Medical device CE marking

2024-07

MedTech Europe published a template Manufacturer’s Declaration to facilitate the declaration of manufacturers with respect to Regulation (EU) 2024/1860 and:

• The extended transitional periods for devices for which the conformity assessment procedure pursuant to Directive 98/79/EC (IVDD) did not require the involvement of a notified body and/or
• The validity of certificates issued under Directive 98/79/EC (IVDD) (Directive Certificate) 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 In Vitro Diagnostics 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 document can be downloaded in our library

Source: MedTech Europe

Please note that a template Manufacturer’s Declaration in relation to Regulation (EU) 2023/607 can be downloaded in our library here.

2024-07

The MDCG published revision 1 of the document on July 2nd, 2024. The document aims to provide guidance on different aspects related to standards in the medical devices sector in support of the requirements laid down in the applicable EU legislation, taking into account its specificities.

The document can be downloaded in our library

Source: European Commission

2024-06

The European Commission has published guidance on the clinical evaluation of orphan medical devices.

Orphan devices are medical devices or their accessories, which are intended to be used for diseases or conditions affecting only a small number of individuals each year. Often, they are used to treat a rare disease or medical condition for which very few diagnostic or therapeutic options exist. Orphan devices can be crucial to fulfil an otherwise unmet medical need.

Today’s guidance provides criteria for determining when a medical device or an accessory for a medical device should be regarded as ‘orphan device’ under the Medical Devices Regulation 2017/745 (MDR). It aims to guide manufacturers and notified bodies when applying the MDR’s clinical evidence requirements and help overcome some of the challenges that lead to delays in patient access to orphan devices. The guidance includes the possibility for manufacturers and notified bodies to seek advice from European Medicines Agency expert panels on the orphan device status and the clinical data needed for their clinical evaluation.

The document can be downloaded in our library

Source: European Commission

2024-06

This document (revision 1) aims to provide guidance to the authorities responsible for notified bodies and joint assessment teams when conducting assessments of conformity assessments bodies (CABs) that apply for designation as a notified body (NB) in the field of medical devices and/or in vitro diagnostic medical devices, and re-assessments of NBs.
Furthermore, this guide is intended to bring consistency and to align the working practices of the different designating authorities in the Member States, regarding the assessment, designation, notification and re-assessment of CABs and NBs.

The revision 1 document can be downloaded in our library

Source: European Commission

2024-01

The MDCG issued 4 device specific guidances on the vigilance system for CE-marked devices:

• MDCG 2024-1-1 – DSVG 01: Devices for Cardiac Ablation
• MDCG 2024-1-2 – DSVG 02: Coronary Stents and associated delivery systems
• MDCG 2024-1-3 – DSVG 03: Cardiac Implantable Electronic Devices (CIEDs)
• MDCG 2024-1-4 – DSVG 04: Breast Implants 
• MDCG 2024-1-5 – DSVG 05: Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence

And also a template:

• MDCG 2024-1 – DSVG 00: Device Specific Vigilance Guidance (DSVG) Template

The documents can be downloaded in our library (see links above)

Source: European Commission

2024-05

The MDCG revised guidance 2022-4 on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD.

Revision 2:
Adjustments all over the document to align it to Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations
(EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.

Revision 1:
Adjustments all over the document to align it to MDCG 2022-15 and to reflect the views of MDCG as expressed in action n.3 of MDCG 2022-14.

MDCG 2022-4 discusses:
Article 120(2) and 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR) state that devices which are covered by valid certificates issued by a notified body under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) or the Medical Devices Directive 93/42/EEC (MDD) may be placed on the market or put into service after the date of application of the MDR (26 May 2021) and no later than 26 May 2024 under certain conditions.

The abovementioned conditions require that the notified body that issued the certificate under the MDD or the AIMDD continues carrying out appropriate surveillance with respect to all applicable requirements relating to the devices it has certified. Therefore, it is important for manufacturers, notified bodies and national authorities to get clarity on activities to be part of the appropriate surveillance referred to in Article 120(3) of the MDR.

To appropriately address application of transitional provisions to devices covered by certificates according to MDD or the AIMDD, this guidance, drafted in line with MDCG 2021-25 on application of MDR requirements to ‘legacy devices’, should be read in conjunction with guidance MDCG 2020-3 on significant changes.

The document discusses following topics:
– Requirements in respect to the manufacturer’s quality management system and related obligations
– Surveillance according to Article 120(3) MDR
– Possible scenarios for the surveillance according to Article 120(3) MDR

The updated guidance can be downloaded from our library

Source: European Commission

2024-4

The European Commission published MDCG 2024-5 Guidance on content of the Investigator’s Brochure for clinical investigations of medical devices.

When a sponsor of a clinical investigation shall submit an application according to article 70(1) of the MDR, the application shall be accompanied by the documentation referred to in Chapter II of Annex XV of the MDR. The Investigator’s Brochure (IB) is part of the required documentation and is one of the means by which the sponsor is to fulfil the requirement in section 2.7 of Chapter I of Annex XV of the MDR which states that the investigator shall have access to technical and clinical data regarding the device that is being investigated. This includes the intended purpose(s), design, the basic fundamental scientific principles behind the design and the level of objective evidence already in place, to assure its safety and functionality during the investigation.

This guidance document is intended to support sponsors in developing their IB by describing in greater detail what type of information is expected in the respective IB sections, in order to preempt questions from the competent authorities during the assessment of the clinical investigation application. The guidance is based on the requirements of both the MDR and ISO14155:2020 as well as experience from the competent authorities.

The document can be downloaded in our library

Source: European Commission

2024-4

The European Commission published revision 1 of the Summary of safety and performance template.

The document can be downloaded in our library

Source: European Commission

2024-04

The European Commission published MDCG 2024-4 Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 .

This guidance outlines the procedures for safety reporting in performance studies in the absence of the Eudamed module or when Eudamed is not yet fully functional (see also sections 5.1 and 5.2 in this guidance).

The document also defines SAE reporting modalities and includes a summary tabulation reporting format.

The document can be downloaded in our library

Source: European Commission

2024-04

The European Commission published the final report on the Study on the implementation of Article 17 of Regulation (EU) 2017/745 on medical devices on the EU market.

The study started in December 2022 and was performed over 14 months.  The study main objective was to evaluate how the provisions established in the MDR have been implemented in European countries and how such provisions operate.

In the context of the study, a dashboard has been developed. The dashboard (click on the arrows at the bottom of the dashboard to scroll through the different pages) presents an overview of the mapping activities within the study regarding the reprocessing and reuse of single-use-devices in the EU.

The final report can be downloaded in our library

Source: European Commission