As the pandemic continues to wreak havoc on our complex healthcare systems and other health concerns remain challenging, it is a busy time for the MedTech industry. On top of organizational restructuring to accommodate present challenges, the medical industry faces another major shift globally: namely the significant changes in medical device regulations that have taken root in recent years to ensure the highest possible standard in this safety-critical industry. Read on for everything you need to know about medical device regulations in 2021, and how you can keep up!
Medical device regulation shifts are particularly pressing in Europe. In 2017, the EU mandated a transition to a stricter regulation standard that marks one of the most significant medical device regulation changes in recent decades. The change in question is the shift from the European Medical Device Directives (MDD 93/42/EC) to the European Medical Device Regulations (EU MDR 2017/745, or EU MDR). This transition demands a significant increase in medical vigilance in everything from in vitro devices to non-surgical cosmetic procedures. These changes are coming fast, with full adherence expected in EU member states as of May 26, 2021.
Initially slated for implementation in 2020, the move to EU MDR was postponed by one year to allow greater focus on Covid-19 relief. But the new launch date is fast approaching, and achieving the latest compliance standards will be no simple feat. With the regulation document presented by the EU MDR almost three times the length of the preceding Medical Device Directive, you have to pay close attention to adherence. Compared to the MDD, the new regulations place more emphasis on retaining approval than obtaining it. Safety, risk management, oversight, and data usage are more critical in the MDR than in the preceding MDD, and devices must undergo constant maintenance and evaluation to stay up to par.
Medical device regulations in 2021: What to expect
The new global standard for medical device regulations is demonstrated in two major standard changes: the EU MDR and the ISO 13485. While the EU MDR specifically governs EU member states, the content within indicates an important global shift towards traceability, transparency, and post-approval maintenance of medical devices. ISO 13485, on the other hand, can be seen as a relatively international standard, and its principles carry significant sway over the global medical device manufacturing industry.
ISO 13485 primarily regulates comprehensive quality management system requirements in medical device design and manufacturing. Its most recent iteration was established in March 2019, meaning companies have mostly undertaken their adherence measures. Unlike EU MDR, ISO 13485 2016 can be seen as more of a "facelift" to earlier regulations, as it was primarily an update on a version passed in 2003.
The EU MDR, on the other hand, is an overhaul of existing legislation meant to reframe the focuses of medical device regulation in Europe. Its broad range encompasses all medical devices, from surgical tools to veterinary and aesthetic implements. This breadth means it impacts a massive number of medical technology providers, who must all be ready to adapt in the coming months.
Both plans, but particularly the EU MDR, are centered around improving safety, traceability, and post-approval accountability in all medical devices. A central theme is rapid response and adaptation to customer complaints and operative incidents. The new standards are less focused on pre-approval, tackling medical device regulation with a lifecycle approach to promote continuous improvement and transparency.
One thing to look out for in the quest for increased traceability is the EU MDR mandate for Unique Device Identification (UDI). According to the new regulation, every device must have a device identifier (DI), and each series must have a product identifier (PI), to facilitate greater device tracking and regulatory adherence. Simultaneously, the MDR will establish a set of databases covering investigations, registrations, and post-market surveillance, working in tandem with Notified Bodies to ensure greater data accessibility and post-approval evaluation.
The EU Regulation on Medical Devices and ISO 13485 aim to improve the safety, transparency, and traceability of the regulatory system in the EU. By introducing these new measures, they will ensure that MedTech developers can quickly respond to changes on the basis of consumer safety.
EU MDR and Brexit: How the UK is keeping up
Brexit, of course, has consequences which affect nearly every industry, and medical device regulations are no exception. When the EU MDR was confirmed in 2017 with an intended 3-year rollout plan, Brexit was already firmly in scope, but the UK was still expected to comply with the new regulations and standards. And given legislative limitations, the UK cannot officially update regulations, because amendments must be orchestrated through the European Communities Act of 1972.
To address this, they have established the UK Bill, initially presented in February 2020. This act delegates regulatory updates to differing bodies based upon the field of the devices: human medicine, veterinary medicine, and medical devices. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has taken over implementing the new regulations.
Some of the biggest changes will come in certification standards. While the UK is officially not an EU entity as of 2021, medical device products created in the UK will need to achieve a CE marking. The CE mark will continue to be accepted in the UK until 2023, giving European medical device companies a grace period and allowing for the continued utilization of existing devices. UK Notified Bodies, however, can no longer issue CE markings. Conversely, companies will need to achieve the UK Conformity Assessed (UKCA) mark for UK use. These marks are non-exclusive, meaning any medical device company can simultaneously achieve both the CE and UKCA markings.
Similar to global and EU shifts, oversight remains important in post-Brexit UK medical device regulation. Every device used in the UK must register with the MHRA, and every EU company must regularly report to a UK Responsible Person with the performance data for their device. Manufacturers must provide regular vigilance reports and ensure safety compliance, as directed by the MHRA, to continue operation in the post-Brexit UK.
Get ready for it: how MedTech developers can prepare
In the new age of medical device regulations, MedTech developers need to transition towards a lifecycle approach, focusing on retaining approval rather than merely achieving it. There is a significantly greater focus on safety, vigilance, and traceability in medical device production and usage. The new standards are all focused on continued demonstrations of adherence and suitability. Data security is increasingly crucial as privacy regulations gain steam. Developers need to approach medical device manufacturing as if compliance begins with initial product development, and never ends.
The first step to preparedness is familiarizing yourself with all of the regulations - even if you think they may not apply to you. A clear understanding of ISO 13485, EU MDR, and the UK Bill will help you identify the changing standards in global medical device regulations and equip you with the knowledge to go about your own development practices flawlessly. Integrate a lifecycle approach to your development process today, and ensure that quality assessment possibilities extend far beyond your factory floor.
The best thing you can do to ensure you are up to date with medical device regulations is to leverage a requirements, risk, and test management management platform designed with the industry in mind from the ground up. A comprehensive MedTech development tool will help you bring products to market while mitigating risk and adhering to the most current standards with ease. Try seamless medical software development today.
Find out more about Intland's templates
for MedTech developers:
For medical Quality Assurance specialists, Intland offers a Medical Audit & CAPA Template. The template supports MedTech developers in controlling quality documents, streamlining compliance assessments, and accelerating audits.