On 01 September 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance on how medical devices will be regulated in the UK from 01 January 2021, following the UK departure from the European Union.
What does this mean for Australian based medical device manufacturers wishing to place their device on the UK market?
The UKCA Mark
If you are an Australian medical device manufacturer wishing to market your product in Great Britain (England, Wales and Scotland), you will need to place a UKCA mark on your product. The UKCA mark is not recognised in the EU or Northern Ireland markets. A CE mark or a CE UKNI mark will be required for devices placed on the Northern Ireland market.
UKCA mark requirements for medical devices are based on the 3 main types of medical devices and their associated Part in the UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002):
- 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
A conformity assessment will be required to demonstrate a medical device meets the requirements set out in the UK MDR 2002 regulation.
As of 01 January 2021, the UKCA mark is available for use. However, during the transition period, the MHRA will continue to recognise EU CE marks until 30 June 2023. Following this, new medical devices placed on the GB market will need to conform with the new UKCA marking requirements.
Certificates issued by EU Notified Bodies will remain valid in GB until 30 June 2023.
UK Approved Bodies | MHRA Medical Device Requirements
An Approved Body is an organisation that has been designated by the MHRA to assess whether a medical device meets the requirements set out in the UK MDR 2002 regulation.
UK Approved Bodies conduct conformity assessments in relation to the UKCA mark. UK Approved Bodies are not able to conduct conformity assessments for EU CE marking other than for the purposed CE UKNI which is applicable to Northern Ireland.
Responsibilities of the UK Approved Body include but not limited to:
- Assessing the manufacturer’s quality system including production, inspection and final inspection
- Assessing the full design dossier relating to each type of product
- Assessing the full technical information relating to each type of product and carry out appropriate testing of a representative sample of production to ensure requirements are met
- Test every unit or every batch of product to ensure before the manufacturer can place them onto the market
- Conducting unannounced audits of manufacturers
UK Responsible Person | Authorised Representative
If a manufacturer is based outside the EU, they are required to assign an Authorised Representative in order to place a medical device in the EU market. Under the requirements set out in the UK MDR and MHRA guidance, a UK Responsible Person will need to be appointed in order for a device to be marketed in the GB market. The responsibilities between the EU Authorised Representative and the UK Responsible Person are largely aligned.
Responsibilities of the UK Responsible Person include but not limited to:
- Ensuring the declaration of conformity and technical documentation are available
- Ensuring an appropriate conformity assessment procedure has been carried out by the manufacturer
- Cooperating with the MHRA on any preventive or corrective action taken to eliminate or mitigate risks posed by devices
- Immediately informing the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been appointed
The name and address of the UK Responsible Person, where applicable, must be included on product labelling where the UKCA mark has been affixed. Details of the UK Responsible Person do not need to be included on labelling for CE marked devices.
Australian based manufacturers should aim to appoint their UK Responsible Person as soon as possible.
Device Registration with the MHRA | All Medical Devices Need to be Registered
Historically only limited classes of medical devices were required to be registered with the MHRA. In line with the UK MDR and MHRA guidance, from 01 January 2021 all medical devices that will be marketed in the UK need to be registered with the MHRA. For Australian medical device manufacturers, the UK Responsible Person who has a place of business in the UK, will be responsible for ensuring the device is registered with the MHRA. Distribution and suppliers are not required to register with the MHRA.
Manufacturers will be allowed a grace period of 4-12 months for registering their devices.
- Class III, Class IIb implantables, active implantable medical devices, and IVD List A – by 30 April 2021
- Other Class IIb and all Class IIa – by 31 August 2021
- Class I devices and general IVDs – by 31 December 2021
Brexit impact on the MHRA and the UK pharmaceutical manufacturers (pharmout.net)
Medical Device Registration TGA Australia Standards (pharmout.net)
Medical Device Regulation (MDR) – 11 Key Changes (pharmout.net)