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EN ISO 62304: 2006 Medical Device Software Validation

The topic of software validation is one that continues to cause confusion, so we have developed a series of flowcharts to help clarify the requirements. These cover:

* EN ISO 62304; 2006 medical device software – software life cycle processes
* FDA General Principles of Software Validation; Final Guidance for Industry and FDA Staff

Please contact Farhaan Shaikh on +44 (0)1926 800153 or via email to farhaan.shaikh@advenamedical.com for further information.

Meet Advena at MEDICA 2014 – Düsseldorf

For those of you visiting MEDICA in Dusseldorf on November 12th to 15th you will find John Adcock and Farhaan Shaikh available to meet face to face on both Thursday and Friday. This is a big opportunity to network so let us know early if you will be there so we can arrange to get together.

Particularly on the Thursday we will be at the UK Pavilion in Hall 16 using the facilities of the Association of British Healthcare Industries (ABHI) with meeting tables, meeting rooms and refreshments. If you would like to discuss with us any regulatory and or quality issues please email now to book our time early.

On the Friday we will also be available to meet any clients who have their own booths, again let us know well in advance, the area is huge and we will have to plan our visits accordingly.

The show runs from 10.00 until 18.30 each day.

We look forward to meeting all our clients who will be in Germany at that time, as well as a lot of new faces!

New Quality Management Requirements for OBL Manufacturers

Quality Management System

In relation to the Quality Management System [QMS] the OBL will be expected to maintain a QMS which covers the requirements as defined in the Medical Device Directive or IVD Directive as relevant. This does not mean that a fully compliant ISO13485 system must be in place although if this is the case it will simplify the process as ISO 13485 is the harmonized standard under both the MDD and IVDD for the QMS requirements.

The OBL documented quality system must cover the following areas as a minimum

  • Internal Audit,
  • Management Review,
  • Traceability,
  • Regulatory Requirements [e.g. Vigilance, Post Market Surveillance, Post Market Clinical Follow Up, informing regulatory authorities of vigilance issues],
  • Quality Objectives,
  • Complaints,
  • Order  processing and client communications
  • Document Control and Records
  • Organizational Structures and Responsibilities,
  • Control of the Manufacturing Process including any in-line or final performance testing and Non-Confirming Product,
  • Corrective and Preventive Action
  • Purchasing and Control of 3rd parties [including the OEM and other critical suppliers] must be included in the OBL quality system

These areas will be reviewed during your yearly assessment audits.

For those companies who OBL Class IIb or Class III medical devices, or List A / List B / Self Test IVD devices under Annex IV, it is mandatory to have Design Processes within your QMS. This does not have to cover design to first principles but as a minimum it must include how you as the legal manufacturer agree any changes to the design of the product.

As stated above this requirement cannot be delegated to the OEM it must also be under your control, so a formal procedure detailing how you manage design changes is required and a lack of such a procedure will result in a Major Non-Conformance.

Unannounced audits

Unannounced audits are required to be conducted at the place of manufacture of the devices and it is likely that these audits will be conducted at the premises of the OEM.

The costs will be charged to you as the legal manufacturer.

In your agreement with the OEM there will need to be a clause where the OEM allows these audits to take place without hindrance.  If an unannounced audit is refused by the OEM, a Major Non-Conformance will be raised which may lead to suspension of your certification and you will still be liable for any costs associated with the audit.

Discover more about Advena’s Medical Device Regulatory Consulting and Quality Management Services, or contact us on +44 (0) 1926 800 153 or via email to info@advenamedical.com

Key Own-Branding Guidance for OBL Manufacturers

OBL Guidance to Clients

This article is now obsolete and has been replaced by our article on Virtual Manufacturing, which has replaced OBL. Press here to be redirected.

As you are probably aware there have been significant changes to the requirements of Own Brand Labelling [OBL] in relation to the MDD 93/42/EEC and IVDD 98/79/EC contained in the Commission Recommendation 2013/473/EU, which was released in September 2013.

This document made clear the Commission view that OBL manufacturers should be viewed in the same way as all other legal manufacturers of medical devices and should not be subject to a lighter conformity assessment process

The following email is therefore being sent to explain these expectations and the requirements that you as the legal manufacturer will be required to carry out.

One area which has already been completed is the process of ensuring that annual on-site audits are conducted, no longer can the complete CE certification process be completed off-site. SGS have already informed those affected clients of this change and from the end of June 2014 we will not be conducting any more of these purely off-site audits.

The main point to state is that the previous concept of OBL being able to pass responsibilities to their OEM is no longer acceptable; the concept is now that you will be considered to be “virtual” manufacturers.  Other important changes are as follows.

Technical agreement

You will still require to have a formal agreement with the Original Equipment Manufacturer  [OEM] as presently which will define the responsibilities of each party but no longer can an OBL delegate any regulatory function to the OEM, these must now be fully under the control of the OBL.

The formal agreement as a minimum must include the following:

  • A direct link between the OEM and OBL products
  • Provision of technical documentation by the OEM to be held by the OBL
  • Notification of design changes by the OEM to the OBL prior to implementation and updating of the technical documentation held by the OBL
  • A clause allowing access to the OEM’s full technical documentation by regulatory bodies and your Notified Body.
  • A clause allowing your Notified body to undertake unannounced audits at the OEM
  • Responsibility for design, translation and affixing of labelling and IFUs
  • Arrangements for Customer Complaints ,Vigilance, FSN, Post Market Surveillance and Post Market Clinical Follow Up activities and the communication of any issues between the two parties.
  • Document Retention Times
  • Traceability requirements.

Access to OEM technical documentation

The OBL as a minimum must have a copy of the STED [Summary Technical Documentation as defined in the GHTF document SG1/N011R20 for medical devices or GHTF/SG1/N063 for IVD devices], this is sometimes known as Part A of the technical file.

This STED document will be reviewed as part of the yearly on-site assessment audit or if as an OBL you have a large number of STED’s a sample will be checked. We will not be conducting a full in-depth technical review of the STED as the full technical file should have been reviewed by the OEM’s Notified Body but if we do find significant omissions from the STED then we will raised Major Non-conformities on the OBL.

If there is any specific propriety information of a confidential nature in the full technical file it is accepted that this information may not be passed to the OBL. This policy has been confirmed as acceptable by the regulatory authorities but the rationale for this omission will be reviewed during the audit and it is expected that the OBL will be aware of the omission of this data.

Discover more about Advena’s Medical Device Regulatory Consulting and Quality Management Services, or contact us on +44 (0) 1926 800 153 or via email to info@advenamedical.com

Notified Body Unannounced Audits

SGS Notified Body presented a very interesting Webinar on November 13th (some of you may have been joining in) and this presentation was repeated again during the MEDICA show in Düsseldorf.

The story remains unchanged with Notified Bodies making it very clear that from January 2014 the audit processes will be changing for all manufacturers and distributors who use an EU Notified Body to issue a CE certificate.

This is VERY significant for clients who use Notified Bodies and these changes must be understood

  • Unannounced audits (similar to that for the food industry) will be mandatory for all Notified Body CE certified manufacturers and these manufacturers’ significant sub-contractors.
  • Such unannounced audits will be once every 3 years by 2 auditors from 8.30 am, for one day. They may be more frequent for high risk devices and if a significant subcontractor makes the whole device the unannounced audits could also be more frequent.
  • A “responsible person” must always be available.
  • If the facility is not operating, or closed, or entry refused, then the client has to still pay an audit fee and get a major non-conformity. Hence Notified Body must be told of periods of inactivity when audits cannot be made. This must be specified in the manufacturer’s contract with the Notified Body.
  • For unannounced audits of 3rd party suppliers / OEMs there may be an opportunity for companies to notify beforehand when operations will be running, or facilities open.
  • There needs to be in the contract between the manufacturer and their supplier / OEM to allow unannounced audits to take place.
  • The primary site audited will be the one with the name and address on the device label; i.e. the company site responsible for legal activities, even own-branders, who subsequently will have their OEM audited.
  • Lack of competence or awareness of regulations will be non-conformity.
  • Risk management to EN 14971: 2012 will always be required.
  • Clinical data must be complete to MEDDEV 2.7.1. Notified Bodies are now required to employ qualified clinicians or equivalent to review and approve data.
  • The EU MEDDEV guidance documents (http://meddev.info/) will all be regarded now as law, not just guidance. All manufacturers will be expected to have knowledge of MEDDEVS
  • Post market surveillance records will be inspected, and they will look for feedback from users/patients as well as distributors, so a manufacturer can no longer rely on distributors for handling reports.
  • Technical files must cover all variants and device family members and this must be clear within the
  • documents. All technical documents must be up-to-date, a 2-3 year review may not be acceptable when known changes have been announced. (e.g. referring to up-issued standards)
  • Device must be shown to have a “medical purpose” as per the definitions of medical devices.
  • Device designs must show to be “state-of-the-art”, i.e. using modern technology and/or be the subject of continuous design improvement.
  • Notified Bodies expect the fee to increase by 20-50%, and Notified Bodies are unlikely to give fixed price contracts in the future.
  • Some Notified Bodies will lose their approval to certify to the Medical Devices Directives. Manufacturers can check the NANDO web-site that gives latest Notified Body news and for any of these organisations that has been de-designated for medical devices. If your Notified Body looses it medical device designation you have to find a new one ASAP. http://ec.europa.eu/enterprise/newapproach/nando/

Discover more about Advena’s Medical Device Regulatory Consulting Sevices or contact us on +44 (0) 1926 800 153 or via email to info@advenamedical.com

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