In Medical Plastics News European Edition, Rowin Vos, General Manager BV at Connect 2 Cleanrooms explores the clean manufacturing guidelines, trends and emerging technologies to provide clarity to manufacturers and takes part in a Q&A.
Europe’s current Medical Device Directive (MDD, 90/385/EEC) on active implantable medical devices states that; “devices must be designed and manufactured in such a way that, when implanted under the conditions and for the purposes laid down, their use does not compromise the clinical condition or the safety of patients.”
The clear message here is on patient safety; however medical device manufacturers often struggle with the fact that the directive is not prescriptive enough in terms of the environment. Instead, some feel it leaves ambiguity over which clean manufacturing standard is applicable to their production environment specification and which guideline they should follow to mitigate risk.
Read the full article in Medical Plastics News - European Edition (Jan - Feb 2020)