Bifogade filer
BBS-Bioactive Bone Substitutes Plc – Insider information: The company updates the status of the CE marking process
Prenumeration
Beskrivning
| Land | Finland |
|---|---|
| Lista | First North Finland |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
BBS-Bioactive Bone Substitutes Plc | Company Release | November 05, 2024 at 19:00:00 EET
Insider information: The company updates the status of the CE marking process
BBS Bioactive Bone Substitutes Oyj ‘s Notified body BSI has become to the conclusion that the provided clinical data is insufficient as required by the new MDR and as a result they will proceed refusal to review the ARTEBONE® application for certification. Notified body has promised to deliver the official refusal document within 2 weeks.
Once the deficiencies have been corrected, the company can submit a new CE marking application according to Notified body. The company wants to emphasise that, during the meeting, no remarks were made regarding the ARTEBONE® implant itself.
At this stage, the company will not provide further information about future plans but will issue additional details in a separate announcement later.
The product's journey towards commercialization (updated)
| Phase | Action | Status |
| Product development | Preclinical animal tests | Completed |
| Functionality and efficiency tests | Completed | |
| Clinical test | Completed | |
| CE marking | Submitting the CE application | Completed |
| Quality system application | Approved | |
| 1st audit | Completed | |
| 2nd audit | Completed | |
| Additional audit | Completed | |
| Additional measures | Completed | |
| Product approval | Suspended | |
| Product classification | Completed | |
| Consultation with the Medicines Agency | Suspended | |
| Production lines and line certification | In process | |
| Commercialization | Preliminary commercialization | In process |
| Extensive commercialization | In preparation |
Previously published announcements related to the CE marking application
- May 5, 2024 – Insider information: The company updates the status of the CE marking process – CE-mark process will not be completed by the end of the second quarter in 2024
- November 25, 2023 – The Notified Body has approved the Company’s quality system
- November 2, 2023 – Insider information: The company provides an update on the CE marking process related to the approval of the quality system – consultation with the Finnish Medicines Agency to begin on 21 November 2023
- September 13, 2023 – Insider information: Plan to complete minor open issues approved – the Company updates its outlook on the schedule of the CE marking
- August 31, 2023 – Inside information: The final report of the additional audit received from the Notified Body
- May 26, 2023 – Inside information – Positive decision received on the product classification, schedule for the quality system approval to be updated
- March 27, 2023 – Inside information: The final report of the second audit received from the Notified Body, the CE marking process may continue and CE marking approval continues to be expected during 2023
- December 30, 2022 – Insider information: BBS updates the estimate of the CE marking approval schedule of ARTEBONE® Paste
- November 18, 2022 – Inside information: The first audit completed by the Notified Body, CE marking process may continue as planned
- March 9, 2022 – BBS Bioactive Bone Substitutes Plc has filed the CE-marking application of Artebone® bone void filler to the authorities