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Our outstanding surgical face masks regulatory lawyers will advise and assist your company if you manufacture or intend to manufacture and/or supply surgical face masks or surgical gloves in the UK.
Unless your company is exempted from the regulations in order to make and supply surgical (medical) face masks or surgical gloves in the UK, intended to protect patients, the face masks must meet the design and safety requirements of the regulations and be CE marked.
In order to assist your company with an application, a regulatory lawyer will require a clinical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of your product in order to assist with the application. The data needs to adequately demonstrate that the product fulfills its intended purpose.
There are further regulatory requirements if the surgical masks are sterile.
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Application for regulatory approval |
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Classification |
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Covid19 Exemption |
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Claims |
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Conformity |
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CE Marking |
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Requirements for Labelling and Packaging |
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Vigilance |
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Articles
Intellectual Property: Design and Trade Mark Law changes- no deal Brexit Guidance, April 2019
Placing manufactured goods on the EU and UK internal markets-no deal Brexit guidance, March 2019
Food Safety: Guidance on Food Traceability, Withdrawals and Recalls within the UK Food Industry, March 2019​
MHRA submissions if NO DEAL BREXIT guidance: Making submissions to the MHRA in a no deal scenario, March 2019
Generic Medicines: Data Exclusivity, May 2013
Pharmaceutical Advertising on the Internet, June 2011
Advertising Pharmaceutical Products, December 2009
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