In this post, 3 of 4, we’ll consider Medical Device Regulations in the EU and the UK.
In the other parts of this Post we have …
- Definitions of Medical Devices - ISO 13485 vs. EU versus USA
- Classification of Medical Devices in the EU versus USA
- The Medical Device Regulations of the United States (FDA)
- The Medical Device Regulations of the MDSAP Countries
- The Medical Device Regulations of the Rest of the World (WHO)
Note: The only certainty about this Post is that its content is almost certainly out-of-date. It is not an exaggeration to describe the current European regulatory scene as chaotic and the situation across the globe as being in a state of flux.
The situation described here refers to the situation at the time of writing, early January 2021. But by the time you come to read this the only certainty is that things will have changed.
Be forewarned and, if not an expert yourself, be sure to consult an expert to establish definitively the regulatory position regarding your medical device products and the markets you propose to sell them in.
Medical Device Standards
Before examining the Regulatory position, let’s briefly consider the ISO standards that have an ever more important relationship to the Regulations.
The ISO standards for medical devices are covered by ICS 11.100.20 and 11.040.01. The quality management system and risk management regarding the topic for regulatory purposes are covered by ISO 13485 and ISO 14971.
Quality Management Systems in compliance with ISO 13485 is an actual or de facto requirement under the EU and USA regulatory frameworks and under the MDSAP Programme.
Further standards are IEC 60601-1 and for medical software IEC 62304. US FDA also published a series of guidance documents for industry regarding this topic against 21 CFR Subchapter H -Medical Devices.
The Medical Device Regulations of the European Union (EMA)
As mentioned above the regulations apply if the EU and EFTA Countries are MDR 2017/745, which also covers Active Implantable Medical Devices (AIMDR), and IVDR 2017/746.
Just a few days ahead of schedule the new Medical Device Regulations (MDR), Active Implantable Medical Device Regulations (AIMDR), and the In Vitro Medical Device Regulations (IVDR) came into force on 20th May 2017.
Impact on Component Manufacturers and Suppliers
Does your company supply, or plan to supply, products (including component, printing and labelling, and packaging) and services (distribution and logistics) to the medical device supply chain? If so, you definitely need to know the new Regulations and their impact.
The new Regulations, the ISO 13485:2016 Standard, and other changes will greatly affect manufacturers of Medical Devices; to a lesser extent suppliers of products and services to the medical device supply chain will also be affected (and ISO 9001 Certification is unlikely to be sufficient).
The regulatory changes apply to the entire supply chain, and the entire life cycle of medical devices. Component manufacturers, packaging and labeling manufacturers, logistics companies, and all suppliers of services (including end-of-life disposal) to the supply chain will need ISO 13485 Certification as part of proving their compliance with the Regulations. They will not need the services of a Notified Body.
Consequently, your company needs to 1) get informed and 2) prepare a Transition Plan without delay. You may also wish to talk with a Regulatory Affairs advisor.
The Regulatory ‘Big Picture’ as of February 2021
A Post of this title was published recently.
The EUDAMED Medical Device Database
The creation of a European database on medical devices (EUDAMED) is one of the key aspects of the new rules on medical devices (MRD) and in vitro diagnostic medical devices (IVDR).
The EU claims that EUDAMED will provide a ‘living picture of the lifecycle of medical devices that are made available in the EU Regulatory Area. It will integrate different electronic systems to collate and process information about medical devices and related companies (e.g., manufacturers). In doing so, EUDAMED aims to enhance overall transparency, including the provision of better access to information for the public and healthcare professionals, and to enhance coordination between the different Member States in the EU.
EUDAMED will be composed of six modules related to:
- actor registration (the Single Registration Number – SRN - has been active since December 1st, 2020),
- unique device identification (UDI) device registration,
- notified bodies and certificates,
- clinical investigations and performance studies,
- vigilance, and
- market surveillance
Manufacturers have questioned the added-value and risk-reduction potential of this project.
The date of application of the MDR is now May 2021 following delays caused by Covid-19.
Manufacturers have expressed concern regarding the imminent introduction of and transition to a Unique Device Identification system, called UDI, which is part of EUDAMED. There is the potential to disrupt supplies of affected devices as the proposed changes affect the marking on the devices themselves.
The UDI is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. It allows the unambiguous identification of a specific medical device on the market.
The UDI is comprised of the UDI-DI and UDI-PI. The unique identifier may include information on the lot or serial number and be able to be applied anywhere in the world.
The production of a UDI comprises the following:
- A UDI device identifier (‘UDI-DI’) specific to a device, providing access to the information laid down in Part B of Annex VI.
- A UDI production identifier (‘UDI-PI’) that identifies the unit of device production and if applicable the packaged devices, as specified in Part C of Annex VI.
The UDI will be placed on the device itself, on the label or on the package of the device.
The obligation for submission of UDI data in the EUDAMED database applies from 26 November 2022 for medical devices and 26 November 2023 for in vitro diagnostic medical devices (provided that EUDAMED is fully functional before the date of application of the respective Regulation; otherwise, this obligation applies 24 months after EUDAMED has become fully functional). There are later deadlines for Class 1 MDs and Class A IVDs.
The FDA also has a UDI Programme. Coordination between the EMA and the FDA is ongoing with a view to avoiding confusion and duplication in the marketplace.
The Medical Device Regulations of the United Kingdom (MHRA)
The EU-UK Trade and Cooperation Agreement of December 2020 does not provide for any mutual recognition of standards for medical devices, meaning device makers will need to navigate different regulatory regimes for the EU and UK.
Companies will also need to decipher added regulatory complexities related to Northern Ireland, which will follow EU rules for medicinal products and medical devices according to the Northern Ireland Protocol.
The new system came into effect on 1 January 2021, with certain devices allowed a grace period for registration. Each new registration has a statutory fee of £100.
The main changes to how medical devices are placed on the market in Great Britain (England, Wales, and Scotland) are…
- CE marking will continue to be recognised in Great Britain until 30 June 2023
- certificates issued by EU-recognised Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023
- the EU no longer recognises UK Notified Bodies
- UK Notified Bodies are not able to issue CE certificates (other than for the purposes of the “CE UKNI” marking, which will be valid in Northern Ireland) - and have become UK Approved Bodies
- a new route to market and product marking is available for manufacturers wishing to place a device on the Great Britain market
- since 1 January 2021, all medical devices, including in vitro diagnostic medical devices (IVDs), placed on the Great Britain market need to be registered with the MHRA. There is a grace period for registering:
- Class IIIs and Class IIb implantables, and all active implantable medical devices and IVD List A products must be registered from 1 May 2021
- other Class IIb and all Class IIa devices and IVD List B products and Self-Test IVDs must be registered from 1 September 2021
- Class I devices, custom-made devices and general IVDs (that do not currently need to be registered) must be registered from 1 January 2022
- manufacturers of Class I devices, custom-made devices and general IVDs that, prior to 1 January 2021, were required to register their devices with the MHRA (i.e., UK-based manufacturers or third country manufacturers with Northern Ireland-based Authorised Representatives) must continue to register their devices from 1 January 2021 on the same basis as they do now rather than in line with the above dates
- manufacturers based outside the UK wishing to place a device on the Great Britain market, need to appoint a single UK Responsible Person who will take responsibility for the product in Great Britain. Further detail here UK Responsible Person.
The MHRA announced in December 2020 that the long-term regulatory scenario in the UK has not as yet been determined.
As we’ve said previously applicable definitions, classification and regulation vary with location and, while there is a drive towards a uniform global system, we’re not there yet. Consequently, we’ll examine the situation in a series of 4 posts, namely,
- Definition of medical devices, ISO 13485 vs EU vs the USA
- Classification of Medical Devices, EU vs the USA
- Regulatory Regimes, EU, UK
- Regulatory Regimes, USA, MDSAP Countries, and the Rest of the World.