CAMD announces efforts to avoid plausible future shortage of essential medical devices
On October 20-21, 2022, the 51st meeting of the European Union Competent Authorities for Medical Devices (CAMD) was held in Prague under the Czech Presidency of the Council of the European Union.
As a reminder, with the adoption of the European Medical Device Regulation (MDR) 2017/745, the regulations have changed dramatically.
The main objective of the MDR (Medical Device Regulation) is to “establish a robust, transparent, predictable and sustainable regulatory framework for medical devices, ensuring a high level of safety and health, while supporting innovation.”
The concern is that there will be a shortage of essential medical devices in the future.
CAMD spoke on this issue and announced that it will work with stakeholders to ensure a harmonized, effective and sustainable solution to this immediate problem. It will, therefore, seek to address the critical issues in the system related to certification capacity and promote the preparation of manufacturers to avoid disruptions in the supply of essential medical devices to patients and healthcare systems in Europe.
It is therefore crucial to solve the problem in the short term by undertaking a critical and broader assessment of the causes and factors that have led to the lack of certification capacity.
CAMD highlighted the urgent need to initiate an assessment of the practical implementation and functioning of the regulatory system, using as a key measure the key objectives of the MDR 2017/745, which are:
- “Establish a robust, transparent, predictable and sustainable regulatory framework for medical devices.”
- “Support innovation in Europe”
- “Ensuring the smooth functioning of the internal market”
- “Ensuring a high level of safety and health for the public.”
In addition, in order to improve efficiency in the implementation of regulatory requirements to address the difficulties related to the placing on the market of medical devices, it becomes necessary to initiate a focused discussion at the European level involving experts and decision makers from member state authorities, the European Commission, and stakeholders to identify the best way such that the European Medical Device Regulation 2017/745 MDR (Medical Device Regulation) can be supported and made applicable for the benefit of all citizens of the union.
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