England

1. Authorities

The Medicines & Healthcare products Regulatory Agency (MHRA) is responsible for regulating medical devices entering the UK market.

UKCA is short for UK Conformity Assessment. On February 2, 2019, the UK government announced the UKCA marking scheme that will be adopted in the event of a no-deal Brexit. This means that after Brexit, EU laws and regulations will no longer apply to the UK. The UKCA mark is a new UK product mark that will be used for medical devices placed on the Great Britain market after the transition period. The UKCA mark will not be recognized in the EU, EEA or Northern Ireland markets.

2. Relevant Regulations

From January 1, 2021, the conversion of MDD, IVDD and AIMDD in UK law (UK Medical Devices Regulations 2002) will continue to apply. The UK Parliament is reviewing the Medicines and Medical Devices Bill 2019-2021. Before this bill is officially launched, the regulations for medical devices in the UK market after January 1, 2021 will still be UK MDR 2002. UK MDR 2002 is legislated based on the three major EU medical device directives, namely:

The EU Medical Devices Regulation (MDR) and the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) will become fully applicable in EU Member States on 26 May 2021 and 26 May 2022 respectively. As these regulations do not come into force until after the end of the transition period with the EU, they will not automatically become EU law retained by the EU Withdrawal Agreement Act and therefore will not automatically apply in the UK.

The UKCA marking requirements for medical devices are based on the requirements of the three original European Medical Device Directives (EU AIMDD, EU MDD, EU IVDD), and have been revised in conjunction with the UK Medical Device Regulations UK MDR 2002 to make them applicable to the UK. The full name of the existing UK Medical Device Regulations is The Medical Devices Regulations 2002 (abbreviated as UK MDR 2002).

The class of a medical device determines the conformity assessment procedure that applies to that device (all active implantable medical devices and their accessories fall into the highest risk class (Class III)). Therefore, the greater the risk posed by the product, the higher the risk classification and the greater the involvement of the Notified Body required. However, all medical devices must have a technical file in order to receive the UKCA mark and be sold on the UK market. Device manufacturers also need to work with the UK Responsible Person to handle product registration.

Active Implantable Medical Devices Directive 90/385/EEC (EU AIMDD)

Medical Device Directive 93/42/EEC (EU MDD)

In vitro diagnostic medical devices directive 98/79/EC (EU IVDD)

3. Time estimation

For low-risk products applying for Class I & General IVDs, the average review time is 2-4 weeks, and the longest review period can be up to 90 days.

Products that require Approval Body review need to be determined based on the specific review time of different AB.

4. Local Representatives

As the UK has left the EU, the regulations for local representatives will be determined according to the transitional regulations. If the manufacturer is located outside the UK, a UK Authorized Representative (UKRP) must be appointed. For non-UK manufacturers, all products with UKCA or CE marking must comply with this requirement.

After the transition period, it is necessary to completely switch to the UKRP UK Authorized Representative logo and no longer use the CE logo.

5. Successful Cases

more than 10+ customers for hundreds of products