Medical device CE marking

2023-07

On July 18, 2023, the European Commission published Revision 1 of the Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.

The amendment of the MDR and of the IVDR through Regulation (EU) 2023/607 aims to ensure a high level of public health protection, including patient safety and an avoidance of shortages of medical devices needed for the smooth functioning of healthcare services, without lowering current quality or safety requirements. For that purpose, manufacturers and notified bodies are given sufficiently more time to carry out, in accordance with the MDR, the conformity assessment of devices covered by a certificate or a declaration of conformity issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC.

Moreover, the deletion of the ‘sell off’ date in the MDR and the IVDR aims to prevent unnecessary disposal of safe devices. The answers to the questions have been developed taking into account the objectives pursued by the amendment with a view to making best use of the additional time provided by the extension of the MDR transitional period.

Regulation (EU) 2023/607 and the Q&A can be downloaded in our library.

Source: European Commission

2023-06

In June the MDCG published an addendum to MDCG 2022-18, the MDCG considers in this document that the application of Article 97 MDR in accordance with MDCG 2022-18 to situations where a MDD/AIMDD certificate has expired prior to the issuance of a MDR certificate has achieved its objective and is not relevant any more.

The MDCG recommends that national CAs limit the application of Article 97 MDR as set out in MDCG 2022-18 to very exceptional situations, e.g. where the national competent authority (CA) has received information justifying the application of Article 97 MDR prior to 20 March 2023.

The addendum can be downloaded in our library

Source: europa.eu

2023-06

MedTech Europe is making a template Manufacturer’s Declaration available to facilitate the declaration of manufacturers with respect to Regulation (EU) 2023/607 and:

• The validity of certificates issued for Legacy Devices under Council Directive 90/385/EEC or Active Implantable Medical Devices (AIMDD) or Council Directive 93/42/EEC on Medical Devices (MDD) (Directive Certificates) and/or
• The compliance of the Legacy Devices and their manufacturer with the conditions for the continued placing on the market and putting into service.

Any manufacturer may freely use this template to make their own declaration of the above. It may also be completed by the authorised representative on behalf of the manufacturer. The way in which the manufacturer declares their compliance with the applicable conditions is disclosed by the manufacturer in the completed form.
The template consists of two parts:

• A text part with selectable portions of text as they apply and
• A schedule which lists the devices which the manufacturer intends to cover in its Declaration

The template can be downloaded in our library

Source: MedTech Europe

Update 2024-07: A Manufacturer Declaration in relation to Regulation (EU) 2024/1860 can be downloaded in our library here

2023-05

The MDCG revised guidance 2020-3 on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD.

Revision 1:
Adjustments all over the document to align it to Regulation (EU) 2023/607 and guidance MDCG 2022-2

Article 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR), last amended by Regulation (EU) 2023/607, states that devices which continue to comply with the AIMDD or MDD may be placed on the market or put into service until 31 December 20271 or 31 December 20282, as applicable, provided the conditions set out in Article 120(3c) MDR are fulfilled.

These devices are called ‘legacy devices’ and in line with MDCG Guidance Document 2021-253, ‘legacy devices’ should be understood as devices, which, in accordance with the MDR’s transitional provisions, are placed on the market after the MDR’s date of application (i.e. 26 May 2021) if certain conditions are fulfilled. Those devices can be:

• devices which are class I devices under Directive 93/42/EEC (MDD), for which an EC declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure under the MDR requires the involvement of a notified body;
• devices covered by a valid EC certificate issued in accordance with Directive 90/385/EEC (AIMDD) or the MDD prior to 26 May 2021.4

The conditions are set out in Article 120(3c) MDR and include, among others, that legacy devices must continue to comply with the AIMDD/MDD5, as applicable, and that there are no significant changes in the design or intended purpose of the device6. Therefore, it is important for manufacturers and notified bodies to have a clear understanding as to what changes to design or intended purpose would be considered ‘significant’.

The updated guidance can be downloaded from our library

Source: European Commission

2023-05

This document is intended to provide Commission guidance, in accordance with Article 77(6) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (hereafter: the MDR), for the content and structure of the summary of the clinical investigation report.

This guidance aims to ensure that the summary of the clinical investigation report presents information about the design, conduct, analysis and results of the clinical investigation in terms and in a format that are easily understandable to the intended user of the medical device.

According to Article 77 (5) of the MDR, the sponsor of a clinical investigation shall submit a report of the clinical investigation within one year of the end of the clinical investigation or within three months of the early termination and this report shall be accompanied by a summary. The minimum requirements of the clinical investigation report are outlined in Section 7, Chapter III of Annex XV of the MDR. Section 7, Chapter III of Annex XV of the MDR also outlines what will be covered by the summary, namely:

• Title of the clinical investigation
• Purpose of the clinical investigation
• Description of the investigation, investigational design and methods used
• Results of the investigation
• Conclusion of the investigation

According to Article 77(5) of the MDR, the report and summary shall be submitted to Member States in which the clinical investigation was conducted by means of the electronic system referred to in Article 73 of the MDR. According to Article 77(7) of the MDR, the report and the summary shall become publicly accessible through the electronic system referred to in Article 73 of the MDR, at the latest when the device is registered in accordance with Article 29 of the MDR and before it is placed on the market. In cases of early termination or temporary halt, the summary and the report shall become publicly accessible immediately after submission.

The document can be downloaded from our library

Source: European Commission

2023-01

Medical devices can be manufactured and used within EU health institutions (in-house devices), on a non-industrial scale, to address the specific needs of target patient groups which cannot be met, or cannot be met at the appropriate level of performance, by an equivalent CE-marked device available on the market. In-house medical devices are exempted from most of the provisions of Regulations (EU) 2017/745 (medical devices Regulation, MDR) and (EU) 2017/746 (in vitro diagnostic medical devices Regulation, IVDR), provided the health institution adheres to the conditions laid out in Article 5(5) of the relevant Regulation.

In order to ensure the highest level of health protection, Article 5(5) sets a number of rules regarding the manufacture and use of such in-house medical devices. The provisions in Article 5(5) are the basis for the regulatory control and oversight of in house devices.

This document provides guidance on the application of some of these rules. It is written for healthcare professionals and researchers of health institutions aiming to design, manufacture, modify and use in-house devices. In addition, this guidance document intends to foster harmonised application of Article 5(5) by the national competent authorities.

The document can be downloaded in our library.

Source: European Commission

2023-01

The templates for “List of Standard Fees” provided in this guidance document are intended to assist notified bodies defining their list of fees for publication in accordance with MDR Article 50 and IVDR Article 46. Notified bodies can decide the way how they charge for their services and should have documented procedures relating to fees charged for conformity assessment activities. The fee setting should be transparent, items should be clearly indicated in the published list of standard fees. The published list needs to cover all activities corresponding to the scope of the notified body’s designation and the conformity assessment activities which are regularly offered.

The document can be downloaded in our library.

Source: European Commission

2023-01

On January 6, 2023, the Commission adopted a proposal to give more time to certify medical devices to mitigate the risk of shortages. The proposal introduces a longer transition period to adapt to new rules, as foreseen under the Medical Devices Regulation. The new deadlines depend on the medical devices’ risk class and will ensure continued access to medical devices for patients. It will also allow medical devices placed on the market in accordance with the current legal framework and that are still available to remain on the market (i.e., no ‘sell-off’ date).

The press release can be found via this link.

2022-12

The Periodic Safety Update Report (PSUR) has been introduced in Article 86 of the MDR. The introduction of the PSUR requirement under the MDR requires a more consistent, standardized and systematic review of all Post-Market Surveillance (PMS) data by manufacturers of class IIa, class IIb and class III devices.

The PSUR summarizes the results and conclusions of the analysis of the post-market surveillance data gathered as a result of the Post-Market Surveillance Plan. The range of PMS data and level of detail of information examined in a PSUR, the modalities
for aggregating and assessing the data or the grouping of devices within the same PSUR will depend mainly on the type of device(s) covered, the time span during which the manufacturer has placed them on the EU market and the post-market experience gained with these devices.

The main objective of this guidance document is to assist manufacturers to implement the legal requirements laid down in Article 86 MDR. However, manufacturers should have reasonable time to adapt their quality management systems and sufficient flexibility when they draw up and update a PSUR as long as they can demonstrate that it is in line with Article 86 MDR.

Moreover, PSURs already drawn up or in the process of being prepared when this guidance is published should not be expected to have followed this guidance, as long as those PSURs comply with the legal requirements laid down in Article 86 MDR.

The document can be downloaded in our library

Source: European Commission

 

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.

Additionally, the sponsor of a performance study is required to notify the Member State(s) in which a performance study is being or is to be conducted if it intends to introduce modifications to a performance study that are likely to have a substantial impact on the safety, health or rights of the subjects or on the robustness or reliability of the data generated by the performance study by means of the same electronic system.

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 – see MDCG 2022-19.

To add to these documents, a template for ‘Substantial modification of performance study under Regulation (EU) 2017/746’ is also provided.

The document can be downloaded in our library: MDCG 2022-20

Source: European Commission