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Anne Matousek
Senior Consultant QM & RA, Regulatory Affairs Expert

Tel.: 07131 2774-40
regulatoryaffairs(at)seleon.de

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10.02.2021

The English Way, aka "UK MDR 2002"

Trade with the United Kingdom will become more complicated after Brexit, also with regard to the medical devices sector. Among other things, every company must mandate a UK responsible person in order to achieve the UKCA.

UK-MDR-2002
UK-MDR-2002
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UK-MDR-2002

In the news around the turn of the year, one could hardly escape this announcement. The Brexit transition period ended on 31 December 2020. This means that there will be a customs border between the states of the European Union and the United Kingdom from 1 January 2021. This poses a new challenge for the economy.

 

For medical device manufacturers, but not only them, the following now applies:

There is a "UKCA" marking based on its own legislation, the Medical Devices Regulation 2002 (SI 2002 No 618). Yes, please take a look once more, it is indeed the "UK MDR 2002" and not an accidental number mistake from last year!

The three main types of medical devices covered by the UK MDR 2002 and the parts associated with each are:

  • General medical devices: Part II of the UK MDR 2002
  • Active implantable medical devices: Part III of the UK MDR 2002
  • In vitro diagnostic medical devices (IVDs): Part IV of the UK MDR 2002

The requirements of the legislation are already familiar to most manufacturers from the relevant European directives respectively

The geographical scope for this MDR 2002 is England, Wales and Scotland.

 

The special case of Northern Ireland

For Northern Ireland, on the other hand, other rules apply, such as European rules.

Otherwise it would have been too easy!

Medical devices offered on the Northern Irish market still require a CE mark, i.e. the EU regulations must be complied with.

In order to affix a CE mark on the medical device for circulation in Northern Ireland and the EU, a Notified Body recognised by the EU must be involved for third party conformity assessment.

Where a UK Notified Body is involved for third party conformity assessment for the Northern Ireland market, the UKNI mark must be added in addition to the CE mark. The UKNI mark is never affixed alone - it is always accompanied by a CE mark.

In addition, special reporting requirements apply to Northern Ireland with the MHRA. Further information can be found here.

 

The good news

For medical devices, the CE mark will be accepted in the UK until 30 June 2023, which means that either the CE or UKCA mark will be required for placing the products on the market.

However, since 1 January 2021, subsequent products must be registered with the MHRA in Great Britain (England, Wales and Scotland) under the existing regulations if the manufacturer is based in the UK or the authorised representative is based in Northern Ireland (there is no grace period):

  • Class I medical devices
  • General IVDs
  • Custom-made products
  • Systems and treatment units

Manufacturers based outside the United Kingdom require a "UK responsible person" for registration, This person must be based in the UK, see here for more information. The name and address of the "UK responsible person" must be indicated on the medical device next to the UKCA mark.

Currently, European manufacturers are already searching for such a UK responsible person. Unfortunately, there is currently (as of 30 January 2020) no listing of this function, but there is a listing of all manufacturers in the UK, so perhaps volunteers will be found here. Under certain circumstances, importers based in the UK might also want to take on this role.

The UK government indicated the following qualifying periods for registration:

The following products need to be registered with the MHRA if they are to continue to be marketed in the UK from 1 May 2021:

  • Active implantable medical devices
  • Class III medical devices
  • Class IIb implantable medical devices
  • IVD List A products

The following products need to be registered with the MHRA if they continue to be marketed in the UK from 1 September 2021:

  • Class IIb non-implantable medical devices
  • Class IIa medical devices
  • IVD List B products
  • Self-test IVDs

The following devices must be registered with the MHRA if they are (to continue to be) placed on the market in the UK from 1 January 2022 (Attention! This only applies to manufacturers or authorised representatives who are not based in the UK. ):

  • Class I medical devices
  • General IVDs

There is no grace period for manufacturers based in the UK or authorised agents based in Northern Ireland!

The possibility to register products before the above mentioned dates shall be given, but there is no legal obligation to do so.

 

Conclusion:

If your medical device already carries a CE mark, sooner or later, depending on the class of product, you will need to find a UK responsible person and register your product in the UK.

You have until 2023 to meet the requirements for a UKCA, use it well!

If new question marks now pop into your head at the sight of these additional registration tasks, we will be happy to assist you in complying with UK requirements.

 

Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.

Due to the recent rapid changes in UK legislation, there may be changes in legal or regulatory requirements at short notice which we are unable to reflect on a daily basis.

Every product is unique – the mandatory tasks and measures for entering the market need to be specified individually. seleon advises you on your individual questions without any obligation.

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