MDCG 2022 14
MDCG position Paper – Transition to the MDR and IVDR
On 26th August MDCG [Medical Device Coordination Group] posted a position paper for the Transition to the MDR and IVDR – Notified Body Capacity and availability of medical devices and IVDs.
This document states that the MDCG recognises the fact that significant and urgent challenges remain in ensuring sufficient capacity of notified bodies and readiness of manufacturers in order to allow medical devices and in vitro diagnostic medical devices to be certified in accordance with the MDR and the IVDR within the transition periods provided for in the Regulations. According to the data collected by MDCG there are several causes that require a mix of different solutions.
During the EPSCO council meeting on 14th June 2022, several health ministers of different countries had expressed their concerns regarding several challenges brought in with the regulations. Many of these challenges and concerns if not answered or addressed by MDCG may lead to supply chain disruption affecting the supply of Medical Devices. The ministers also raised the concern of lack of access to innovative medical devices in the European Market.
In response to these concerns raised at the meeting, MDCG published this document.
The Paper highlights proposed actions which are intended to improve the efficiency of application of the regulatory requirements, rather than reducing, avoiding or removing requirements, in particular in relation to safety.
For this purpose, the MDCG lists the following actions to enhance notified body capacity, access to notified bodies and manufacturers’ preparedness in order to facilitate transition to the MDR and IVDR and to avoid shortage of medical devices.
The MDCG proposes measures in the following areas to prevent shortages of medical devices and IVDs:
- Increase notified bodies’ capacities
- Access to notified bodies
- Increase preparedness of manufacturers
- And other actions facilitating transition to MDR/IVDR and/or avoiding shortage of devices
Some Key Measures Outlined –
- The MDCG advises notified bodies to make use of hybrid audits where they consider that this would contribute to conducting the conformity assessment in a timely and efficient manner in compliance with the Regulations.
- Reduce duplication of work by developing a framework for leveraging evidence, or components thereof, from previous assessments conducted with regard to requirements under the Directive.
- With regard to ‘appropriate surveillance’ of legacy devices, the MDCG calls on notified bodies to make full use of the flexibility described already in MDCG 2022-4 on ‘appropriate surveillance under Article 120(3) MDR.
- The MDCG will review its guidance with a view to eliminate administrative workload of notified bodies
- The MDCG considers that in the framework of the development of Eudamed it should be ensured as soon as possible that notified bodies can upload relevant information machine-to-machine.
- Notified bodies should rationalise and streamline internal administrative procedures, and ensure that proper conformity assessments are carried out in a timely and efficient manner in accordance with the Regulations.
- The MDCG reminds notified bodies of their obligation to make their standard fees publicly available.
- Moreover, the MDCG calls on notified bodies to develop schemes in order to allocate capacity for SME manufacturers and first-time applicants and ensure access of SMEs and first-time applicants to notified bodies for conformity assessment.
- The MDCG reminds manufacturers of its notice MDCG 2022-11 calling on manufacturers to ensure timely compliance with MDR requirements.
- The MDCG also calls on manufacturers to ensure timely compliance with IVDR requirements as soon as possible, making use of available notified body capacities, and not wait until the end of the transition periods. The MDCG is committed to supporting the transition to the Regulations and avoid shortage of devices.
- The MDCG encourages notified bodies and manufacturers to organise structured dialogues before and during the conformity assessment process aimed at regulatory procedures where this is useful to enhance the efficiency and predictability of the conformity assessment process, while respecting the independence and impartiality of the notified body.
- In order to increase preparedness of manufacturers, especially SMEs and first-time applicants, to adapt to the high-level standards set up by the Regulations, the MDCG calls on all parties involved to continue and, where possible, to step up communication with manufacturers by means of webinars, workshops, targeted feedback and informative sessions.
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- The MDCG urges medicines authorities to accept and efficiently process consultations by notified bodies regarding medical devices incorporating an ancillary medicinal substance15 and regarding companion diagnostics.
Finally, the MDCG recalls that derogations from applicable conformity assessments procedures may be granted by competent authorities only if the use of the device concerned is in the interest of public health, patient safety or patient health. Mechanisms provided in Chapter VII of the Regulations, such as market surveillance measures, may only be applicable for devices for which manufacturers can demonstrate that they have undertaken all reasonable efforts to transition to the Regulations. MDCG will explore the application of such measures and, where relevant, work towards a coordinated, transparent and coherent approach.
This paper lists down a set of to do lists for various ecosystem members. As a committed regulatory risk partners, Med-Di-Dia and the experts are here to cut through the maze and help you navigate the Regulatory Requirements for your Medical Devices, Diagnostics and Digital Health!
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