2022 will finally see the European Medical Regulations changing. There’s no doubt that this change will bring several multiple products into the regulatory scope previously excluded. Furthermore, it integrates some innovative industrial needs while also improving the load for post-market observation.
What Is The Scale Of The Change?
It’s essential to mention that the earlier directives that featured the Vitro Diagnostic Medical Devices Directive and the Medical Device Directive will cease to apply from the said time frame. As an alternative, the procedures that will be tasked to monitor the manufacturing of the medical devices will either be the IVDR (In Vitro Diagnostics Regulations) or the MDR (Medical Device Regulations).
What Was The Original Reason For The Change In EU MDR?
There’s no denying that technology has altered the development of medical devices in the recent past. Innovative yet effective medicines and solutions arrived at the market, which was considered unprecedented back in the days when the previous guidelines were announced. These products include applications, new Software types, consumer administered ‘lifestyle tests,’ implantable and intense brain stimulation devices.
While it might not fall under the category of the pre-digital concept of medical devices, it still can affect users negatively if manufactured or misused. In the meanwhile, there has been a steady transition in the aging population and the mass population. The need for clearness is imperative in medical device technical info to dodge misuse and accident.
Due to the impacts of regulations narrowing up with all the loopholes closing in coverage, new device categories will come under the law by the MDR in 2021. Hence, the risk class of particular Invitro Diagnostic devices (IVDs) will be altered and in force by 2022.
It is essential to mention that a rough 80% of all IVD’s will need accreditation by a notified body in the long term. This will be a big jump from the 20% at present. This contributes to bettering the regulatory load for some creators, who were previously poised to undergo an audit. It is undeniable that the IVDs at present will require carving out an auditable QMS to supervise their progression while also achieving their CE marking.
How Do The IVDR and MDR Contribute to Medical Devices?
It is essential to mention that IVDR and the MDR describe the term “medical device” as an “appliance, software, apparatus, implant, another article agent, material,” which can be recycled for any of the following:
- Diagnosis, alleviation or treatment of disease, prevention, monitoring, disability, or injury, but not for injury or disability prevention
- Replacement, Investigation, or alteration of a physiological, anatomical, or extreme process
- Providing information through in-vitro scrutiny of samples collected from the body
Which Products Come Under The MDR?
There’s no denying that the definition already covers a whole host of other pre-existing instruments. However, the EU IVDR regulations identify products that lack CE marking. It covers products that are used to disinfect, clean, or sanitize medical tools. Furthermore, they are utilized to support and control conception through immunological, pharmacological, or metabolic means.
Annex XVI also tells that the below-mentioned groups of products comply with the needs of the MDR to shut loopholes:
- The group of products infused into the physique surgically to effectively alter the anatomy, such as silicone breast implants
- Contact lenses and other optical items such as cosmetic contact lenses or eye drops
- Substances that are used for a facemask as well as other internal fillings such as Botox Injections
- High-intensity emission gear utilized for hair and tattoo removal
- The gear utilized for lipolysis, liposuction, or lipoplasty
- Gear using magnetic or electrical waves to accelerate the brain
What Are The Impacts Of The LVDs?
It is essential to mention that the IVDR has brought the latest innovative cataloging regulations established on the Global Harmonization Task Force System that employs 4-risk based classes – Low (Class A) to High risk (Classes B, C, and D).
The IVDR will help classify the IVDs as per the risk levels- starting from classes B to C and D. Furthermore, they require the participation of Notified Bodies, i.e., independent certification bodies, instead of simple self-assessment. Additionally, all the applications and Software that have been part of the IVD equipment will gain classified status as Software as a Medical Devices (SaMD). They will be eventually integrated into the definition of IVDs and regulated.
How About Other Significant Changes?
One must also not miss out that the fresh MDR boosts a need to integrate a Unique Device Identification (UDI). This will enable them to track all medical devices that have been sold in the EU efficiently. There’s no doubting that the devices will need to be marked with a DI (device identifier). Additionally, every production or batch series should be marked using a PI (production identifier).
Looking forward, both the IVDR and MDR have introduced new and innovative databases for product registration, clinical investigations, and post-market surveillance. In the long term, the EUDAMED database will have access to several databases that permit medical device companies, notified authorities, consumers, regulators, and others for the latest medical device sales in Europe.
A New Challenge and a Unique Opportunity
It is vital to mention that the performance and safety reporting comes with frequency and new pace. They will essentially need considerable resources from external sources for companies. However, if you can keep off the edges of risk-based thinking, you could leverage your SOP’s to identify potential issues better than too quickly in the manufacturing cycle. There’s no doubting that treating them can effectively offer protection to numerous patients while also reducing the manufacturer liability.
Furthermore, the latest MDR and EU IVDR regulations have caused anxiety and uneasiness within the European medical industry. This is primarily due to the improved strain on notified bodies; their incompetence in dealing with the multiple inspections and quarries they are supposed to handle. There has been a massive uproar in the industry, many asking to push the deadlines for an easy transition. One can only wonder if this is wishful thinking since there are enormous legal hurdles present for implementing such a change.
Start Looking at the Future
However, the course of the narrative is taking a different direction. The industry seems to be advising the young developers to complete thorough research to find out the potential ceiling of the device they are working on and its prospect to be in regulatory scope. Furthermore, they must develop a QMS fast to cater to the EU IVDR or Medical Device Reporting demands.
The industry is giving out advices to the existing manufacturers who have well-established devices in the market. As per the suggestion, they must resume working with the notified bodies quickly to identify the changes they require. There could be a few cases where you would require recertification for all existing devices. It would help if you considered auditing your entire portfolio to determine the commercial sense of the market.
There’s no denying that both the MDR and European Union IVDR would affect every medical equipment manufacturer in more than one way. Please use this transitional phase to consult with trade organizations, notified bodies, and consultants for support and advice. This will effectively ensure your committed compliance with the EU on the implementation of new medical device regulations.
