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Our MDR Medical Device Checker assesses the likelihood of your product falling within the scope of the Medical Devices Regulation (MDR), due to become fully applicable in the EU/EEA on 26 May 2021.
Through a straightforward series of questions, the Medical Device Checker helps with your initial assessment of whether the MDR applies to your product. It is not intended to replace legal advice, which you should seek in any event to confirm the assessment.
The MDR is not just about medical devices and their accessories. It also regulates certain products without an intended medical purpose that are similar to medical devices in terms of their function and risk profile.
The MDR will not only regulate more products than are currently caught by the regulatory framework for medical devices; it will also impose stricter compliance requirements. If you're developing a product in the medtech space, you should establish as early as possible, whether it is regulated by the MDR.
Launched by our Life Sciences & Healthcare team's regulatory experts, our MDR Medical Device Checker is designed for companies developing technologies which might be considered or regulated as medical devices – the tech and pharma companies entering the medtech space and medtech start-ups – and their funders.
You can use the MDR Medical Device Checker in the initial phase of developing your product launch strategy, to support your own assessment of whether the MDR might apply to your product and/or demonstrate to investors that you have given consideration to compliance. Please note, however, that this tool does not replace appropriate regulatory due diligence.
If used correctly, our MDR Medical Device Checker will help you to avoid unpleasant surprises; compliance with the MDR is associated with significant organisational and financial expenditure. It will allow you to take this into account earlier in your product development journey, and ahead of instructing a regulatory expert who can make a final determination.
The MDR Medical Device Checker will also help you reduce the risk of committing a criminal offence of placing a medical device on the market without a valid CE mark.
The MDR Medical Device Checker will ask you a series of questions. When you complete them, you will receive a report based on the answers you have given which sets out whether your product is likely to fall within any of the types of products regulated by the MDR.
For best results:
If at any point you feel that the right answer is "maybe" or that none of the options offered neatly fit your product, it may be because your product is complicated, or borderline. In that case, please note the question number and contact us.
The MDR Medical Device Checker is provided for general information only. It does not constitute legal or professional advice, and should not be relied on as such advice or as a substitute for such advice, in any circumstance. You should obtain professional legal advice before taking, or refraining from, any action on the basis of the MDR Medical Device Checker.
Taylor Wessing (which includes all Taylor Wessing firms) makes no representations, warranties or guarantees, whether express or implied, that the MDR Medical Device Checker is accurate, complete or up to date and accepts no responsibility or liability to any person in respect of anything done or not done in reliance, whether sole or partial, upon its content. Taylor Wessing does not intend that the MDR Medical Device Checker, or the outcomes generated should be relied upon by any party as advice on their specific risk profile, or advice on what products are regulated by Regulation (EU) 2017/745 or any other legislation. Taylor Wessing accepts no liability of any nature towards any party which claims to have placed reliance on the MDR Medical Device Checker or its contents.
We may include links to third-party websites, plug-ins and applications. Clicking on those links or enabling those connections may allow third parties to collect, process, and share data about you. We do not control these third-party websites and are not responsible for them. We encourage you to read the privacy notice of every website you visit.
All information you provide in the MDR Medical Device Checker will be held in a secure environment and we ensure that your confidential information is protected.
Tasmina Goraya, PhD