The medical device regulation changes are significant inEurope. In 2017 the EU required a more stringent regulation standard, one ofthe most extensive regulatory changes for medical devices over the past fewdecades. The shift in question is the change from the European Medical Device Directives (MDD 93/42/EC) to the European Medical Device Regulation (EU MDR 2017/745, or EU MDR). This change requiresa substantial rise in medical vigilance in all aspects of cosmetic surgical devices in vitro. The changes are fast approaching, and full compliance is to the new regulations expected to be in EU member states from May 26 2021.
Initially scheduled tobe implemented by 2020. However, the transition to the EU MDR was delayed byone year to permit greater attention to the Covid-19 relief. However, the new date for launch is quickly approaching, and reaching the most current compliance standards isn't easy. With the document governing compliance issued in the EU MDR nearly three times longer than the prior Medical Device Directive, you need to pay close attention to the adherence. Compared to MDD in the MDR, the new rules emphasize maintaining approval rather than obtaining it. Safety and oversight, risk management, and data use are more crucial in the MDR than the prior MDD. The devices have to undergo regular maintenance and evaluation to remain up-to-date.
Health device regulation to beimplemented in 2021: What should we expect?
The new international norm for the regulation of medicaldevices is exemplified through two significant changes to the standard: the EUMDR and the ISO 13485. The EU MDR applies explicitly to EU members; itscontent is a considerable shift toward transparency, traceability, and post-approval maintenance for medical devices. ISO 13485, on the other hand, could be described as an internationally-based standard and its principles have a significant influence on the medical device manufacturing industry.
ISO 13485 primarilyregulates comprehensive requirements for quality management systems in thedesign of medical devices and manufacturing. It’s most recent revision was adopted in March of 2019, which means that companies have implemented mainly the necessary adherence to the requirements. Contrary to EU MDR, ISO 13485:2016 could be considered more than a "facelift" to the earlier regulationssince it was, in essence, an update of an earlier version that was approved in 2003.
The EU MDR On thecontrary, it is a revision of the current legislation that aims to redefine theprimary goals of medical device regulations in Europe. The MDR's scope is broad and covers every medical device, including surgical instruments to aesthetic and veterinary instruments. This wide range affects most medical technology firms, which should all be prepared to adjust over the next few months.
Both plans, particularly that of EU MDR, focus on improvingtraceability, safety, and post-approval accountability for every medicaldevice. The primary focus is speedy reaction and adaption to customercomplaints and surgical incidents. The new guidelines focus less on pre-approval and instead address medical device regulations using the lifecycle approach to encourage transparency and progress.
When searching toimprove transparency in the EU MDR directive to provide Unique DeviceIdentification (UDI), one thing to watch for. As per the new directive, every device should have device identification (DI). Every series must be equipped with an identification number for each product (PI) to allow better device tracking and compliance with the regulations. Additionally, the MDR will create a set of databases that cover registrations, investigations, and post market surveillance. These databases will work together and Notified Bodies to ensure greater access to data and post-approval assessment.
The EU Regulation on Medical Devices and ISO 13485 aimsto improve the safety, transparency and control in the regulation system withinthe EU.
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EU MDR as well as Brexit - How is the UK keeps up
Naturally, Brexit has implications that affect almostevery sector, as medical device regulation is not an exception. Consideringthat EU MDR was approved in 2017, with a planned 3-year implementation plan,Brexit was already firmly in the spotlight, yet the UK was not required to adhere to the new rules and regulations. Due to legislative restrictions, the UK could not officially amend regulations as changes are governed by parliament. European Communities Act of 1972.
They've created the UKBill to address this issue, originally introduced on February 20, 2020. The actdelegates regulatory amendments to various agencies based on devices that include human medicine, veterinarian medicine, and medical devices. The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) has been given the task of implementing the new regulations.
One of the mostsignificant changes will be related to the certification requirements. Althoughthe UK is not officially an EU entity from 2021, medical devices developed in the UK must be certified with a CE mark. The CEmark is still valid within the UK until2023, allowing European medical device manufacturers to extend their grace period and enable them to continue using existing medical devices. UK Notified Bodies, however, are no longer able to issue CE certifications. However, companies must obtain their UK Conformity Assessment (UKCA) mark to be eligiblefor UK use. These marks are not exclusive, and any medical device manufacturer can simultaneously receive both the CE and UKCA marks. Aswith global EU changes, supervision will remain vital in post-Brexit UK health device regulation. Each device used in the UK must be registered with MHRA, and each EU business must regularly report to the UK Responsible Person who has the performancedata of their device. Manufacturers must submit regular vigilance reports and guarantee that their devices are safe, as required by the MHRA to operate after Brexit in the UK.