Medical device CE marking

2022-12

The sponsor of a performance study is required to submit an application/notification to the Member State(s) in which a performance study is to be conducted, accompanied by the documentation referred to in Chapter I of Annex XIV of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR). The application/notification must be submitted by means of the electronic system referred to in Article 69 of the IVDR.

In the absence of the European database on medical devices (EUDAMED), a series of performance study application/notification documents have been created to support performance study procedures with respect to the IVDR.

These documents include:

• Performance study – application/notification form under the IVDR
• Addendum to the performance study application/notification form for:
  • Additional performance device(s) (section 3)
  • Additional comparator device(s) (section 4)
  • Additional site(s) (section 5)
• Performance study supporting documents – Appendix of documents to attach
• Checklist of general safety and performance requirements, standards, common specifications and scientific opinions

The document can be downloaded from our library: MDCG 2022-19

Source: European Commission

2022-12

The MDCG has issued 2 new documents:

• MDCG 2022-18 – MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate – 9 December 2022
• MDCG 2022-17 – MDCG position paper on ‘hybrid audits’ –  6 December 2022

The documents can be downloaded in our library: MDCG 2022-18 and MDCG 2022-17

Source: European Commission

2022-12

The official journal of the European Union now includes two Commission Implementing Regulations on Annex XVI of the Medical Devices Regulation 2017/745 (MDR)

Regulation 2022/2346 related to Common Specifications for Annex XVI products (products without intended medical purpose). It concerns following groups of active products:

• contact lenses
• products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy, with the exception of tattooing products and piercings
• substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing
• equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty
• high intensity electromagnetic radiation (for example, infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment
• equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain

Regulation 2022/2347 related to reclassification of groups of certain active products without an intended medical purpose. It concerns following groups of active products:

• high intensity electromagnetic radiation emitting equipment
• equipment intended to be used to reduce, remove or destroy adipose tissue
• equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain

The Regulations can be downloaded from our library: 2022/2346 and 2022/2347

Source: European Commission

2022-11

The focus of the 2022 edition of the Global Atlas is to point out how the status of medical device topics supports or hinders the accomplishment of the Sustainable Development Goals (SDGs) and supports the increased access to priority medical devices (including in vitro diagnostics) for emergencies, wellbeing, and universal health coverage (UCH).

The 194 country profiles incorporate facts indicating the national status of medical devices in areas such as:

• medical device policies,
• regulations,
• incorporation,
• lists,
• inventories,
• nomenclature,
• health technology assessment,
• management, and
• biomedical engineering resources.

The document can be downloaded from our library

Source: World Health Organization (WHO)

2022-10

Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorized representative. The term ‘device’ will be understood to include medical devices, accessories for medical devices, products listed in Annex XVI of the MDR, in vitro diagnostic medical devices, accessories for in vitro diagnostic medical devices and also, custom-made devices.
For manufacturers who are not established in the Union the authorized representative plays a pivotal role in ensuring the compliance of the devices produced by those manufacturers and in serving as their contact person established in the Union. Article 11 of the Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) outlines the obligations of and introduces enhanced responsibility for the authorized representative.

The document can be downloaded in our library

Source: European Commission

2022-10

The MDCG issued a new revision of the MDCG 2021-22:

MDCG 2021-22 Rev.1 Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/74

Source: European Commission

2022-09

This guidance document outlines the activities to be performed by notified bodies as part of the appropriate surveillance defined in Article 110(3) last subparagraph IVDR. To clarify elements to be verified by notified bodies, this guidance document also covers requirements concerning certain manufacturers’ obligations, especially in respect of their quality management system.

The document applies to notified bodies that have lawfully issued certificates under the IVDD, regardless of whether or not those notified bodies have applied for designation or are designated under the IVDR (see MDCG 2019-10 rev.18) as long as the respective authority responsible for notified bodies has the right to and does monitor the notified body’s activities under Article 110(3) IVDR.

The document can be downloaded in our library

Source: European Commission

2022-08

On August 26, 2022, the MDCG endorsed MDCG 2022-14 Position Paper with a list of actions to increase the capacity of notified bodies and the preparedness of manufacturers, in an effort to facilitate the transition to the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).

The document can be downloaded in our library

Source: European Commission

2022-7

On July 13 the European Commission published MDCG 2022-12: Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices)

This document provides guidance to Member States and other relevant parties on the application of certain IVDR provisions during the absence
of Eudamed. To that end, this guidance intends to describe harmonised administrative practices and alternative technical solutions for the
exchange of information until Eudamed becomes fully functional.

The document can be downloaded in our library

Source: European Commission

2022-07

The European Commission has adopted common specifications for several types of high-risk diagnostics, such as HIV tests and SARS-CoV-2 tests. The specifications set uniform and rigorous benchmarks for tests across the EU, clarifying the requirements for market actors and protecting EU patients.

The document can be downloaded in our library

Source: European Commission