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Regulatory Advice

Due to the current COVID-19 pandemic, the European Parliament and Council have approved a proposal to delay the full implementation of the Medical Device Regulation 2017/745 (MDR) for one year to 26 May 2021. This means that the full applicability of the MDR will fall outside of the transition period agreed with the EU. In the meantime, the existing regulatory requirements should continue to be met. For full information visit: https://www.gov.uk/guidance/medical-devices-eu-regulations-for-mdr-and-ivdr

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Medical devices and diagnostics play a key role in delivering new products that benefit the NHS, the economy and above all, patients. From sticking plasters to X-ray scanners, dentures to hip joints and in-vitro diagnostic devices that monitor diabetes or identify infections; medical devices are crucial in diagnosing, preventing, monitoring and treating illness, and overcoming disabilities.

To keep up with advances in science and technology, the regulatory landscape is changing:

Two new European regulations (Medical Devices Regulation (MDR) EU 2017/745 and In-vitro Diagnostic Medical Devices Regulation (IVDR) EU 2017/746) are replacing three existing directives (Directive 90/385/EEC Active Implantable Medical Devices (AIMD), Directive 93/42/EEC Medical Devices (MDD), and Directive 98/79/EC In-Vitro Diagnostics (IVD)) in the years up to 2022. Due to the COVID-19 pandemic, the European Parliament has decided to postpone new requirements for medical devices until this time.

The new regulations have an impact on everyone involved with medical devices, from their manufacture to their use. The changes are significant and it is important that all NHS Scotland Health Boards are fully aware of the changes and start preparing for implementation and compliance of the new regulations as soon as possible.

The information on this page provides an overview of the key changes, implications and support available to ensure compliance with the new regulations. This support extends to companies or universities working in partnership with NHS Scotland to develop medical devices, ensuring high-quality advice and support is available across the health community.

Additional questions should be submitted to regulatory@shil.co.uk

The European Parliament and Council have approved a proposal to delay the full implementation of the Medical Device Regulation 2017/745 (MDR) for one year to 26 May 2021. This means that the full applicability of the MDR will fall outside of the transition period agreed with the EU.

We are taking steps to plan for after the end of the transition period. We will provide guidance on this in due course in light of Government decisions required on the future of UK regulation. All decisions on regulations will be taken with a view to prioritising patient safety and ensuring patient access for medical devices.

In the meantime, the existing regulatory requirements should continue to be met.

The new regulations include obligations that health institutions will need to meet by 26 May 2020 for medical devices and 26 May 2022 for in-vitro diagnostic devices. Health institutions are defined as “an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health” (Article2 (36) of the MDR).

NHS Scotland is not just involved in the procurement and use of medical devices, it also produces and manufactures medical devices. It is therefore vitally important all NHS Scotland health boards are fully aware of the changes and start preparing for implementation and compliance.

Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

  • diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
  • diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability
  • investigation, replacement or modification of the anatomy or of a physiological or pathological process or state
  • providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means

The following products shall also be deemed to be medical devices:

  • devices for the control or support of conception
  • products specifically intended for the cleaning, disinfection or sterilisation of device

(Article2 (1) of the MDR) - visit the MHRA website for more information on medical device regulation and safety.

  • stricter control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level
  • the reinforcement of the criteria for designation and processes for oversight of Notified Bodies
  • the inclusion of certain aesthetic devices which present the same characteristics and risk profile as analogous medical devices under the scope of these Regulations
  • the introduction of a new risk classification system for in vitro diagnostic medical devices in line with international guidance
  • improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification
  • the introduction of an “implant card” containing information about implanted medical devices for a patient
  • the reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorisation of multi-centre clinical investigations
  • the strengthening of post-market surveillance requirements for manufacturers
  • improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance

Visit the European Commission website to access additional resources and information

Some medical devices may be re-classified under the new regulation. For devices that were class I under the Directive and are reclassified into a higher risk category, these will require an appropriate Quality system and examination of the technical documentation by a notified body*. New classification rules in the regulation will be specifically relevant for:

  • Devices intended to disinfecting or sterilising medical devices
  • Software apps intended to provide information used in decisions or to monitor physiological processes

*Notified body means a conformity assessment body designated in accordance with this Regulation (Article 2 (42))

The current regulatory framework for medical devices, in vitro diagnostic medical device and active implantable medical devices do not apply to devices manufactured ‘in-house’. This means that devices manufactured and used within a single health institution are not considered as having been placed on the market or put into service and health institutions are exempt from the obligations of the directives.

The new EU Regulations for in vitro diagnostic medical devices (IVDs) and medical devices (MDs) will allow health institutions to manufacture, modify and use devices ‘on a non-industrial scale’ when equivalent ones are not available commercially assuming they are not transferred to another legal entity, however, they will now have to fulfil additional obligations.

  • Comply with general safety and performance requirements (GSPR) set out in MDR/IVDR Annex I
  • Implement an appropriate quality management system
  • Justification that the target patient group's specific needs cannot be met, or cannot be met at the appropriate level of performance by an equivalent device available on the market
  • Compile documentation on the manufacturing process, the design and performance data of the devices, including their intended purpose
  • Review the experience gained from the clinical use of the devices and take all necessary corrective actions
  • Make information available on request to competent authorities
  • Sign a declaration which will be made publicly available
  • Reviews experience gained from clinical use and take all necessary corrective actions.

(Article 5 (5) of MDR )

The UK has left the EU, and there is now a transition period until the end of 2020 while the UK and EU negotiate additional arrangements.

The current rules on trade, travel, and business for the UK and EU will continue to apply during the transition period. 

Further information is available via www.gov.uk/transition

SHIL operates an ISO 13485:2016 quality management system harmonised to the Medical Device Directive. Consultancy and advice is available to all NHS Health Boards, plus companies or universities working in partnership with NHS Scotland to develop medical devices, to ensure awareness and compliance with legal responsibilities, and to support the design and development of products under an accredited regulatory framework.

SHIL has a long record of protecting the interests of NHS Scotland. The regulatory advice service is part of a suite of professional services offered by SHIL to support innovation across NHS Scotland.

Request support or ask a question

Get in touch with the SHIL team to request support or ask a question: