveillance

Article 10(4) of Regulations (EU) 2017/745 and (EU) 2017/746 empowers the Commission to adopt delegated acts to amend, in the light of technical progress, the elements to be included in the technical documentation and technical documentation on post-market surveillance pursuant to Annexes II and III to Regulations (EU) 2017/745 and (EU) 2017/746. 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.