A Complete Guide to Medical Device Certification and Compliance in the European Union and the United Kingdom
In the European Union and the United Kingdom, there are specific regulatory and legal perimeters that apply to the manufacturing and distribution of medical devices. We have developed this comprehensive guide to assist manufacturers who are either based in these regions or who plan to sell their medical device products on either of these markets.
In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating medical devices. Since January 2021, there have been a number of changes when it comes to regulating medical products in the UK, and this article is intended to provide an easy-to-follow guide for ensuring your product meets the correct requirements.
KPMG Advisory stated in April 2021: “While the outlook for medical device companies appears positive, unsustainable healthcare costs and new competitive forces threaten to alter the future industry landscape…” The medical device industry is a fast-growing, lucrative industry however, are product manufacturers able to keep up? With many new regulations and evolving legislation for products globally, medical device manufacturers must act now to ensure the viability and longevity of their products into the future.
Medical devices cover a wide range of products – from robot-assisted surgical instruments to a bandage or gauze. The spectrum of medical device classification is wide and it is extremely important to know which classification your product falls under. In the United States, there are both mandatory and voluntary certification procedures when it comes to ensuring compliance with your medical device. We have outlined the key requirements for your business here.