Medical Devices in the EU: Low-Risk Device Challenges

The following is the fourth in the series of blogs related to some of the key challenges being encountered due to the recent updates to EU MDR. Read the other posts about; understanding medical device equivalence vs demonstration of equivalence, post-market clinical follow-up requirements for EU MDR and The New European Union MDR: Impact on Technical Files

Specific areas manufacturers need to watch out for, are the changing MDR Classification rules in Annex VIII. Manufacturers need to determine whether new conformity assessment routes are now applicable to their device portfolios and if their devices still fall into the same regulatory risk classification or they have been up classified. Changes have been made to the way that medical devices are classified, with requirements being increasingly scrutinised based on the risk posed to patients. Once you confirm the scope of your product fits the definition in article 2 and that it is a medical device, you then need to ensure that the product is classified correctly, and this should be conducted following the classification rules described in Annex VIII of the EU MDR 2017/745.

There are ‘extra requirements’ for devices that fall into any of the following categories; sterile, reusable surgical or has a measuring function.

The only available Conformity Assessment route for self-certified class I devices is to create and maintain technical documentation in compliance with Annex II & III. For class I (other requirements Is, Im, Ir), a limited QMS should be in place to ensure production controls are in place, as is detailed in Annex XI-Part A, or you may choose Annex IX – Chapter I, depending on which route suits your needs.

Once determined, you should ensure that your products meet the relevant ‘General Safety Performance Requirements’ (GSPRs) listed in Annex I of the MDR and IVDR. The benefits of using the device must outweigh risks and achieve the claimed performance. This must be proven with supporting clinical evidence or investigation, chemical, physical and biological properties. The ‘General Safety Performance Requirements’ (GSPR’s), are based on the previous Essential Requirements laid out in the MDD 93/42/EEC and AIMD 90/385/EEC, however, they are now much more prescriptive (thankfully). You will now see specific requirements for products containing nano particles. Also requirements for usability have been called out in much more detail, focusing on protecting the ‘layperson’ and addressing specific use risks. Historically this has been a problematic area, causing much confusion to manufacturers about what is required for legacy devices and the best way to address the requirement.

The regulation also calls out very specific requirements on what needs to be contained on the label. For instance,‘Unique Device Identification’ (UDI) is a new requirement, which is causing manufacturers many problems as new software, systems and processes are required and to accommodate this. There are also many new requirements in the labelling section of Annex I, whereby you are now required to identify your product as a ‘Medical Device’. New requirements relating to information on your Instructions for use e.g. bearing a notice to the user and/or patient that serious incidents should be reported to the manufacturer and competent authority. While the concept of serious incident reporting/vigilance reporting is not new, it was not previously required to inform users or patients in the IFU that such incidents should be reported. Patient reporting of adverse events would likely be new to manufacturers and may require new procedures and investigation practices. However, for class (I & IIa) devices, it is not mandatory to supply Instructions For Use, with your product, as long as the device can be used safely without.

Some of the other key problems that have already been highlighted in industry relate to changes. The concept of how this will work is still unclear. Typically, self-certified manufacturers would need to notify their Competent Authority (CA) about more administrative changes, for instance things like; registered address, company name, company type, adding or removing device(s) to your registration record, change of authorised representative (AR), change of contact details including email addresses and telephone numbers.

For true Class I Devices you do not have an obligation to tell the Competent Authority (CA) each time there is a change to the product, although this should be documented in your technical documentation, with a solid QMS process that is super sensitive to changes. The Competent Authority (CAs) do not currently have mechanisms to check product changes or to deal with the queries.

Manufacturers must also register their devices on European Database on Medical Devices (EUDAMED). Your organization will be assigned a Single Registration Number (SRN) as is described in article 30 and 31 (if applicable) of the MDR.

It is the manufacturer’s responsibility to register a medical device. You will get assigned a basic UDI-DI. Until EUDAMED is fully functional, manufacturers and EU representatives must notify the competent authority (CA) and register the device.

You should be fully familiar with the MDR in its entirety, although the following articles in the MDR will have the most impact on you. You must ensure that you completely fulfil the requirements set out below;

• Article 2 – Definitions (ensure your product fits the definition of a medical device)
• Article 10 – General obligations of manufacturers
• Article 15 – Person responsible for regulatory Compliance
• Article 19 – EU Declaration of Conformity
• Article 20 – CE marking of Conformity
• Article 25 – Identification within the supply chain
• Article 27 – Unique Device Identification System
• Article 29 – Registration of Devices
• Article 31 – Registration of manufacturers, authorised representatives and importers
• Article 51 – Classification of devices
• Article 52 – Conformity Assessment Procedures
• Article 61 – Clinical Evaluation
• Article 62 – Clinical Investigations
• Article 83 – Post Market Surveillance system of the manufacturer
• Article 85 – Post Market Surveillance Report
• Article 87 – Vigilance

The annexes provide detailed information as to how you should meet the articles, which is the law:

• Annex I – General Safety and Performance Requirements (GSPR’s)
• Annex II – Technical Documentation
• Annex III – Technical Documentation on Post Market Surveillance
• Annex IV – EU Declaration of Conformity
• Annex V – CE Marking of Conformity
• Annex VI – Information to be submitted upon registration of devices and Economic Operators, core data elements relating to UDI
• Annex VIII – Classification, the applicable annex based on Conformity Assessment
• Annex XIV – Clinical Evaluation and Post market Clinical Follow-Up
• Annex XV & XVI

There is no doubt that the changes we are facing in industry with the introduction of MDR are huge, complex, time-consuming and costly. Transitioning to the MDR might seem overwhelming and many companies don’t know where to start or get lost along the way. Therefore, you need to be well informed about how best to strategize effectively. By engaging with Celegence, your organization can leverage our quality and regulatory expertise to solve complex challenges.

The Celegence team can provide complete end-to-end solutions for medical device compliance. We can help to perform gap analysis of your existing documentation and close any gaps that we may find. Our team can supply simple templates and design regulatory and QMS strategies that help you gain CE approval, deal with any classification/conformity assessment dilemmas you may have, help to assess changes, and help steer you in the right direction to ensure that you remain compliant. We believe in “Right First Time” approach when it comes to technical documentation and clinical reporting. We will share our years of knowledge and know-how, deliver an advantageous set of services related to matching people’s needs to expertise and deliver services on time, ensuring your continued route to market.