Application and Notification of a Performance Study under the EU IVDR: Required Documents

The MDCG 2022-19 was published on December 2022. This document indicates a series of templates that should be used for performance study applications under the IVDR, while the respective EUDAMED module is not fully functional.

March 30, 2023

Guilherme Semedo

Application for performance studies

According to IVDR Article 66, to apply for a performance study, the sponsor must submit an application to the Member State(s) in which the study is to be conducted, accompanied by the following documentation:

Application form
Investigator’s brochure
Performance study plan
A signed statement by the manufacturer indicating that the device conforms to the general safety and performance requirements apart from the aspects covered by the study
A copy of the opinion of the ethics committee
Proof of insurance or indemnification in case of injury
Documents used to obtain informed consent
Description of the arrangements on data protection and confidentiality
Available technical documentation

The IVDR states that the application must be submitted through EUDAMED. However, in the absence of the platform, a series of performance study application documents have been created.

MDCG 2022-19

On December 2022, it was published the MDCG 2022-19 related to the performance study application documents under the IVDR.

These documents are annexed to the MDCG document and include:

Performance study – application form under the IVDR
Addendum to the performance study application form for:

Additional device(s)
Additional comparator
Additional site(s)

Performance study support documents – Documents to attach
Checklist of general safety and performance requirements, standards, common specifications and scientific opinions

These templates will be withdrawn once the EUDAMED module for performance studies is fully functional.

Performance study identification numbers

In the absence of EUDAMED, the Union-wide unique single identification number for a performance study, will be the CIV-ID which can be generated in EUDAMED2, the platform developed to support the old Directives.

Safety reporting in clinical investigations of medical devices shall be performed in line with Article 80(2) of the EU MDR. On May 2020, it was published the MDCG 2020-10/1, outlining the procedures for safety reporting in clinical investigations of medical devices under the EU MDR. However, on October 2022 the Medical Device Coordination Group (MDCG) published an updated version of the MDCG 2020-10/1, the MDCG 2020-10/1 Rev 1. This article highlights the updates included in the new revision, analysing the gaps between both documents.

Guilherme Semedo February 24, 2023

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Roles and Responsibilities of an Authorised Representative under EU MDR and IVDR

If a medical device manufacturer is not established in a Member State, the devices can only be placed on the Union market if the manufacturer designates an authorised representative. The authorised representative plays a pivotal role in ensuring the compliance of the devices with EU regulation, serving as point of contact. The obligations and responsibilities of authorised representative are outlined on Article 11 of both MDR and IVDR, but clarification of relevant requirements is described in MDCG 2022-16 of October 2022.

Guilherme Semedo February 15, 2023

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Understanding the ISO Standards Lifecycle

ISO Standards cover a huge range of activities, representing the distilled wisdom of people with expertise in their subject matter and providing the regulators with a sound basis to develop better legislation. ISO Standards are diverse, addressing from the shoe size we wear to the quality of air we breathe. The medical device sector is no exception. ISO has many International Standards and guidance documents aimed at helping the sector ensure safe and effective medical devices while meeting the multitude of national, regional and international regulatory requirements. But how exactly is a Standard developed, reviewed and withdraw?

Guilherme Semedo February 13, 2023

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Reclassification of Active Products without Intended Medical Purpose in the European Union

The Commission published the Implementing Regulation (EU) 2022/2347, laying down rules for the reclassification of several active products without an intended medical purpose mentioned in MDR annex XVI.

Guilherme Semedo January 24, 2023

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Amendments to the Transitional Provisions of the European Union MDR and IVDR

The proposed amendments aim to maintain patients’ access to a wide range of medical devices while ensuring the transition to the new framework. The ammendments proposal aims to extend the current transition period (Article 120 of the MDR), and it also deletes the ‘sell-off’ deadlines of both MDR and IVDR. The extension is staggered depending on the risk class of the device – until December 2027 for high-risk devices and December 2028 for medium and lower-risk devices.

Guilherme Semedo January 9, 2023

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EU MDR – Proposal for Extension of Transition Period

The transition to MDR has been slower than anticipated by the European Commission. Insufficient capacity of notified bodies and the low level of preparedness of manufacturers led to a proposal for extension of current MDR transition period with deadlines depending on the risk class of the devices.

Guilherme Semedo December 13, 2022

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MDCG 2022-18 – EU MDR Article 97

EU MDR Article 97 may be a temporary solution to avoid disruption of supply of Medical Devices on the EU Market. The MDCG 2022-18 presents a uniform approach for application of MDR Article 97 on non-compliant legacy devices under the conditions set by the competent authorities, while limiting the impact on the supply of safe and effective devices.

Liliana Teles December 10, 2022

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Availability of Medical Devices in Europe After MDR Implementation – Findings From Medtech Europe Survey Report

Implementation of the MDR is a top priority for the medical devices industry, which has committed significant resources to comply with the new requirements. Despite its efforts, the sector remains seriously held back by the slow and piecemeal implementation of the new regulatory framework.

Liliana Teles October 13, 2022

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EU to set Labelling Requirements for 56 additional Fragrance Allergens in Cosmetic Products

World Trade Organization (WTO) has been notified by the European Commission of a draft amendment to Regulation (EC) No 1223/2009 as regards labelling of fragrance allergens in Cosmetic Products. The proposed date of adoption of the new regulation is expected to be in the first half of 2023 and the propose date of entry in force 20 days from the publication in the Official Journal of the European Union.

Filipa Ferreira October 11, 2022

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New Amendments to the European Cosmetics Regulation – CMR Substances

The European Commission published the Commission Regulation (EU) 2022/1531, which amends Regulation (EC) No 1223/2009 in regards to the use in cosmetic products of certain substances classified as CMR. This amendment introduces new entries to Annex II and Annex III and revises an entry to Annex V to Regulation (EC) No 1223/2009.

Filipa Ferreira October 4, 2022

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Common Specifications for Class D In Vitro Diagnostic Medical Devices

On 5 of July of 2022, the European Commission published the implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746.

Guilherme Semedo August 3, 2022

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