Newbie22
Starting to get Involved
Hi everyone ,
I'm new to this forum and the MD industry, and have joined this forum in hope to learn more about this topic.
I have a few questions that I can't find any solid answers to online, specially since the new regulation has not been published yet.. Hence, why I created this new thread.
I was discussing with my friend in regards to existing MDs under the old EU MDD 93/42/EEC that are sold into the GB market. We are both aware that any new MD sold into the GB market under any EU legislation (both MDD and MDR) will only be recognised in the GB until June 30th 2023. Following this date all new MD must comply to the UKCA mark (The Medical Devices Regulations 2002 (SI 2002 No 618, as amended).
1. My first question is what occurs to MD already circulating the GB market after this date? does the legal manufacture/importer have to recall all their devices under the MDD/MDR after June 30th 2023? e.g. if they have not transitioned to the UKCA yet..
2. If the legal manufacture MDD Conformity Assessment Certificate expires in April 2023, can the products (produced before April 2023) still be transferred to the UK importer following the expiration date? (e.g. can provide invoices supporting this) until a new UKCA certification?
If Q2.) is a Yes... Is it even worth having these MD sent to the UK importer? since their Conformity Assessment Certificate has expired? hence, in-compliant?
Thanks
T
I'm new to this forum and the MD industry, and have joined this forum in hope to learn more about this topic.
I have a few questions that I can't find any solid answers to online, specially since the new regulation has not been published yet.. Hence, why I created this new thread.
I was discussing with my friend in regards to existing MDs under the old EU MDD 93/42/EEC that are sold into the GB market. We are both aware that any new MD sold into the GB market under any EU legislation (both MDD and MDR) will only be recognised in the GB until June 30th 2023. Following this date all new MD must comply to the UKCA mark (The Medical Devices Regulations 2002 (SI 2002 No 618, as amended).
1. My first question is what occurs to MD already circulating the GB market after this date? does the legal manufacture/importer have to recall all their devices under the MDD/MDR after June 30th 2023? e.g. if they have not transitioned to the UKCA yet..
2. If the legal manufacture MDD Conformity Assessment Certificate expires in April 2023, can the products (produced before April 2023) still be transferred to the UK importer following the expiration date? (e.g. can provide invoices supporting this) until a new UKCA certification?
If Q2.) is a Yes... Is it even worth having these MD sent to the UK importer? since their Conformity Assessment Certificate has expired? hence, in-compliant?
Thanks
T