skip to Main Content
+44 (0) 1926 800 153 info@advenamedical.com

Advena Add More Experience to Their Team

This month we welcome Richard Bassett to our team at Advena Limited., as our newest Senior Regulatory Consultant and QMS expert.

Some of you will already know Richard as he is joining us from a well-known major UK Notified Body where he has been a Client Manager and Lead Auditor. This has included working as a Lead Assessor for EN ISO 13485 and ISO 9001 systems covering all medical devices including IVD devices. Richard is a certified Auditor for almost all aspects of device CE marking, CMDCAS and overseas GMP requirements and has been closely involved in managing Notified Body audit teams. Richard is also an MDSAP lead auditor.

Specifically, Richard has been involved in management teams responsible for Quality Management Systems and Technical Files which included IVD Devices, Pregnancy Test Kits, Contact Lens Solutions, Eye Drops and Ear Drops plus the management and execution of associated supplier and internal audits.

This experience has involved working with risk management and the preparation of technical documentation including the classification conversion of cosmetic products to medical devices – an important issue under the new MDR and IVDR regulations.

Richard’s qualifications include an MSc in Structural Molecular Biology with a dissertation on the Structure and Function of Antibodies (specific to IVD research) and he is now completing a dissertation on Medical Device Regulation. These higher level qualifications complement an earlier BSc in Biomedical Science where study topics included biochemistry, medical microbiology, biotechnology, genetics, and immunology.

Richard’s background is specifically of note when considering the new classification systems for IVD devices in the EU.

Undoubtedly Richard has a wealth of experience to offer our existing and prospective clients alike and we welcome him to our expanding company. If like many of our clients you are looking for excellent experienced regulatory support please email Advena for a solution to meet your regulatory needs, please email: info@advenamedical.com

Brexit and the UK Medical Device Industry

There has been a lot of uncertainly about how Brexit is going to affect medical device manufacturers in the UK.

Here at Advena we track the UK political news closely and feel now that unless there is significant shift in Westminster a “hard” Brexit may be almost inevitable.

This is emphasised by the UK Notified Bodies silently assuring they have an EU base so they may continue certifications.

For our non-EU clients this is no problem, we will change AR address and registrations to our Malta office but for those based in the UK there could be little alternative than to assign an EU Authorised Representative (with an EU office, such as ourselves) for label references and any applicable registrations so the CE marking may continue.

For a UK manufacturer to have to contract with an Authorised Representative consultancy in mainland Europe, with all the currency and associated language issues, may seem like a bridge too far when viewed alongside all the other regulatory changes on the horizon.

However, we at Advena thought about this possible outcome almost 2 years ago and now, with our established and manned office in Malta, we are able to offer a smooth transition without changing our administration and English language communication base in the UK.

For any EU medical device manufacturers concerned about this possible impact they should contact us now so we can offer a “pre-mandate” ready for such an eventuality at 30% off our standard AR fees for the first year. No invoice would then be raised until political necessity arises and a swift change over to the Maltese address, and any accompanying registrations can be made.

Contact our team if you want to know more and stop worrying about Brexit!

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!

Back To Top