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Meet Advena at Arab Health 2018

Advena will be located in Hall 7, Stand H7C50 at this important show in Dubai from 29th January to 1st February 2018.

We will be available to meet clients old and new during this trade show and have access to meeting room facilities at the ABHI UK Pavilion. We advise those who would like to meet one of our team to contact Anthony Kirby (Anthony.kirby@advenamedical.com) well in advance as the meeting room needs to be booked for any extended conversations or product reviews.

If you are planning to visit Advena at Arab Health please order your visitor pass now to secure your free pass and avoid the on-site registration fee. To register visit www.arabhealthonline.com/rsvp.

Further details about Arab Health 2018 may be found at https://www.arabhealthonline.com/en/Home.html

Anthony Kirby
Director of Business Services
Kenneth Shaw
Regulatory Associate

Reusable Surgical Instruments in EU Regulation 2017/745

A Reusable Surgical Instrument is defined as: “an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out.” – 2.3, Chapter I, Annex VIII.

It should be noted that only devices without a connection to an active medical device can be defined in this manner, otherwise they will be given a higher classification. Examples of devices falling into this class include:

  • Scalpels and scalpel handles
  • Reamers
  • Drill bits
  • Saws, that are not intended for connection to an active device
  • Retractors, forceps, excavators, and chisels
  • Sternum retractors for transient use.

Considerations in the Medical Device Regulation

Under the current Medical Device Directive, these devices fall under Class I, with no Notified Body (NB) involvement (unless sold sterile). Similarly, the Medical Device Regulation also classifies these devices as Class I, however will now require Notified Body involvement with respect to the following aspects relevant to the reuse of the device:

  • Cleaning
  • Disinfection
  • Sterilisation
  • Maintenance and functional testing
  • Related instructions for use.

In line with point 7 of Article 52 of the MDR, the manufacturer will be required to:

  • Issue a Declaration of Conformity
  • Establish and maintain the technical documentation in accordance with Annexes II and III
  • Apply the procedures laid out in either Chapter I and III of Annex IX, or in Part A of Annex XI.

Conformity assessment with respect to Annex IX will be based on a Quality Management System and on the assessment of technical documentation, whilst a conformity assessment with respect to Annex XI will be based on product conformity verification.

This situation is very similar to that of Class I devices supplied in a sterile condition, or with a measuring function. It is evident that a vital part of conformity with the Regulation will be to provide detailed procedures for the processes involved in preparing the device for reuse. The manufacturer must also supply information on the validated method of re-sterilisation appropriate to the Member State in which the device is placed on the market.

Furthermore, the manufacturer must provide the end-user with information indicating the limitations of reuse so as to maintain device safety and performance. Such information could include the maximum allowable number of reuses, or guidance on how to recognise the signs of material degradation which could indicate that the device is no longer safe to use. Information on the maximum amount of times the device can be reused will eventually need to be provided to the UDI database. In addition to this, it is also required that any traceability, or safety information present on the device should remain legible after every preparation for reuse.

If you require any assistance on bringing your Reusable Surgical Instruments into conformity with the MDR, please do not hesitate to contact us at info@advenamedical.com.

Intended Use VS Indications For Use

Over the years, the amount of regulatory terminology seems to grow at a constant rate, and so it is no surprise that even the more fundamental terms start getting confused. We have seen many cases in which “Intended Use” and “Indications for Use” have been used interchangeably. Sometimes, “Indications for Use” are not even considered! So why does it matter?

The “intended use” of a device is critical for determining its classification, and is usually defined during the initial regulatory stages. However, the “intended use” is often misunderstood. Its purpose is not to describe what the device is intended to be used for. Instead, it should lay out the claims of what your device is meant to do. This is precisely why the classification will be based on the intended use, that is, on the manufacturer’s claims. It is good practice to keep the intended use statement concise, as long as it details all the fundamental claims appropriately.

On the other hand, the “indications for use” will lay out the conditions in which the user would use the device, that is, the reason or situation for use.

If you have any further questions, please let us know!

Avoid This Major Non-Conformity

A Major UK based Notified Body recently issued a major non-conformity to a medical device manufacturer in South Africa.

 

The auditor was not satisfied with the arrangements in place between the manufacturer and their EU Authorised Representative (EC Rep), in particular that their EC Rep was not a member of the European Association of Authorised Representatives (EAAR).

It should therefore come as a great comfort to our clients and prospective clients alike that Advena are not just a member of this respected organisation by are a founding member.

If this is an example of how Notified Bodies intend assessing a manufacturers EC Rep it should help make the decision process much simpler.

By choosing Advena as your EC Rep, you not only gain access to our regulatory experts, extensive experience and knowledgeable advice, you avoid this major non-conformity.

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