Module 17 2024

05/12/2024

Essential Requirements The Essential Requirements will also be updated to include and specify that devices must be designed and manufactured in a way that reduces, as far as possible, the risks posed to public health by substances or particles that may be released from the device including wear debris, degradation of products and processing residues. The original consultation document also included requirements for Environmental and public health impact assessments and introduced waste management responsibilities into the medical device supply chain. Neither of these proposals is being progressed at this time primarily due to capacity and infrastructure concerns, although these areas will remain under review, and future possible consultations may occur. Chapter 13 - Environmental Sustainability and Public Health Impacts

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Chapter 14: Alternative Routes to Market

MDSAP and Domestic Assurance The regulations propose to utilize both MDSAP certificates and Domestic Assurance as alternative routes to the UK market. The MHRA will require UK Approved Bodies to consider MDSAP assessments; however, adoption will be optional for manufacturers It is expected that the UK Approved Bodies will also be AOs (Auditing Organizations) under the MDSAP scheme, and in most cases, this should be a seamless process. However, there will be some AOs who do not have an affiliation to a UK Approved Body. In such cases the manufacturer would need to appoint a UK Approved Body who would need to review outputs from the AO’s MDSAP audit and review device technical documentation prior to issuing their own UKCA certification.

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