Surgical Face Masks, Surgical Gloves, Standalone Software and Apps

Imagine receiving amazing

quality legal advice and

assistance on your surgical

masks or gloves from

remarkable regulatory

lawyers

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.

Product Types

Gloves with ‘dual use’
Examination Gloves
Examination Gloves coated with an antimicrobial agent
Stand-alone software including apps
Sterile Surgical Gloves
Surgical Gloves
Surgical Gloves coated with an antimicrobial agent
Surgical Masks

Our Services

Application for regulatory approval	Preparation of Application for Regulatory Approval Clinical Evaluation to demonstrate safety and performance Clinical Investigation if there insufficient pre-existing evidence to demonstrate that the product conforms with the essential requirements of the law Preparation of Technical Documentation
Classification	Classification of Products
Covid19 Exemption	Application for exemption due to Covid19
Claims	Substantiation of Claims
Conformity	Declaration of Conformity Conformity Assessment Advice
CE Marking	CE Marking Compliance
Requirements for Labelling and Packaging	Labelling & Packaging Compliance Advice
Vigilance	Vigilance procedures Post-market surveillance, corrective action and vigilance procedure

Articles

REACH: Restrictions imposed on the Use of Phthalates in Plasticised Materials, July 2019
Online Pharmacies: Guidance for Registered Pharmacies providing Pharmacy Services at a Distance including on the Internet, June 2019
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
Regulation of Medical Devices, September 2018
Generic Medicines: Data Exclusivity, May 2013
Pharmaceutical Advertising on the Internet, June 2011
Advertising Pharmaceutical Products, December 2009

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Testimonials

DNA Diagnostics Centre

‘We really appreciated RT Coopers professional expertise regarding a project they assisted with. Detailed and structured feedback was crucial and very important to our innovative concept. I will definitely revert back to Rosanna and the team on other projects in the near future.’ Daniell Leigh, Director

For more testimonials on Product Regulation