Official Announcement! UK Will Refuse To Recognize CE Mark!

Recently, the official website of the British government officially announced that the transition period of brexit will end at the end of 2020 (from February 1, 2020 to December 31, 2020). From 1 January 2021, the drug and health products Regulatory Authority (MHRA) will assume responsibility for the current UK medical device market through the EU system.

That is to say, the UK will no longer use CE certification and open its own independent MHRA certification.

It is understood that the British medical device regulations will be officially separated from the EU in January 2021. From January 1, 2021, the British drug and Health Products Administration (MHRA) will assume the responsibilities of the UK medical device market which is currently under the responsibility of the EU system.

Recently, the United Kingdom has issued medical device regulations and safety guidelines to make new specifications for medical device audit standards in the United Kingdom, Northern Ireland and the European Union (among them, Northern Ireland will implement different rules from the United Kingdom). After a transitional period, the UK will no longer recognize the CE mark. After that, the manufacturer must affix the UK CA mark. It will replace the CE mark in the UK market.

01

CE certification will be invalid in 2023

From January 1, 2021, many changes will take place in the UK medical device market. These are:

• The CE mark will continue to be used and approved until June 30, 2023

• Certificates issued by designated institutions in the European Economic Area (EEA) will remain valid for the UK market until 30 June 2023

• From 1 January 2021, manufacturers who wish to place their equipment on the UK market will have a new way to market and mark their products.

• From 1 January 2021, all medical devices and in vitro diagnostic medical devices (IVD) launched in the UK will need to be registered in the MHRA. There will be a grace period for registration:

>4 months for class III and IIB implants and all active implantable medical devices

>8 months for other class IIB and all class IIa equipment

>12 months for class I equipment

• The above 12-month grace period is not applicable to class I equipment and general IVD manufacturers currently required to register with MHRA.

• If you are a manufacturer outside the UK and want to put your equipment on the UK market, you need to establish a UK head who is responsible for the product in the UK.

02

New UK regulation on medical devices and in vitro diagnostics Next year

Currently, equipment in the UK is regulated by the following regulations:

• Directive 90 / 385 / EEC (EU aimdd) on active implantable medical devices

• Directive 93 / 42 / EEC on medical devices (EU MDD)

• Directive 98 / 79 / EC (EU IVDD) on in vitro diagnostic medical devices

These directives have entered into force in UK law through the medical devices Regulation 2002 (Si 2002 no 618, as amended (UK MDR 2002). These Regulations (in the form of 1 January 2021) will continue to be in force in the UK after the transitional period.

Since January 1, 2021, EU medical device regulation (MDR) and European Union in vitro diagnostic medical device regulation (ivdr)

MDR and ivdr will be fully applied in EU Member States on 26 may 2021 and 26 may 2022 respectively. As these provisions do not come into force until after the end of the transition period with the EU, they will not become EU laws automatically retained by the EU withdrawal agreement act and therefore will not be automatically applied in the UK.

03

Domestic equipment listed in UK must be registered by MHRA

The longest transition period is 12 months!

From January 1, 2021, any medical device, IVD or custom device will need to be registered with MHRA before it can be put into the UK market.

MHRA will only register on equipment where the manufacturer has a place of business in the UK. If the manufacturer is located outside the UK, the UK head with a registered place of business in the UK needs to be specified. The UK head will then be responsible for the manufacturer's responsibility in registering the device with the MHRA.

As this is an extension of the existing registration requirements, there will be a grace period to allow time to comply with the new registration process.

There will be 4 months to register with MHRA (until April 30, 2021) for the following devices:

• Active implantable medical equipment

• Class III medical equipment

• Class IIB implantable medical devices

• IVD checklist a

There will be 8 months to register with MHRA (until August 31, 2021) for the following devices:

• Class IIB non implantable medical devices

• Class IIa medical equipment

• IVD List B

• Self test IVD

For the following devices, there will be 12 months to register with MHRA (until December 31, 2021):

• Class I medical devices

• General in vitro diagnosis

Please note that the above 12-month grace period does not apply to class I equipment and general IVD manufacturers currently required to register with MHRA.

The registration of customized equipment will be consistent with the risk level of the equipment. Failure to register by these dates means that they will no longer be able to legally launch their equipment on the UK market.

Class I equipment, custom equipment and general IVDS launched in the Northern Ireland market must continue to register normally as the 12-month grace period will not apply.

04

About ukca mark and conformity assessment organization

Ukca logo

Ukca is a new mark used to evaluate certain products on the UK market, including a new mark for medical devices to be launched in the UK.

The ukca mark will not be recognized in the EU, EEA or Northern Ireland markets, and CE marking will still be required for products currently requiring CE marking in these markets. From January 1, 2021, manufacturers will be able to use the ukca logo.

From 1 July 2023, to put the device on the UK market, you need to meet the requirements for placing ukca marks on the device. This requirement does not apply to businessmen in Northern Ireland.

British conformity assessment agency

From January 1, 2021, MHRA will be able to appoint UK accreditation bodies to assess the relevant requirements for ukca marking.

Under MDD, IVDD or aimdd, an existing UK body with a specified name will automatically flip its name without a new assignment process.

According to parts II, III and IV of mdr2002, UK accreditation bodies can only assess the conformity of medical devices, active implantable medical devices and in vitro diagnostic medical devices for ukca labeling (in the form that they exist on January 1, 2021).

First class equipment manufacturer

Manufacturers of class I medical devices and general IVD will be able to declare their compliance with parts II and IV of UK MDR 2002 (in the form of 1 January 2021) and then label them with ukca and place the device on the UK market. Class I medical devices that are sterile or have measurement functions still need to be approved by the approval authority before they can be labeled with ukca and put into the UK market.

CE mark and notice body

CE marking system is the EU's way to supervise products entering the EU market. The products with CE mark show that the products meet the requirements of EU regulations on safety, health and environmental protection. According to EU regulations, different products adopt different evaluation methods to affix CE mark. There are mainly two ways: most products can be pasted with CE mark if the manufacturer adopts self declaration of conformity; some products with relatively higher risk need to be authorized by the European Union, i.e. notified organization The CE mark can only be pasted after the conformity assessment.

Until June 30, 2023, MHRA will continue to approve the CE mark of medical devices 。

This is applicable to medical devices placed on the UK market, which have been CE marked and fully compliant with the following applicable EU regulations:

? Directive 90 / 385 / EEC on active implantable medical devices (aimdd)

◆? About medical devices (EU MDD) directive 93 / 42 / EEC

? Directive 98 / 79 / EC on in vitro diagnostic medical devices (EU IVDD)

◆? About medical device (EU MDR) Regulation 2017 / 745

In vitro diagnostic medical devices (EU ivdr) Regulation 2017 / 746

From 1 July 2023, new equipment put on the UK market will be required to comply with ukca marking requirements.

05

About masks and protective clothing

First, confirm whether the mask is a medical device. Masks can be divided into medical masks and personal protective masks. When exported to the EU, they must comply with the relevant EU regulations

1) Personal protective masks

Personal protective masks are not medical devices, but they must meet the requirements of EU personal protective equipment regulation eu2016 / 425 (PPE). The authorized notification body shall carry out CE certification and issue certificate, and the corresponding standard is en 149.

2) Medical mask

Medical masks should be in accordance with EU medical device directive 93/42/EEC（MDD） Or EU medical device regulation 2017/745（MDR） Paste CE mark, the corresponding standard is en 14683. According to the sterile or non sterile status of the mask products, the conformity assessment mode is also different.

If it is a medical mask, it needs to be further confirmed whether it is sterile:

◆ If it is a sterile medical mask, it belongs to a class of sterilized medical products in EU, CE must be carried out according to the medical device directive / regulation MDD / MDR authentication In this case, it is necessary to have authorized announcement bodies to participate.

◆ If MDR / CE is a non medical device Self declaration 。 The enterprise does not need to pass the certification of the announcement body, and can complete the declaration of conformity by itself after the corresponding documents and test reports are prepared.

3) Personal protective clothing

Personal protective clothing shall be CE certified in accordance with the EU personal protective equipment regulation EU 2016 / 425 (PPE).

4) Medical protective clothing

Medical protective clothing shall be managed according to medical devices, and sterile medical protective clothing shall be in accordance with EU medical device directive 93/42/EEC（MDD） EU regulations or medical devices 2017/745（MDR） Get CE certification. For non sterile medical protective clothing, only CE self declaration is required. ?