Regulation (EU) 2017/746 on in-vitro diagnostics (the IVDR) has been in effect since 26 May 2022, replacing Directive 98/79/EC on in-vitro diagnostics (the IVDD). As of this date, in-vitro diagnostics are required to comply with the IVDR. For a large number of in-vitro diagnostics, this means the inclusion of a notified body in the conformity assessment procedure (link to the January newsletter: “Grace Period for IVDR Compliance”). Given the small number of notified bodies which have been accredited in accordance with the IVDR, the inclusion of notified bodies poses a challenge for manufacturers of in-vitro diagnostics. This circumstance has been understood by European lawmakers after hearing clear messages from the industry, and manufacturers of in-vitro diagnostics whose conformity assessment procedures are to include a notified body in accordance with the IVDR have been granted extended transitional periods for compliance with the IVDR.
Transitional periods for compliance with the IVDR based on the risk class of the in-vitro diagnostics
The length of these transitional periods depends on the risk class of the in-vitro diagnostics. Manufacturers of in-vitro diagnostics can only benefit from these transitional periods if their products meet the specifications of the IVDD and if no significant changes are made after 26 May 2022 to the device itself or to its intended purpose.
Expiration of the transitional periods will mean that in-vitro diagnostics will be required to comply in full with the IVDR as of the following dates:
- For Class A in-vitro diagnostics (non-sterile) and in-vitro diagnostics of all classes whose declaration of conformity is issued after 26 May 2022, the effective date for compliance with the IVDR is 26 May 2022.
- For Class D in-vitro diagnostics, the effective date for compliance with the IVDR is 26 May 2025, provided their declaration of conformity was issued prior to 26 May 2022.
- For Class C in-vitro diagnostics, the effective date for compliance with the IVDR is 26 May 2026, provided their declaration of conformity was issued prior to 26 May 2022.
- For Class B and Class A (sterile) in-vitro diagnostics, the effective date for compliance with the IVDR is 26 May 2027, provided their declaration of conformity was issued prior to 26 May 2022.
In-vitro diagnostics which are placed on the market prior to their effective date for compliance with the IVDR may be made available on the market for one additional year after the passage of their effective date (the “sell-off rule”), with “making available on the market” defined as any supply of a device for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge. This means e.g. that devices which are placed on the market, i.e. which were made available in the Union market for the first time, prior to the device’s effective date for compliance with the IVDR may continue to be sold for one additional year after the effective date specified.
Manufacturers of in-vitro diagnostics which are placed on the market after their effective date for compliance with the IVDR are required to ensure that their devices meet the requirements of the IVDR. Otherwise, manufacturers face the threat of measures by the market surveillance authorities, which may include orders prohibiting them from making their devices available on the market, as well as recall or withdrawal orders. For manufacturers of Class A (non-sterile) in-vitro diagnostics and in-vitro diagnostics of all classes whose declaration of conformity is issued after 26 May 2022, market surveillance measures may be adopted right now.
The transitional periods do not affect all requirements for manufacturers
Some provisions of the IVDR take effect on 26 May 2022 for all in-vitro diagnostics, regardless of risk class. From that date forward, manufacturers will be required to adhere to the following provisions of the IVDR:
- the requirements for post-market surveillance of their devices through implementation of a surveillance system and reporting on the surveillance and safety of their devices;
- the requirements concerning vigilance with regard to serious incidents and field safety corrective actions;
- the requirements for registration of economic operators and devices in Eudamed.
In this case as well, violators face the threat of severe measures by the market surveillance authorities, including possible recall or withdrawal orders.
If they have not already done so, manufacturers should immediately comply with the IVDR’s requirements for the registration of devices and of the manufacturers themselves, as well as those relating to post-market surveillance of their devices and vigilance requirements, in order to avoid measures by the market surveillance authorities.
Regardless of the risk class of their devices, manufacturers are advised to implement the IDVR’s requirements in a timely manner and in particular to expedite the conformity assessment procedure with involvement of the notified body. This procedure may take a considerable amount of time given the small number of accredited notified bodies, and manufacturers should take this into account in planning for the date on which they will be required to comply in full with the IVDR.back