Medical Devices

Prestige Compliance Regulatory Consultants in Nottingham use Knowledge, Expertise, and Experience, which enables us to offer Comprehensive Compliance Solutions that incorporate all your requirements. We provide Professional Regulatory Affairs Consultancy Services for Manufacturers, Suppliers, and Distributors.

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What are Medical Devices?

Medical Devices are any Device intended to be used for Medical Purposes. Significant potential for Hazards is inherent when using a Device for Medical Purposes therefore Medical Devices must be proved Safe and Effective with reasonable assurance before Regulating Governments allow Marketing of the Device in their Geographical Region.

Compliance is critical in the Medical Device arena to ensure Safety of consumers. As a rule, as the associated risk of the Device increases the amount of testing required to establish Safety and Efficacy also increases. Furthermore, as Associated Risk increases the Potential Benefit to the patient must also increase.



Law in the European Union and Great Britain  

Regulation (EU) 2017/745 is a Regulation of the European Union on the Clinical Investigation and Sale of Medical Devices for Human use.  The In-Vitro Diagnostic Devices Regulation (Regulation (EU) 2017/746) introduces a new classification system for Companion Diagnostics and the obligation to undergo a Conformity Assessment by a Notified Body. In Great Britain (England, Wales and Scotland), Devices must conform to the UK MDR 2002, the EU MDR (until 30 June 2023), or the EU IVDR (until 30 June 2023) in order to be Registered and Marketed. These Regulations are enforced by the Medicines and Healthcare products Regulatory Agency (HMRA) in the UK and the European Medicines Agency) EMA in the European Union.


Law in the USA and Canada  

In the United States of America, the Food and Drug Administration (FDA) Regulates permanent and single-use Medical Devices through the Federal Food, Drug and Cosmetic Act (FD&C Act). Devices are classified into Class I, II, and III with Regulatory control increasing from Class I to Class III. Most Class I Devices are exempt from Premarket Notification 510(k) whilst most Class II Devices require Premarket Notification 510(k), and most Class III Devices require Premarket Approval.




What We Can Do

Prestige Compliance Regulatory Consultants in Nottingham provide Regulatory Support and Advice to assist with meeting all Regulatory Requirements, helping you navigate the International Regulatory Landscape. 

Medical Device Regulations, Directives and Guidelines are often very complex. Our Experts provide a thorough regulatory strategy which is fundamental to getting Products on the Market. We help you identify Medical Device Regulations for specific geographical regions to ensure Medical Device Compliance in all your Market Regions as well as expansion to New Markets.

Prestige Compliance support your business needs from Product Innovation through to Market Authorisation.

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Our Experts are here to help you achieve Regulatory Compliance

Contact our Regulatory Consultants in Nottingham to arrange an initial consultation.