Lesson 4.4 · 5 min
The implant register from 1 September 2027
Open in the coursewith narrated slides, a checklist to tick off and a quiz
At a glance
- Dental implants too. Since 1 September 2026 the implant register covers all implantable medical devices of classes IIb and III, not just a list.
- 1 September 2027. For implants not covered before, it applies to implants placed after 31 August 2027.
- Product and patient. UDI or type and serial number, manufacturer, distributor, plus name and social security number, date, the person responsible and check-up intervals.
- 30 years. The practice that places the implant records this and keeps it for 30 years after implantation.
- With the patient information. The data also go into the information the patient receives with the implant.
In detail
What has changed
Until 31 August 2026 an implant register was only required for the products listed in Annex 5: active implants, joint, soft-tissue and organ implants, and implants in the central circulatory system (MPBV as it stood before Federal Law Gazette II No. 259/2026). Dental implants weren't on the list.
Since 1 September 2026 the register is required for all implantable medical devices of class IIb and III, except the products under Art. 18(3) of the EU Medical Devices Regulation § 10(1) MPBV. That list of exceptions includes sutures, staples, dental fillings, dental braces, tooth crowns, screws, plates and wires. Dental implants are generally class IIb; what counts is the class the manufacturer states.
From when
For products that didn't need a register under the old version, none has to be kept if they are implanted by 31 August 2027 at the latest. In all other cases the register must be set up by the end of that day § 12(10) MPBV. So for a dental implant placed on 1 September 2027 or later, the register applies in any case.
What goes in
| About the product | After implantation |
|---|---|
| UDI where there is one, or name, kind, type, lot or serial number | name and social security number |
| manufacturer's name, address and contact | date of implantation |
| distributor's name, address and contact | name of the person responsible |
| intervals for check-ups, following the manufacturer's information | |
| how long it stays in the body, according to the manufacturer |
Basis: § 10(3), (3a) MPBV. The register must allow product and patient to be identified quickly, for instance in a recall § 10(2) MPBV. Any medium is allowed, paper included § 10(6) MPBV.
Keeping and passing on
The facility responsible for the implantation records the data and keeps them for 30 years after implantation § 10(4) MPBV. It adds them to the patient information under § 50(2) of the Medical Devices Act 2021 § 10(5) MPBV.
Thirty years is longer than the ten years for treatment records (lesson 2.4). When handing over the practice, agree who keeps the register for that long.
Checklist
- We know which of our implants are class IIb or III.
- From 1 September 2027 we enter every implant we place in the register.
- The register holds UDI, manufacturer, distributor, patient, date, person responsible and check-up intervals.
- The data go to the patient with the patient information.
- The register stays available for 30 years, even after the practice is handed over.
Quiz
From when must a dental implant (class IIb) be in the implant register in any case?
- When it is placed on 1 September 2027 or later
- Since 2007
- From 1 January 2028
- Never, dental implants are exempt
Show the answer
The answer is A: When it is placed on 1 September 2027 or later. For class IIb and III implants not covered before, no register is needed if they are implanted by 31 August 2027 at the latest; otherwise it must be set up by then (§ 12(10) MPBV).
Sources
This lesson's statements rest on:
- Medical Device Operators Regulation (Medizinproduktebetreiberverordnung, MPBV) § 10, Federal Legal Information System (RIS), in German, version of 7 October 2026
- Medical Device Operators Regulation (Medizinproduktebetreiberverordnung, MPBV) § 12, Federal Legal Information System (RIS), in German, version of 7 October 2026
- Medical Device Operators Regulation (Medizinproduktebetreiberverordnung, MPBV) § 13, Federal Legal Information System (RIS), in German, version of 7 October 2026
Not legal advice. What counts is the acts and regulations in the Federal Legal Information System and the Austrian Dental Chamber's regulations (read on 7 October 2026). The health minister's regulation with the criteria from 2028 (§ 9b(2) GQG) had not been issued on that day. Not covered are insurer contracts, billing, data protection in detail and the employer's duties under the Worker Protection Act in detail; there is a separate course on those at aschg.globalapps.top. Not an offer of the Austrian Dental Chamber, a regional dental chamber, the BIQG or the Chamber of Commerce.