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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

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.

Breaking News – The New Regulation on Medical Devices (MDR) and Regulation on In-Vitro Diagnostic Medical Devices (IVDR) are now Published

On 5th May 2017 the new Regulation on medical devices (EU 2017/745) and a Regulation on in-vitro diagnostic medical devices (EU 2017/746) were published, these replace the existing Directives.

These new rules will only apply after a transitional period, 3 years after entry into force for the Regulation on medical devices and 5 years after entry into force for the Regulation on in-vitro diagnostic medical devices.

With these new Regulations the burden of responsibility increases on all commercial entities, especially EU Authorised Representatives such as Advena, therefore the times ahead are expected to be challenging for all concerned.

Advena with our team of experts and range of services are well placed to help and advise clients through the applicable transitional period.

Virtual Manufacturing Replaces OBL

The new guidance on Virtual Manufacturing has been published by the MHRA. The document, titled “Virtual Manufacturing replaces Own Brand Labelling for medical device manufacturers” can be found here[1]. As the title suggests, this replaces the previous OBL guidance and its requirements must be met by 1st September 2017.

One of the critical new requirements is that such manufacturers must now have their own Quality Management System audited, and their technical documentation reviewed by notified bodies. This manufacturer, now termed the “Virtual Manufacturer”, is considered as “the natural or legal person who places a new or fully refurbished device on the market under his name despite not undertaking the design or manufacture of the medical device itself”. Previously, such manufacturers got away with holding Summary Technical Documentation (STED), however are now expected to hold the full technical documentation for any product they register under their name. The documentation will then be reviewed by a Notified Body (NB) or Competent Authority (CA). In cases where the manufacturer does not hold the rights to the product design, the NB or CA may accept certain design information to be redacted, however this should be limited as much as possible and must not hinder their assessment. In such cases, the virtual manufacturer shall ensure that a mutual contractual agreement is in place with the Original Equipment Manufacturer (OEM) such that the CA may access this redacted information.

Previously, manufacturers of class I devices or IVDs were not expected to register these products. The new guidance clearly states that this is no longer the case, and such devices must be registered with the appropriate CA. The technical documentation is expected to be well integrated into the manufacturer’s quality system, with references to instructions for use, labels, risk management and so on. Furthermore, the technical documentation must include a statement by the virtual manufacturer stating that “they fully understand all the documentation provided and that they accept full legal responsibility”.

The minimum requirements present in the contractual agreement between the virtual manufacturer and OEM can be found on the MHRA guidance document, however have been provided below:

  1. A direct link between the medical devices being placed on the market by the manufacturer that holds the rights to the product design and the virtual manufacturer they are supplying who does not hold the design rights (e.g. by name / part number).
  2. Arrangements for post market surveillance and vigilance activities (i.e. details of who is responsible for what in relation to these requirements, including reporting of adverse incidents). All virtual manufacturers should ensure that incidents or potential incidents are reported and also brought to the attention of the manufacturer that holds the rights to the product design. Similarly, the manufacturer is responsible for notifying the virtual manufacturer to enable them to take appropriate action with regard to their own products.
  3. Provisions for post-production follow-up, including ensuring that post market clinical follow up provisions are in place.
  4. Arrangements for details of any changes to the medical devices to be notified to both parties.
  5. Provisions for unannounced audits – i.e. the notified body of the virtual manufacturer will be required to have access to any critical suppliers (including the manufacturer who holds the rights to the design).
  6. The contract should include the fact that the virtual manufacturer may not enter into another contract with another virtual manufacturer for the same device, i.e. a virtual manufacturer cannot be the OEM for another virtual manufacturer for the same medical device.
  7. Provision for the OEM (including the manufacturer who holds the rights to the design) to provide fully un-redacted information upon request of the notified body of the virtual manufacturer, without the requirement for further contractual actions between the notified body and critical supplier such as non-disclosure agreements.
  8. Provision for the OEM, where relevant, to maintain and provide to the virtual manufacturer notified body certification covering the products concerned.
  9. Provision for the OEM, where relevant, to maintain and provide to the virtual manufacturer evidence of registration (e.g. for their Class I devices, IVDs etc.) with their Competent Authority.

We understand that these new requirements may seem daunting to some who have been operating as an OBL under the previous guidance. Advena has the right expertise to guide you through this transition and build your technical documentation. For further information and guidance, please do not hesitate to contact us.

[1] https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/604371/Own-Brand-Labelling-toVirtual-Manufacturing-Final.pdf

Medical Device Regulation: Technical File Requirements

There is a concern that many manufacturers who CE mark class I medical devices do not have adequate technical (safety) data to provide in the event of a European complaint, regulatory or vigilance enquiry. The fact that class I devices are “self-certified” does not absolve the manufacturer from having sufficient technical and safety data to support their marketing activities in the EU.

In addition, as from mid-year (probably May / June), anyone who exports medical devices into the EU may have to assure that their importer, and authorised representative (such as ourselves), has suitable access to the company technical documentation to demonstrate conformity to the regulations. So, in that respect, importers and authorised representatives could be asked to show how they can gain access to device technical files in a timely manner. To not be able to do this could mean exposure to legal issues and, in particular product liability claims, as all economic operators could be held liable to assure device conformity.

We strongly urge these processes to be considered as soon as possible before the new EU regulations are upon you;

  1. Assure you have up-to-date, signed and approved regulatory files that are reviewed for completeness. Such files should concentrate on safety (by risk management) and a demonstration of conformity to the EU “Essential Requirements” (Now called “General Safety and Performance Requirements” in the Regulations) by using a check list. All manufacturers selling in the EU must have a suitable “Declaration of Conformity”. If you are an Advena Ltd. Authorised Representative client you will know we insist on the latter before we will contract with you.
  2. Assure that your importers (that is the businesses who first bring your devices into the EU – you may have several) understand their responsibilities for being able to access your technical data.

NOTE:    Having access to technical files does not mean the economic operator having the information physically on file in their premises, although this may be the way you want to work.  As most technical file documents are live, and subject to continual improvement and update, this information could be on a cloud server with permission to be being given in the event of a regulatory enquiry. However, Authorised Representatives must be able to show they have verified that the text is available and complete.

Any Non-EU medical devices manufacturers seeking an EU Authorised Representative (EC REP) should contact Advena Limited by email: info@advenmedical.com to request detailed information about our services and a quotation.

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