UK: Extension of CE recognition & Registration of extended Certificates

The UK government announced that it intends to prolong the acceptance of CE marked medical devices on the Great Britain market!

In Spring 2023, a legislation has been put forward to extend the transitional period from its current deadline (30 June 2023) to the following:

• 30 June 2028 or the expiry of certificate for general devices compliant with EU MDD or EU AIMDD with a valid declaration and CE mark;
• 30 June 2030 or the expiry of certificate for in vitro diagnostic medical devices (IVDs) compliant with the IVD Directive (IVDD);
• 30 June 2030 or the expiry of certificate for devices compliant with the EU’s current Medical Devices Regulation (MDR) and In Vitro Diagnostic medical devices Regulation (IVDR);

In the EU, the validity of CE Certificates has been extended until the following dates, provided they meet the extra requirements under the amendment of 20 March:

• 31 December 2027 for Class III and IIb implantable devices (except well-established technology devices). Procedure packs and systems that contain the devices above are also included.
• 31 December 2028 for Class IIb devices not covered previously and Class IIa, Class Im, Class Is and Class Ir devices.

In the UK, these extended CE Certificates are also valid for placing legacy devices on the market of Northern Ireland and Great Britain.

Table 1: MHRA

It is important to note that Custom-made devices under EU MDD or EU AIMDD can no longer be placed on the GB market.

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The UK government also announced that the future regime for medical devices will apply from 1 July 2025. As of that date, it will not be possible to rely on EU MDR or EU IVDR CE certificates that are renewed after the future regime fully applies.

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MHRA Guidance

The UK’s Medicines & Healthcare products Regulatory Agency has issued a new guidance on registration of certain medical devices in light of the EU extension of the transitional period for legacy devices.

The manufacturers should update the MHRA Device Registration system (DORS) in case they rely on this extension. The only exception are devices that are being up-classified by the EU MDR and are already registered in DORS. Until the dates in the Table 1 above, no further action is required in the MHRA registration system.

In the case of previously expired certificates that were valid on 26 May 2021 but expired before 20 March 2023, MHRA requires from manufacturers to upload a letter declaring that key conditions for the extension of the certificate have been met:

• That the manufacturer has signed a contract with the notified body that pre-dates the original expiry of the certificate OR
• If the above is not fulfilled, confirmation that the manufacturer had been granted a derogation from the conformity assessment procedures under Article 59 EU MDR or Article 97 EU MDR.

In the case of valid certificates that have expired/will expire on or after 20 March 2023 , MHRA asks to upload a letter (option C) declaring that the certificate remains valid under EU MDR Article 120.

The MHRA provides guidance on the appropriate procedure to register medical devices under the following scenarios:

1. CE Certificate expired prior to 20 March 2023, and devices already registered with MHRA;
2. CE Certificate expired prior to 20 March 2023, and devices not yet registered with MHRA;
3. CE Certificate due to expire on or after 20 March 2023 and devices already registered with MHRA;
4. CE Certificate due to expire on or after 20 March 2023 and devices not yet registered with MHRA;
5. EU MDD Class I up classified medical devices under MDR and Class I reusable surgical instruments under MDR already registered with MHRA and with a self-declaration under EU MDD;
6. EU MDD Class I up classified medical devices under MDR and Class I reusable surgical instruments under MDR not yet registered with MHRA and with a self-declaration under EU MDD;

You can find all UK relevant documents in our Library of Documents.