A lot has been happening in the world of medical devices over the last few months – we set out some key points below.
Progressive roll-out of the IVDR
As discussed in our previous blog, the European Commission published a proposal to delay the application of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (“IVDR”) by amending the transitional provisions for certain products. This was agreed by the European Parliament and the Council without any amendments to the Commission text. It has now been formally signed, and published in the Official Journal as Regulation (EU) 2022/112.
New Commission Website
You may have noticed that the Commission has updated its website, including for medical devices. In particular, there is a new sector page for devices, including sections for the Directives and new Regulations, as well as a topic of interest section. This also includes the most recent version of the rolling plan and updates on recent publications.
The Commission has published a number of new implementing acts to assist with the implementation of the Medical Device Regulations (EU) 2017/745 (“MDR”) and IVDR. Most recently:
- in November 2021, Implementing Regulation (EU) 2021/2078 was finalised, laying down rules for the application of the European Database on Medical Devices (“Eudamed”). This Regulation establishes the provisions for accessing Eudamed, the registration process, the nomenclature to be used in Eudamed, technical and administrative support, ownership and processing of personal data, functioning rules, malfunctions, websites for testing and training purposes, IT security, and fraudulent user activity within Eudamed.
- in December 2021, Implementing Regulation (EU) 2021/2226 was published, laying down rules for electronic instructions for use (“eIFUs”) of medical devices. This Regulation establishes the conditions under which information in the instructions for use may be provided by manufacturers in electronic form. It also establishes certain requirements concerning contents of websites and instructions for use that are provided in electronic form in addition to instructions for use in paper form.
The European Commission has also published two Implementing Decisions on harmonised standards in support of the MDR (Commission Implementing Decision (EU) 2022/6) and IVDR (Commission Implementing Decision (EU) 2022/15). These publications amend and enlarge the lists of references published in July 2021. Most importantly, these Regulation include ISO 13485:2016 relating to Quality Management Systems. Compliance with the updated standards provides a presumption of compliance to the corresponding requirements of the MDR/IVDR.
Recent guidance updates
In terms of guidance documents, there have been a number of recent updates including:
- MDCG 2020-16, Guidance on Classification Rules for in vitro Diagnostic Medical Devices (updated)
- MDCG 2021-28, Substantial modification of clinical investigation under the MDR
- MDCG 2021-27, Questions and Answers on Articles 13 & 14 of the MDR/IVDR; these Articles relate to the general obligations of importers and distributors respectively, and the guidance aims to provide details on their operational and practical implementation
- MDCG 2022-2, Guidance on general principles of clinical evidence for IVDs
We often receive questions about the role of economic operators under the MDR and IVDR, and so have set out some additional commentary on MDCG 2021-27 below. Determining whether an economic operator’s activities in the supply chain make them an importer or a distributor can be nuanced and, at times, unclear. This guidance helps to fill the gaps where the answer is not always clear from the Regulations. Much of the guidance is in line with the Commission’s Blue Guide, which is applicable under the current Directives. Note that the guidance is stated to apply to the MDR only, but it is expected that similar guidance will be put in place for the IVDR in due course.
- Importer vs Distributor: The guidance provides details on the distinction between these two economic operators. In particular, the importance of differentiating between the meanings of “making available on the market”, “placing on the market” and “putting into service” when considering the activities of importers and distributors. “Placing on the market” means the “first making available of a device … on the Union market”. The guidance explains that a person established in the EU will be an importer in circumstances where it obtains a device from an economic operator established outside the EU and places that individual device on the EU market. Conversely, a person will be a distributor when it sources devices from importers, distributors or manufacturers established in the EU and further distributes those devices to other entities.
- Packaging and accompanying documentation requirements: The guidance notes that importers are responsible for including their information on the device, its packaging or in accompanying documentation, whilst distributors are responsible for verifying that this obligation has been fulfilled by the importer. The guidance also confirms that in the unusual case where details of another importer already appear on the packaging of an individual device (for example, the individual device has been exported and then re-introduced to the EU market), the ‘new’ importer should contact the manufacturer to verify if the individual device has previously been placed on the EU market, to determine whether they are in fact the importer (in which case the previous label will be void), or a distributor.
- Third party logistic companies (“3PLs”): The activities of importers and distributors can be differentiated from those of 3PLs, such as those providing transportation or storage services. In general, 3PLs will not be considered as economic operators on the basis they do not have legal ownership of the devices. There should, however, be a clearly defined agreement with 3PLs setting out the responsibilities of each party. However, “fulfilment service providers” are considered to be economic operators under Regulation 2019/1020 (relating to market surveillance). These an entities which offer at least two of the following services on a commercial basis: warehousing, packaging, addressing and dispatching – without having ownership of the products involved – excluding postal services, parcel delivery services and any other postal services or freight transport services.
- Reporting requirements: Importers and distributors have a responsibility to ensure their obligations have been met, and the guidance sets out some information about how this can be done. Furthermore, if either suspect the device is non-compliant with the Regulations, each has an obligation to inform relevant parties (including the manufacturer, the authorised representative, or the importer) and not make the device available. Importers and distributors have a duty to report certain complaints to, and cooperate with member state competent authorities.
- Verification and registration obligations: Both importers and distributors have verification responsibilities, which include ensuring that the device: bears a CE mark, is accompanied by the required information, is labelled correctly and has been assigned a UDI where necessary. These legal responsibilities cannot be delegated to upstream economic operators, and whilst some operational activities may be subcontracted out, the potential liability attached to the relevant activities remains with the importer or distributor.
- EUDAMED: Importers of a device should register in EUDAMED and have various verification obligations in this regard. Whilst distributors are not required to register in EUDAMED, the national laws of members states should also be reviewed for any additional registration requirements. An economic operator which assumes the legal obligations of a manufacture should register as the manufacture in EUDAMED.
UK Guidance: Updated MHRA guidance on registration of UK Responsible Persons (UK RP)
While not related to the MDR or IVDR, the UK has also updated its guidance on registration of UK Responsible Persons (“UK RP”). In circumstances where a manufacturer of a device is based outside of the UK, they must appoint a UK RP to carry out specified tasks in relation to the manufacturer’s obligations. The UK RP must register with the MHRA.
From 1 January 2022, non-UK manufacturers must appoint a UK RP for the purposes of registering devices placed on the Great Britain market. A Northern Ireland-based Authorised Representative will no longer be able to register devices on a manufacturer’s behalf for the Great Britain market.
As such, as of 1 January 2022, the accounts of any former Great Britain-based Authorised Representatives that have not updated their role to UK RP on the MHRA registration system, as well as the accounts of any represented manufacturers, will be suspended until the UK RP has updated their role. Only then may the UK RP assume the responsibilities of the manufacturer in relation to registering the device with the MHRA. It is, however, possible for a single entity to act as both an Authorised Representative based in Northern Ireland and a UK RP. Where any changes to registrations are made, a £100 statutory fee will apply per application.