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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.

Medical Device Regulation: Reprocessing of Single-Use Devices

The final draft of the Medical Device Regulation (MDR) clarifies what will be legally expected of health institutions, or by external parties on their behalf, who opt for the reprocessing of single-use devices.

A single-use device, as is implied by its name, is a device which is intended to be used on a single patient for a single procedure. This means that such a device should not be used again on the same patient, and is not intended to be reprocessed. The current symbol being used to indicate a single-use device is shown below. Tighter healthcare budgets and resource restrictions may lead some institutions to reprocess such single-use devices. Increasing regulation on these processes reduces the risks involved.

The MDR states that further use and reprocessing of single-use devices must be performed only where permitted by national law and only when such a process complies with the requirements set out in the Regulation. Furthermore, the reprocessor will be considered to be the manufacturer of the reprocessed device and will assume the obligations under the Regulation.

However, Member States will have the power to decide that the obligations of a health institution or its external reprocessor may differ from the obligations set out for manufacturers in the Regulation. Such divergence from the Regulation shall only be permitted when the health institution or external reprocessor complies with the relevant common specifications, or in their absence, with harmonised standards and national provisions.

If a Member State decides that a health institution or its reprocessor shall not meet the obligations set out for manufacturers in the Regulation, they must ensure that a detailed risk management, validation of the processes involved, performance testing, quality management system, incident reporting, and traceability of reprocessed devices are in performed. Some Member States may also demand health institutions to provide patients with information on the use of reprocessed devices with which they are treated with. On the other hand, Member States may decide to further restrict, or event prohibit the use of reprocessed single-use devices in their territory.

The Regulation will also demand that the reprocessing of any device should have the same level of safety and performance as the original device. This ensures that such devices will be able to be re-used in a safe manner. Only reprocessing procedures which have been deemed safe by recent scientific evaluation may be carried out.

The term reprocessing is now defined as the

process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device. [Article 2(39) of the MDR]

All reprocessed devices must be issued with an indication that they are reprocessed devices, how many reprocessing cycles have taken place, as well as the reprocessing cycle limit.

We’ll keep you informed on any changes which may occur.

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