The Medical Devices Regulation (MDR) (EU) 2017/745 prepared by The Council and the European Parliament and enforced in May 2017 was supposed to be replaced by the new MDR (EU) 2020/561 on 26th May 2020. However, taking into consideration the current situation of COVID-19, the ratification was postponed for the 26th of May 2021.
Regarding the following statement above, pandemic coronavirus and the industry players such as manufacturers, suppliers, scientific institutions, notified bodies or safety and health of the patients, the regulations of MDR (EU) 2017/745 will remain valid for an upcoming year. This means that the transformation that is coming next year will cover a four-year transition and will cover a lot of new regulations. The main changes will be regarding mostly access to the market, cross-collaboration, and an increase in the control of the European market of medical devices.
The new regulations insight
The key improvements include the reinforcement of the common European law, more precise criteria of design, transparency, coordination, clinical investigation, and approval processes, notified bodies oversight, implementation of an “implant card” or EU coordinated procedures. This also regards new classification rules of the materials, nanomaterials, and software, authorization, or strengthening the requirements for device manufacturers and tightening market surveillance and vigilance. The European Commission outlined these also more detailed. You can read it here to fully understand the changes, start to prepare for their implementation, and comply with the requirements of the new regulations as soon as they are going to be applied.
The new rules will also indulge more advanced controls and clinical testing of the high-risk devices such as implants or consulting from the EU level expertise side before introducing them on the market. Patients will be also obligated to receive an ”implant card” where all the needed information and device identification must be included to be able to find the specific product in the, also extended, European Medical Device Database (EUDAMED). What’s also important is to instantly enhance market vigilance and surveillance in order to enable manufacturer data collection from the EU market. The new rules of Unique Device Identification (UDI) will be introduced as well.
The need for regulation transformation
The aim of the new regulations is to modernize the current healthcare system and prepare medical institutions for a more accessible and regularized market. With the new legislation coming, the sector can be developed mainly in terms of technological advancement, accessibility, documentation and regional collaboration.
In a result of new regulations, we can achieve a higher level of healthcare products safety, the free and easily accessible trade between the countries in the European Union and become a leader in the global market. The latest technological manufacturing and scientific developments ensure that the medical devices we will produce and use are being made with the highest world standards and in accordance with all requirements while combating all the weaknesses that the market has been experiencing in recent years.
How new MDR 2017/745 regulations affects Point-Of-Care 3D Printing industry?
Taking into consideration Point-Of-Care 3D Printing in the new rules of the game, it may have a positive result. The present regulations are not clear enough according to the technology application and accessibility as well as market regulations and cross-collaboration. The upcoming transformation, which will cover all the current regulatory can turn out to be a good turnaround in the industry and unlock the unlimited possibilities for its development.
How to prepare for the new regulations?
The postponement of the new regulations can be also seen as an additional advantage for the industry stakeholders. Manufacturers now have more time for notified bodies designation and new MDR requirements preparation. They can also classify their devices based on the current regulations while not being obligated do apply this to the Unique Device Identification (UDI) system yet. Now they have time to implement it and focus on the proper application of the new regulations coming in May 2021.
Are you ready for change? Leave a comment and tell us what are the the advantages and the limitations of the new regulations.