Guidance

Registration of certain in vitro diagnostic devices

Published 17 February 2025

The EU has extended the validity of certain Directive 98/79/EC on in vitro diagnostic (IVD) devices (EU IVDD) certificates and declarations. This guidance sets out what this means for registration and managing registered devices in the MHRA Device Online Registration System (DORS).  

EU IVDD CE certificates and declarations of conformity that have been extended under the revised EU IVDR transitional arrangements

The EU has revised the timelines for IVD devices to comply with the EU In vitro Diagnostic Devices Regulation (2017/746) (EU IVDR). The EU will now be accepting devices with EU IVDD certificates on the EU market for longer.  

The EU IVDR transitional arrangements have been amended to extend the validity of EU IVDD CE certificates and declarations of conformity, subject to meeting certain conditions. Previously, certificates would remain valid until the end of the period indicated on the certificate and any remaining certificates would become void on 26 May 2025.

The validity of CE certificates issued from 25 May 2017 and were still valid on 26 May 2022 has been extended, to: 

• 31 December 2027 for Annex II List A, Annex II List B, and Self-test devices

The validity of declarations of conformity was drawn up prior to 26 May 2022 has been extended, to

• 31 December 2027 for General IVD devices that have been upclassified to Class D IVD devices
• 31 December 2028 for General IVD devices that have been upclassified to Class C IVD devices
• 31 December 2029 for General IVD devices that have been upclassified to Class B IVD devices and for class A devices placed on the market in sterile condition

The EU IVDR also provides that certain conditions must be met for the new extension provisions to apply under Article 110(3c).

Please note that notified bodies are not required to change the date on the individual certificates. See the EU’s revisions (Regulation - EU - 2024/1860 - EN - EUR-Lex (europa.eu)) for more details. Please see separate guidance regarding the extension that applies to EU MDD certificates.

Reliance on extended certificates in Great Britain (GB)

CE certificates with extended validity under the extended EU IVDR transitional arrangements (Article 110) are valid for placing devices on the GB market for the period in which EU IVDD CE marked medical devices are accepted on those markets.

We have put in place legislation to extend acceptance of CE marked IVD devices on the GB market to support ongoing safe supply of medical devices to GB and ease the transition to the future regulatory framework for IVD devices.  

We have introduced measures which provide that CE marked IVD devices compliant with the EU IVDD OR EU IVDR can be placed on the GB market up until the sooner of expiry of certificate or 30 June 2030.

This enables certain CE marked IVD devices to continue to be placed on the GB market for longer. General IVD devices under the Directives for which the conformity assessment under the EU IVDD did not require a notified body, can only be placed on the GB market if the involvement of a notified body would be required under the EU IVDR (that is, if it is an upclassified device).

If placing IVD devices on the GB market under these transitional measures, manufacturers will not be able to rely on expired certificates (unless such certificates have been otherwise deemed valid by the EU).

This means devices with valid EU IVDD certificates can be placed on the GB market up until the expiry of the certificate or 30 June 2030, whichever is sooner (see the table in Annex A).

If you have an EU IVDD CE certificate with its validity extended under Article 110 of the EU IVDR that you wish to rely on for placing devices on the GB market, MHRA encourages you to update the MHRA Device Online Registration System as set out in this guidance below. 

We have also put in place strengthened post-market surveillance (PMS) requirements for GB.  

Reliance on extended certificates in Northern Ireland (NI)

The rules for placing IVD devices on the NI market differ from those applicable to GB. The EU IVDR has applied in EU Member States and in NI since 26 May 2022. Further guidance can be found here.

CE certificates with extended validity under the extended EU IVDR transitional arrangements (Article 110) are valid for placing devices on the NI market while EU IVDD CE marked medical devices are accepted on those markets.

This means provided that the conditions for placing a device on the EU market set out in Article 110(3c) are met, they are valid for placing a IVD device on the NI market up until the end of the relevant transition period set out in Article 110(3a and 3b) (see the table in Annex A), namely:  

• those devices continue to comply with Directive 98/79/EC
• there are no significant changes in the design and intended purpose
• the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health
• In addition, you will need to take the steps below:
  • by 26 May 2025, you will need to provide evidence that you have put in place a quality management system in accordance with EU IVDR Article 10(8)
  • by 26 May 2025 you will need to provide evidence that you or your authorised representative have lodged a formal application with a notified body
  • by 26 September 2025, you will need to provide evidence that the notified body and the manufacturer have signed a written agreement.

If you have an EU IVDD CE certificate with its validity extended under Article 110 of the EU IVDR that you wish to rely on for placing devices on the NI market, the MHRA encourages you to update the MHRA Device Online Registration System as set out in this guidance below.    

Previously expired certificates 

If you wish to rely on a previously expired certificate (that was still valid on 26 May 2022 and expired before 9 July 2024), upload a letter issued by the notified body stating the receipt of the manufacturer’s application for conformity assessment and the conclusion of a written agreement. Alternatively, instead of a letter issued by a notified body, you may complete and upload the template declaring that key conditions for extension of the certificate (under EU IVDR Article 110) have been met, namely:  

• that the manufacturer has a signed contract with the notified body that pre-dates the original expiry of the certificate, or
• if no such contract was signed at date of expiry, then confirmation that the manufacturer had been granted a derogation from the conformity assessment procedures under Article 54(1) of EU IVDR or that they had been given a period of time to carry out conformity assessment in accordance with Article 92(1) of EU IVDR

Scenario 1: CE certificate expired prior to 9 July 2024 – device/s already registered with the MHRA   

If the IVD device that you would like to place on the market reliant on an expired EU IVDD CE certificate with validity extended under EU IVDR is already registered with MHRA, complete the following steps to make this declaration.   

Access your account on the MHRA Device Online Registration System (DORS) and follow the Manage Registered Devices instructions in the Device Registration Reference Guide:  

• unlink the expired CE certificate(s)
• upload the appropriate notified body letter or declaration (see the template) that Article 110 extended CE certificate validity applies (indicating that (a) or (b) above apply)
• select the original CE certificate type from the dropdown options
• select the appropriate expiry date for the reliance on the declaration – the new date the CE certificate is valid until (deadlines depending on device type are in the Annex A table below) - note that if your device is being placed on both the GB and NI market you should upload one letter or declaration for both markets and record as the expiry date the sooner applicable validity date

• enter actual CE certificate number in the reference field and append with ‘_EU IVDR Art110 Extension’ (see example below)

• select the original EU notified body designation – CE- MDD/IVDD/AIMD option
• select the name of the EU notified body currently responsible for the appropriate surveillance in respect of the device(s) concerned (if the notified body is not available in the Device Online Registration system (DORS), email: device.registrations@mhra.gov.uk)
• click ‘Upload certificate’

You cannot update the date on which your certificate has expired. If you have a certificate that has expired entered on the system, you will not be able to order Certificates of Free Sale (CFS) and your registered devices on the Public Access Registration Database (PARD) will be appended with ‘Conformity Assessment Certificate expired’ until you have taken the above action. 

Scenario 2: CE certificate expired prior to 9 July 2024– device/s not yet registered with the MHRA  

If the medical device that you would like to place on the market reliant on an expired EU IVDD CE certificate with validity extended under EU IVDR is not already registered with the MHRA, complete the following steps to make this declaration.  

Access your account on the MHRA Device Online Registration System (DORS) and follow the Add Devices using GMDN instructions in the Device Registration Reference Guide. On the Conformity Assessment Certificate page: 

• upload the expired CE certificate
• select correct certificate type
• enter the appropriate extended CE certificate validity date from Annex A table below in the certificate expiry date field (we recognise this is not the expiry date on the actual certificate)
• enter CE certificate reference number
• select the appropriate EU notified body designation - CE- MDD/IVDD/AIMD option
• select the correct EU notified body name
• click ‘Upload certificate’
• follow steps a-g for any additional CE certificates required for the device, then:
• upload the appropriate notified body letter or declaration (see the template) that Article 110 extended CE certificate validity applies (indicating (a) or (b) above apply)
• select the original CE certificate type from the dropdown options
• select the appropriate validity date for the Device Class per below table (Annex A)
• enter actual CE certificate number in the reference field and append with ‘_EU IVDR Art110 Extension’
• select the original EU notified body designation - CE- MDD/IVDD/AIMD option
• select the name of the EU notified body currently responsible for the appropriate surveillance in respect of the device(s) concerned (if the notified body is not available in the Device Online Registration System (DORS), email device.registrations@mhra.gov.uk)
• click ‘Upload certificate’

Certificates expiring on or after 9 July 2024

If you wish to rely on a certificate that was valid on 26 May 2022 and has expired on or after 9 July 2024, upload a letter issued by the notified body stating the receipt of the manufacturer’s application for conformity assessment and the conclusion of a written agreement. Or instead of a letter issued by a notified body you may upload a declaration that the certificate remains valid under EU IVDR Article 110.  

We have provided a template for this declaration – the above declaration is set out as option c in the template.   

Scenario 3: CE certificate was due to expire on or after 9 July 2024 – device/s already registered with the MHRA  

To do this, access your account on the MHRA Device Online Registration System (DORS) and follow the Manage Registered Devices instructions in the Device Registration Reference Guide to: 

• unlink the expired CE certificate(s)
• upload the appropriate notified body letter or declaration (see the template) Article 110 extended CE certificate validity applies (indicating (c) applies)
• select the original CE certificate type from the dropdown options
• select the appropriate validity date for the Device Class as set out in the Annex A table below - note that if your device is being placed on both the GB and NI market you should upload one letter or declaration for both markets and record as the expiry date the sooner applicable expiry date
• enter actual CE certificate number in the reference field and append with ‘_EU IVDR Art110 Extension’
• select the original EU notified body designation - CE- MDD/IVDD/AIMD option
• select the name of the EU notified body currently responsible for the appropriate surveillance in respect of the device(s) concerned (if the notified body is not available in the Device Online Registration System (DORS), email: device.registrations@mhra.gov.uk)
• click ‘Upload certificate’

You cannot update the date on which your certificate has expired. If you have a certificate that has expired entered on the device registration system, you will not be able to order Certificates of Free Sale (CFS) and your registered devices on the Public Access Registrations Database (PARD) will be appended with ‘Conformity Assessment Certificate expired’ until you have taken the above action. We therefore recommend that you take the above action before the expiry date of your CE certificate/s.                

Scenario 4: CE certificate due to expire on or after 9 July 2024 – not yet registered with the MHRA  

If the medical device that you would like to place on the market is reliant on an expired EU IVDD CE certificate with validity extended under EU IVDR and is not already registered with the MHRA, complete the following steps to register your device/s and make this declaration.  

Access your account on the MHRA Device Online Registration System (DORS) and follow the Add Devices using GMDN instructions in the Device Registration Reference Guide. On the Conformity Assessment Certificate page: 

• upload the expired CE certificate
• select correct certificate type
• enter the appropriate extended CE certificate validity date (from Annex A table below) in the certificate expiry date field (we recognise this is not the expiry date on the actual certificate)
• enter CE certificate reference numbers
• select the appropriate EU notified body designation - CE- MDD/IVDD/AIMD option
• select the correct EU notified body name
• click ‘Upload certificate’
• follow steps a-g for any additional CE certificates required for the device, then:
• upload the appropriate notified body letter or declaration (see the template) that Article 110 extended CE certificate validity applies (indicating (c) applies)
• select the original CE certificate type from the dropdown options
• select the appropriate validity date for the Device Class as set out in the Annex A table - note that if your device is being placed on both the GB and NI market you should upload one letter or declaration for both markets and record as the expiry date the sooner applicable validity date   
• enter actual CE certificate number in the reference field and append with ‘_EU IVDR Art110 Extension’
• select the original EU notified body designation - CE- MDD/IVDD/AIMD option
• select the name of the EU notified body currently responsible for the appropriate surveillance in respect of the device(s) concerned (if the notified body is not available in the Device Online Registration System (DORS), email: device.registrations@mhra.gov.uk)
• click ‘Upload certificate’

Upclassified General IVD devices

EU IVDR Article 110(3b) deals with upclassified General IVD devices (devices for which the conformity assessment procedure pursuant to Directive 98/79/EC did not require the involvement of a notified body, for which the declaration of conformity was drawn up prior to 26 May 2022 and for which the conformity assessment procedure pursuant to EU IVDR requires the involvement of a notified body).  

If you wish to rely on a declaration of conformity under EU IVDD (for an upclassified device under EU IVDR) that was issued before 26 May 2022 to place a device on the NI market, the manufacturer would need to have met the relevant conditions (including the conditions for continued reliance on the aforementioned declaration of conformity (under EU IVDR Article 110(3c)), namely:  

• those devices continue to comply with Directive 98/79/EC
• there are no significant changes in the design and intended purpose
• the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health

In addition, you will need to take the steps below: 

• by 26 May 2025, you will need to provide evidence that you have put in place a quality management system in accordance with EU IVDR Article 10(8)
• you will need to provide evidence that you or your authorised representative have lodged a formal application with a notified body by:
  • 26 May 2025 for General IVD devices that have been upclassified to Class D
  • 26 May 2026 for General IVD devices that have been upclassified to Class C
  • 26 May 2027 for General IVD devices that have been upclassified to Class B
• you will need to provide evidence that the notified body and the manufacturer have signed a written agreement by:
  • 26 September 2025 for General IVD devices that have been upclassified to Class D
  • 26 September 2026 for General IVD devices that have been upclassified to Class C
  • 26 September 2027 for General IVD devices that have been upclassified to Class B

Scenario 5: EU IVDD General IVD devices that have been upclassified under EU IVDR and require notified body involvement pursuant to EU IVDR – devices already registered with the MHRA with a self-declaration under EU IVDD   

Until the dates set out in the table in Annex A, no further action is required in the registration system at this time to maintain reliance on your self-declaration under EU IVDD for a device which is General IVD device under EU IVDD that is upclassified under EU IVDR, and will require notified body involvement in its assessment. Sign up to receive updates via the MHRA registration guidance page for updates on any future registration requirements related to upclassified medical devices. 

Scenario 6: EU IVDD General IVD devices that have been upclassified under EU IVDR and require notified body involvement pursuant to EU IVDR – device/s not yet registered with the MHRA  

You can register a device with the MHRA which is a non-sterile, General IVD device under EU IVDD that is upclassified under EU IVDR with an EU IVDD self-declaration until the dates set out in the table in Annex A.  

To register your device with the MHRA in this scenario, access your account on the MHRA Device Online Registration System (DORS) and follow the instructions to Add Devices using GMDN in the Device Registration Reference Guide.      

Annex A: extended validity dates  

IVD Device class	NI market	GB market
Annex II List A, Annex II List B, Self-tests	The extended certificate end date under EU IVDR will be valid until 31 December 2027	The extended certificate end date under EU IVDR will be valid until 31 December 2027
Upclassified General IVD devices to Class D (that newly require involvement of a notified body under EU IVDR)	The EU IVDD Declaration of Conformity will be valid until 31 December 2027	The EU IVDD Declaration of Conformity will be valid until 31 December 2027
Upclassified General IVD devices to Class C (that newly require involvement of a notified body under EU IVDR)	The EU IVDD Declaration of Conformity will be valid until 31 December 2028	The EU IVDD Declaration of Conformity will be valid until 31 December 2028
Upclassified General IVD devices to Class B (that newly require involvement of a notified body under EU IVDR)	The EU IVDD Declaration of Conformity will be valid until 31 December 2029	The EU IVDD Declaration of Conformity will be valid until 31 December 2029

The above dates are subject to any relevant conditions under EU IVDR Article 110(3c) being met. Note that if your device is being placed on both the GB and NI markets you should upload one declaration that Article 110 extended CE certificate validity applies for placement on both the GB and NI markets combined.