Regulation comes into life 1 July 2023.

However, the transition period may vary depending probably on device’s risk
category. That is not clear yet. We make general IVDs with lowest risk class possible so hopefully we will be the last ones
under MHRA eye.
So far this is called “proposition’ but most of those will be included in final version as the majority of new requirements
are based on EU / FDA requirements. Most important changes below.

Quality Management System

Currently, under the UK medical devices regulations, the manufacturer has an obligation to have a QMS in place and
there are no more details how such QMS should look like (ISO13485 is mentioned in EU Regulation, which is not valid
for the UK).

Change. The MHRA considers that the UK medical devices regulations could be amended to clarify that all
manufacturers should have a QMS in place which addresses at least the following aspects:
1. a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for
management of modifications to the medical devices covered by the system
2. identification of applicable essential requirements and exploration of options to address those requirements
3. responsibility of the management
4. resource management, including selection and control of suppliers and subcontractors
5. risk management
6. clinical evaluation, including post-market clinical follow-up (PMCF)
7. product realisation, including planning, design, development, production, and service provision
8. verification of the UDI assignments
9. setting-up, implementation and maintenance of a post-market surveillance system
10. handling communication with competent authorities, Approved Bodies, other economic operators, customers and/or other
stakeholders
11. processes for reporting of serious incidents and field safety corrective actions in the context of vigilance
12. management of corrective and preventive actions and verification of their effectiveness
13. processes for monitoring and measurement of output, data analysis and product improvement
14. requirements for management review
15. requirements for internal audit.

Qualified Person (in EU: Person Responsible for Regulatory Compliance)

The UK medical devices regulations do not include any requirements for manufacturers to appoint a Qualified Person.

Change. At least one Qualified Person with qualifications or regulatory experience that exceeds minimum standards that
would be set out in the UK medical devices regulations in the field of MD / IVDs. This could include, for example, a
formal qualification in law, medicine, pharmacy, bioscience or another relevant scientific discipline, or sufficient
professional experience in Regulatory Affairs or in QMS relating to medical devices.
The MHRA considers that small and medium enterprises (SMEs) could be excluded from this requirement and instead
be required to always have a QP permanently and continuously at their disposal able for contact.

Distance sales
The UK medical devices regulations do not include requirements for distance sales of medical devices / IVDs.
By distance sales MHRA are referring to MD / IVDs that are sold at a distance via electronic means - e.g. via websites
and app stores. This would apply, for example, to an individual buying a thermometer over the internet, or to a patient
with diabetes purchasing an app which helps them to monitor their blood sugar levels.

Change. The MHRA considers that the UK medical devices regulations could be amended to clarify that a medical device
must comply with the UK medical devices regulations if it is sold or provided at a distance through electronic means.
This would be the responsibility of the person selling the device.
The MHRA considers that the UK medical devices regulations could be amended to provide that, upon request from the
MHRA, any individual, company or organisation offering a medical device by means of distance sales could be required
to provide a copy of the Declaration of Conformity (a declaration that the device complies with the UK medical devices
regulations) of the medical device concerned.

Registration and UDI

The goal is to increase traceability including better supply chain control.
 Each device will have to have UDI (Unique Device Identifier) which is in line with EU and FDA requirements. UDI-DI
and UDI-PI will be required, the same number will be needed outside of the UK for EU and US markets. Those
numbers will need to be printed on the labels and included in Declarations of Conformity (or Certificates of
Conformity, if the product needs to be assessed by Approved Body).
 Introduction of Great Britain database on medical devices which will include: registration data, vigilance, post-
market surveillance, and market surveillance regarding medical devices.
 Registration at MHRA – instead of few types of information entered during registration of a device at MHRA there
will be so called “List One” with 42 positions to be documented. Insane!
 Declaration of Conformity – a lot more detailed.

Chapter 9 IVDs / Section 54 - Generic Tests

The UK medical devices regulations do not currently include specific requirements relating to genetic testing.
Under the current regulations it is possible for a genetic test to receive a CE or UKCA marking on the basis of an
analytical study which demonstrates the medical device performance. This is due to these devices being classified as
low-risk devices under the current UK medical device regulations. There has been a long-standing concern amongst
stakeholders that the current regulatory requirements are not sufficiently robust within this area. This includes
requirements around the information provided to users of genetic tests.

Change. The UK medical device regulations could be amended to reflect some of the concerns raised such as those
relating to the risk classification of genetic tests and ensuring users of genetic tests are provided with the appropriate
information on the nature, significance, and implications of their test. That brings us to the next topic: performance
evaluation requirements.

Performance evaluation requirements

The MHRA has identified that the UK medical devices regulations could be amended to provide additional requirements
for IVD manufacturers conducting performance evaluations. This could include more detailed requirements for the
scope and content of a performance evaluation, including how a manufacturer must demonstrate the scientific validity
and the analytical and clinical performance of the IVD. It could also include more detailed requirements regarding how
the manufacturer should demonstrate that they have sufficient clinical evidence (data which shows the medical device
is safe and performs as intended) and how a performance evaluation should be documented.

The environment
Environmental and public health impact assessments: introducing a requirement for manufacturers to complete, as part
of their conformity assessment for a medical device, an assessment of the device’s impact on both the environment and
public health. Examples of information this might capture include waste and emissions associated with the device and
whether it can be reused, re-processed or recycled. A summary of the assessment could be made publicly available to
support more informed medical device use choices.
Introduce a requirement that devices must be designed and manufactured in a way that reduces, as far as possible, the
risks posed to public health by substances or particles that may be released from the device including wear debris,
degradation of products and processing residues.