Medical device CE marking

MDCG 2024-10 Clinical evaluation of orphan medical devices published

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

MDCG 2022-13 Designation, re-assessment and notification of conformity assessment bodies and notified bodies – Revision 1

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

MDCG issues 1 template and 5 guidances on device specific vigilance

2024-01

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

  • MDCG 2024-1-1DSVG 01: Devices for Cardiac Ablation
  • MDCG 2024-1-2DSVG 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 2024-1DSVG 00: Device Specific Vigilance Guidance (DSVG) Template

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

Source: European Commission

MDCG revised guidance 2022-4

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

MDCG 2024-6, 7, 8 and 9 – Preliminary (re-)assessment review form templates published

2024-05

On May 15, there were 4 new MDCG Notified Body preliminary (re-) assessment review form templates published.

The documents can be downloaded in our library:

Source: European Commission

Current status MDR / IVDR Notified Bodies

2024-05

At the moment there are 49 notified bodies designated to perform audits according the MDR:

The current status of NBs under the IVDR is 12:

Source: NANDO database

MDCG 2024-5 Published on Guidance on the Investigator’s Brochure (MDR)

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

MDCG 2024-4 published on Safety reporting in performance studies of in vitro diagnostic medical devices under the IVDR

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