Article 117 of EU MDR: What will your submission file look like?

The objective of Article 117 of the EU MDR is to involve the right stakeholders in the review process: review of device by Notified Body (NB) and to also meet the expectations of the European Medicines Agency (EMA) and/or National Competent Authorities (NCAs). According to the second subparagraph of Article 117 the opinion issued by a NB applies to “the conformity of the device part with the relevant general safety and performance requirements (GSPRs) set out in Annex I  to that Regulation”.

What are these considerations and how would you structure your submission?

The format, contents and depth of data/testing for a medical device submission vary considerably across medical device classes and also within a certain medical device class. If product standards are available, manufacturers tend to stick to those. In such instances the standards and contents could be highly similar for all products falling in within such a product group.  To effectively navigate this maze of formats/ guidance/industry practices and finally submit the right content for review to right stakeholder, is the end goal of this review!!  The Team NB position paper explains “For medical devices being solely governed by the MDR, the documentation requirements related to the GSPRs are described in Annex II Technical Documentation (MDR, Annex II; specifically, section 4). These documentation requirements should also be considered for the documentation of the device part.’’

Amongst other things, the position paper further elaborates on the key aspects of the Technical File:

1. A general description of the device part including its intended purpose and intended users,
2. The intended patient population and medical conditions to be diagnosed, treated and/or monitored and other considerations such as patient selection criteria, indications, contra-indications, warnings (for the integral product/ single integral product)
3. The principles of operation of the device part and its mode of action, scientifically demonstrated if necessary,

All the requirements are outlined.

Format requirements such as, being legible, searchable, bookmarks, hyperlinks etc. are quite standard, similar to the ones you would follow for the medicinal product dossier.

Crucially on the point of impact assessment, the paper mentions “the influence of the other device, product or substance on the device part to be assessed” and “aspect of impact assessment also applies to specific manufacturing technologies”.

The Technical File forms the basis of the application and the impact assessment is a tool to illustrate compliance with GSPR. In the Technical File, it is important to assess what are the parts of your medical device - is it a single device or you have more components, accessories or even instruments as part of a kit!  Is it a standard device or was it made specifically to accommodate your clinical requirements or product administration related considerations? 

The next step is to start with the CE status of your product.  Once the accessories and components have been identified, ascertain if they fall under the same CE or multiple CE certificates.  For CE bearing products, talking to your supplier about the MDR transition plans would be very important. Otherwise look into the technical documentation available at your end. Evaluate if you have had any usability or compatibility testing/ data, product testing data, stability, manufacturing process controls, especially if you have a legacy device.

During the product development cycle, it is useful to review the CE status of the device, whether it is still the same or were there any significant changes made or are these changes under review. Most of the time, your change control process would have considered all these changes, but it does help to be aware and be sure of this, as the historical information is crucial.  It is not looking back, but to look forward with the view to rationalize any manufacturing/ testing/post market data/studies to support evidence of compliance. All the pieces of information fall into right places when you think about what the reviewer is looking for. A summary of all the testing/data to sufficiently prove the compliance with GSPR would be ideal for review.

Qserve will elaborate which GSPRs could be crucial for you in coming posts, so stay tuned!

And do reach out to Qserve for assistance on all the device related submissions, meetings with the NBs, and specific project based consultations in case you are not sure if your product falls under Article 117.