The recent BSIF webinar on the UKCA Mark and what it means for the PPE industry was very well attended and yielded a lot of questions. BSIF have now provided answers to those questions, please see below, all questions are answered based upon current understanding and may be subject to change. Some questions have been edited for clarity purposes only:
| Question | Answer | |
| What is the official reference for UKCA / NI PPE documentation? | For GB Market ‘Regulation 2016/425 on Personal Protective Equipment as brought into UK law and amended’ For NI Market ‘Regulation EU 2016/425 on Personal Protective Equipment’ | |
| What does the UK see as a medical device? Does this contain orthopaedic insoles, semi-orthopaedic insoles, knee braces, etc.? | Medical Devices Directive 93/442/EEC provides detail as to what a medical device is | |
| Will dual marking apply to a device that fits the definition of being both a medical device as well as PPE? | Yes – timescales will differ as previously mentioned | |
| Can this presentation be duplicated for medical devices because the format and examples are really easy to understand? | This is outside of our remit unfrotunately. |