flow-meter™ | The European regulatory system with the new MDR - part 2

flow-meter™ | The European regulatory system with the new MDR - part 2
In May 2017, the EU Regulation 2017/745 was published and the Directive 93/42/EEC abrogated.
Due to the scenario induced by the Covid-19 pandemic, the applicability date was postponed by one year, to 26 May 2021, but the end date of the transition period, 26 May 2024, the last day on which medical device certificates could remain valid, was unchanged.
The timeframe set for the Regulation to come into force proved to be insufficient for the stakeholders to bring about all the required changes. In fact, the designated Notified Bodies, which to date number around 40, did not turn out to be sufficient and adequately structured to be able to assess and certify the more than 21,000 medical devices actually on the market by 26 May 2024. In addition, many manufacturers, especially small and medium-sized enterprises, are unable to demonstrate compliance with the MDR requirements. As a result, many devices will not be ready to be legitimately placed on the market in time for the new safety and performance requirements.
The organizational and structural specifications required of manufacturers and Notified Bodies for the migration of the CE marking of class I medical devices from the previous marking conducted in accordance with Directive 93/42/EEC to the procedures of the New Regulation, the lack of qualified resources across Europe and, above all, the time required for the validation of the new marking procedures, which is very onerous, have caused a strong push to request the postponement of the initially set deadlines.
In order to avoid the risk of a shortage of medical devices on the market and to ensure that products that have already started the assessment process by a Notified Body (and therefore more compliant with the new safety and performance specifications) are placed on the market, the European Commission published a proposal to amend the Regulation on 6 January 2023. This aims to extend the period of validity of certificates and the transition period during which devices can be placed on the market. The proposal was approved by the European Parliament on 16 February 2023 and was consequently adopted by the European Council. Thus, on 20 March 2023, Regulation (EU) 2023/607, which amends the transitional period of the MDR (EU Regulation 2017/745) and the IVMDR (EU Regulation 2017/746), was published in the Official Journal with immediate entry into force.
This Regulation postpones the deadlines initially set, creating new deadlines and new validity periods for legacy marking certificates provided that manufacturers have filed a migration application for legacy devices and have accepted the cost estimate formulated by the relevant Notified Body. This scenario significantly alters the relationship prevailing in the free market: the costs associated with the implementation of migration procedures are significantly higher than the previous ones also due to the need to perform repeated and in-depth checks, year by year, on the technical documentation of the devices, on the manufacturer's quality system and on the whole chain of critical suppliers that contribute to the production of devices themselves or of their component parts. Not only that, the absence of a stable and harmonized technical and clinical regulatory framework that is consistent with and meets the General Safety and Performance Requirements required by the Regulation still makes it difficult for the end user or the person guiding the choice of products often offered in public tenders and contracts to make a direct and perceptible technical comparison. The final price of the device is ruled by conditions that cannot be easily changed or easily increased. It must also be considered that not all operating realities can withstand the impact of costs that are at times difficult to estimate and plan, related to the need for repeated corrective action plans, necessary to remedy situations of non-compliance highlighted during the technical, clinical and system evaluation phases envisaged in the five-year period of validity of each certificate. This scenario is serious, to the point that the Extension Regulation itself establishes primarily the possibility of a further extension of the deadlines if, having reached the currently indicated due dates, migration is still not possible. The most evident disadvantages, which first and foremost affect those realities that have been forced to reach the objective of completing the migration process with great difficulty and significant costs, moreover also in a period also impacted by the black swan of the Covid 19 pandemic, are those of comparing much more significant marking costs with the costs of the migration process.
More Information:
www.flowmeter.it
/ flow-meter-s.p.a .