EU MDR Position Statement

04th April, 2019

Background: The MDR is a significant development and strengthening of the existing regulatory system for medical devices in Europe and will replace the original directives which have been in place for over 25 years.

The European Union’s Medical Device Regulations 2017/745, or MDR, becomes fully effective for new products, or significant changes to existing products, to be placed on the EU Market from May 26th, 2020. The MDR replaces the existing Medical Device Directive, or MDD.

The legislation now being in the form of a Regulation, rather than a Directive, means that the EU law is directly enforceable at in all member states without requiring transposition by each member state into national law. This will allow for greater legal certainty and prevents variation in the approach taken or in the rules relating to medical devices that are applied across EU Member States.

Vitalograph position:

Vitalograph will continue to develop and produce medical device products that are safe, reliable and effective. The MDR is a welcome improvement in the EU regulatory system for medical devices. It will allow for an effective, consistent and robust regulatory framework for medical devices across Europe. Above all this regulation puts patient safety first.

Vitalograph have taken the following steps to ensure we can continue to legally supply, our existing MDD EC certified product portfolio to our customers after May 26th, 2020. We have requested extension of existing MDD EC certificates with our Notified Body, which will allow us to continue to place existing products, that are currently MDD EC certified, on the EU Market up until May 26th, 2024. In the interim period, we will be phasing in MDR compliance across applicable product lines. To help assist our customers in understanding whether product is conforming to the MDD or the MDR from May 2020, our EU Declaration of Conformity document will show both MDD and MDR compliance status, as appropriate, to each model series.

All new products brought to the EU market after May 2020, or significant changes to existing devices on or after this date, will fully comply with the MDR. Under the provisions outlined above, Vitalograph will continue to supply Medical Devices with MDD Certificates after May 2020.

Vitalograph management will continue to ensure we are in a state of MDR audit readiness.


MDSAP Position Statement

04th, April 2019

Background: The Medical Device Single Audit Program, or MDSAP, is a means to reduce the number of surveillance Inspections by the Regulatory Authorities from Australia, Brazil, Canada, Japan and the USA. MDSAP challenges and assesses conformance to the Medical Device Regulations and Laws of the above countries, and not to ISO. While it originally started out as a voluntary program in 2014, it became mandatory in late 2017 with Canada making it compulsory to have MDSAP certificates from Jan 01, 2019.

Vitalograph position: Following significant pressure from Medical Device companies across the globe, Health Canada amended the compliance route in 2018, as regards to medical device registration in relation to MDSAP requirements. Vitalograph confirms our compliance with these requirements, including agreement with our Auditing Organization to have an MDSAP audit in Q2, 2019. While our CMDCAS ISO 13485:2016 certificate expired in Dec 2018, as per Health Canada ruling, Vitalograph can continue to ship duly registered product into Canada.

Vitalograph management will continue to ensure we are in a state of MDSAP audit readiness.


Update - Vitalograph Brexit Statement

04th April 2019

Vitalograph will continue to monitor the situation closely. The following actions have been taken to mitigate the impact of Brexit:

  • Full review & re-stock where necessary in our UK and German warehouses to counteract any shipping delays.
  • EORI registration in place to mitigate custom’s issues with import/export between EU and UK sites.
  • Provisions to assign Vitalograph UK as manufacturer’s representative for import to UK.
  • Transfer of notified body from the British Standards Institution (BSI) UK to BSI NL to ensure validity of CE registration post Brexit.
  • We are continually reviewing MHRA guidance for the import of Medical Devices from the EU to UK. Based on current available information we can meet their requirements.

Due to the on-going uncertainty, we will continue to monitor the situation closely and will update this statement with any further new information to hand.

Vitalograph Brexit Statement

On the 23rd June 2016 the UK voted to leave the EU. Negotiations since then have yet to shed any light on what the final trading arrangements will be between the UK, the EU and the rest of the world.

To manage the risks arising from the lack of clarity, Vitalograph have instigated a Brexit contingency planning initiative, directed by our Business Continuity Planning (BCP) group to identify, address and mitigate potential risks to continuity of the supply of products and services. The ever-changing situation is reviewed on a regular basis and all the main potential risks have been identified and addressed at this stage.

Please note that Vitalograph has business operations located in multiple, diverse countries with critical suppliers multi-sourced from different geographies.

Should any customer require any further detail on our Brexit preparations then please contact brexitplanning@vitalograph.co.uk


Quality Assurance

Quality assurance extends throughout all functions in Vitalograph for greater company efficiency and improvement of product and customer service. We have implemented all relevant Clinical, Data, Management, Training, Distribution and Service Standards.

ICH – GCP E6 (R2)

International Conference on Harmonisation (ICH) GCP guidelines provide internationally accepted ethical and scientific guidance covering the design, conduct, records and reporting of Clinical Trials to ensure these ensure the safety of Patients, the integrity of Trial data and that the conduct of Trials is carried out in conformance to Good Clinical Practice. Vitalograph operate in full compliance with this.


ISO/IEC 27001

ISO/IEC 27001 is an information security management system to keep information assets secure. It is a systematic approach to managing sensitive company information, providing a framework for managing the security of our assets including personal data, financial information, intellectual property, employee details and information entrusted to us by third parties.

It is kept under continual review to refine the way we do this now and in the future. ISO 27001 is supported by its code of practice for information security management, ISO/IEC 27002 and there are more than a dozen standards in the 27000 family. Vitalograph is in the final stages of implementation with full alignment to ISO/IEC 27001 planned in 2018.


Design and Manufacture

The main Vitalograph manufacturing facility is located in Ennis, Ireland. Quality assurance extends throughout all functions at Vitalograph for greater company efficiency and improvement of product and customer service.

ISO 13485 - Certificate: MD 82182

ISO 13485 specifies requirements for quality management systems in order to achieve regulatory compliance in the medical devices industries. The requirements given in this standard are applicable to the design, development, production, installation and servicing of medical devices of all kinds. It describes concepts and methods that can be considered by organisations which are establishing and maintaining quality management systems.

Medical devices have special requirements over and above consumer products for safety and efficiency; these are covered in this standard to ensure full product reliability and traceability, starting with the design process through to their use on patients. Vitalograph have been certified to conform to this standard and its predecessors for over 35 years.


IEC 62304 Medical Device Software Life Cycle

Vitalograph fully complies with the international standard IEC 62304 medical device software standard which has been harmonized by the European Union and the United States. This standard is a requirement for the development and maintenance of medical device software which includes software used on a mobile device such as a Smartphone and also applies to software intended as a standalone medical device and within medical devices.

It is intended to cover the whole software lifecycle, from initial specification, safety classification, software development process, development process documentation, software maintenance, software risk management, configuration management and the software problem resolution process. The software element is a component of ISO 14971 process for medical devices risk management.


FDA Quality System Regulation (QSR), CFR 820

The Food and Drug Administration has provided guidance and standards to manufacturers supplying medical product and devices to the USA since the 1970s; Vitalograph is registered and regularly inspected on the application of these.


FDA Pre-market Approval

The introduction of new medical devices onto the US market requires submission to the FDA of full documentation on the safety and efficacy of any new products - this is incorporated into the design stage of all Vitalograph products to ensure full compliance with the legal requirements.


CE Marking

The European Community recognised the need for harmonized standards on Medical device safety, and published the Medical Device Directives in 1995, laying down essential requirements for product safety, with guidelines for ensuring safety even when no particular standards existed. These are obligatory for all products placed on the market after June 1998. All Vitalograph medical devices and software have been CE marked since January 1996.

Our notified body is BSI (0086). The new European Medical Devices Regulation (MDR) was published in May 2016. It will replace the Medical Devices Directive (93/42/EEC) in 2019 after a 3-year transition period. Vitalograph is working with the notified body to update all technical documentation and processes to meet the new requirements of the MDR.


MDSAP

Vitalograph are in the process of a series of audits which will culminate in participation in the Medical Device Single Audit Program (MDSAP) by the end of 2018. MDSAP enables Vitalograph as a medical device manufacturer to have a single audit of our QMS certify for compliance with the standards and regulatory requirements of several participating regulatory jurisdictions. Auditing organizations are authorized by the participating regulatory authorities of five countries, namely Australia, Brazil, Canada, Japan and the United States to conduct audits under MDSAP.


JPAL

The Japan Pharmaceutical Affairs Law (JPAL) is a quality management system and GMP requirements similar to ISO 13485 with the additional provisions applied Mutatis Mutandis. Specifically Vitalograph medical devices and software comply with Japanese MHLW Ministerial Ordinance No. 169, standards for Manufacturing Control and Quality Control for Medical Devices (and In-Vitro Diagnostic Reagents). This requires leadership, commitment and active involvement from our top management.


CMDCAS - Certificate: FM 83550

In Canada, regulations require that certain medical devices be designed and manufactured under a registered quality management system (QMS), which came into force on January 1, 2003. The Canadian Medical Devices Conformity Assessment System (CMDCAS) was developed by Health Canada's Therapeutic Products Directorate (TPD), in collaboration with the Standards Council of Canada (SCC).

The role of the Standards Council in CMDCAS is to qualify the organisations that register the QMS of medical device manufacturers. Under this sector-specific program, only SCC accredited registration bodies are eligible to register manufacturers. Vitalograph have been successfully audited and accredited to the CMDCAS regulatory requirements by the British Standards Institute (BSI).


Safety and Performance Standards

IEC 60601-1 series Medical electrical equipment

This International standard is in a number of parts, covering electrical safety, RFI/EMC, and other safety aspects of electrical products. Vitalograph Products have been certified to conform to the appropriate parts since their inception in the late 1970s, providing a clear assurance of safety in line with the essential requirements.


ISO EN 10079-2 Manually powered suction equipment

Section three of this standard covers human powered suction equipment, and was produced to ensure effective performance of these devices in emergency use; Vitalograph were pleased to participate in this standard, and the Emergency Aspirator fully conforms to these requirements.


ISO 10651–4 Operator-powered resuscitators

ISO 10651-4 specifies requirements for operator-powered resuscitators intended for use with all age groups and which are portable and intended to provide lung ventilation to individuals whose breathing is inadequate. Operator-powered resuscitators for infants and children are designated according to body mass range and approximate age equivalent.

ISO 10651-4 is not applicable to electrically- and gas-powered resuscitators. The predecessor to ISO 10651-4, ISO 8382 also covered operator powered resuscitators, providing guidance on their performance and safety; Vitalograph was pleased to participate in this standard, and the Resuscitators supplied by Vitalograph conformed to this standard until it was replaced by ISO 10651-4. Vitalograph Resuscitator fully complies with this new standard.


ISO 26782 Spirometers

This performance and safety standard specifies requirements for spirometers intended for the assessment of pulmonary function in humans. This includes the measurement timed forced expired volumes, either as part of an integrated lung function device or as a stand-alone device. It applies to all spirometers regardless of the measurement method: flow-sensing, volume displacement and any other methods.


ISO 23747 Peak Flow Meters

This performance and safety standard addresses the discrepancy in readings obtained from peak flow meters and spirometers, together with issues caused by the peak flow meters with the Wright's scale, which is non-linear. The standard requires testing for accuracy, reproducibility and frequency response. A meter with poor frequency response will result in errors leading to potential issues diagnosing and monitoring lung conditions. The standard also requires the meters to be checked for accuracy on a routine basis, as recommended by the manufacturer.


IEC EN 60601-2-27 ECG Devices and Software

This performance and safety standard relates to medical electrical equipment. Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment. Vitalograph manufactures ECG devices and software in conformance to this standard.


IEC EN 60645-1 & ANSI/ASA S3.6 Audiometers

Audiometers are electronic instruments intended for the testing of human hearing. These performance and safety standards relate to specifications and tolerances for audiometric measurement equipment for audiometry testing. Vitalograph provides devices and software in conformance to these standards.


NIOSH CWHSP

The National Institute for Occupational Safety and Health (NIOSH) operates the Coal Workers’ Health Surveillance Program (CWHSP) which provides respiratory health screening and surveillance to U.S. coal miners. Under this program, coal miners are entitled to respiratory health screening via questionnaires, chest radiography, and spirometry upon entry into the coal mining workforce and then periodically throughout their careers.

NIOSH approved CWHSP medical facilities providing respiratory health screening for miners must use spirometers that meet specific NIOSH requirements regarding the output data and content of spirometry test reports. Vitalograph Pneumotrac Spirotrac and Vitalograph COMPACT Workstation have the report and electronic data transfer file approved.


Clinical Practice Guidelines

The American Thoracic Society (ATS)

The American Thoracic Society (ATS) publishes documents which include clinical practice guidelines, policy statements, research statements, technical statements and workshop reports. Many of these are developed collaboratively with other professional societies, such as the ERS. ATS official documents include technical statements which describe how to perform a test or procedure and describe the underlying evidence. For Vitalograph the ATS statements on Pulmonary Function Testing (PFT) are particularly relevant.

The American Thoracic Society first produced guidelines for spirometry in 1979, which were last updated with a family of guidelines in 2005 when they jointly published with the ERS (See below). Since 2005 there have been several technical statements in PFT including:

  • Field Walking Tests in Chronic Respiratory Disease: Official ATS/ERS Technical Statement (2014)
  • Single-Breath Carbon Monoxide Uptake in the Lung: An Official ATS/ERS Technical Statement Executive Summary (2017)
  • Single-Breath Carbon Monoxide Uptake in the Lung: An Official ATS/ERS Technical Statement (2017)
  • Standardized pulmonary function reporting: An Official ATS Technical Statement (2017)

Vitalograph equipment is kept up to date to enable clinicians to meet all these guidelines.


The European Respiratory Society (ERS)

ERS guidelines provide clarity and direction for a number of topics in respiratory medicine with the aim of improving clinical practice. Many are produced in collaboration with other societies to ensure they are wide-reaching and useful to the international respiratory community as a whole. Vitalograph equipment is kept current to enable clinicians to meet or exceed these guidelines.

The European Respiratory Society was commissioned to produce spirometry guidelines and 'normal values' by the European Coal and Steel Community in the 1960s, which developed into a family of guidelines published in 2005 jointly with the ATS:

  • Standardisation of the single-breath determination of carbon monoxide uptake in the lung 2005
  • Standardisation of the measurement of lung volumes 2005
  • Standardisation of lung function testing - Interpretative strategies for lung function tests 2005
  • General considerations for lung function testing 2005

Since then many guidelines have been published, including:

  • Multi-ethnic reference values for spirometry for the 3–95-yr age range: the global lung function equations 2012
  • Guidelines for the management of work-related asthma 2012
  • ERS/ATS Consensus statement for inert gas washout measurement using multiple- and single-breath tests 2013
  • Expert opinion on the cough hypersensitivity syndrome in respiratory medicine 2014
  • An official European Respiratory Society statement on physical activity in COPD 2014
  • International ERS/ATS Guidelines on Definition, Evaluation and Treatment of Severe Asthma 2014
  • Global Strategy for Diagnosis, Management, and Prevention of COPD 2016
  • Global Lung Function Initiative reference values for the carbon monoxide transfer factor for Caucasians
  • European Respiratory Society technical standard: exhaled biomarkers in lung disease 2017
  • Management of COPD exacerbations: a European Respiratory Society/American Thoracic Society guideline 2017
  • ERS/ATS standards for single-breath carbon monoxide uptake in the lung 2017
  • Standardisation and application of the single-breath determination of nitric oxide uptake in the lung 2017

The ERS also has a number of Ongoing Task Forces including:

  • Exhaled biomarkers in lung disease (FENO and EBC) TF-2012-11
  • Statement on Technical Standards for the Forced Oscillation Technique TF-2014-17
  • Update of ATS/ERS standardisation of the single breath uptake of CO in the lung (DLCO) TF-2014-19
  • Statement on Electronic Cigarettes TF-2014-22
  • Standardization of the single-breath determination of nitric oxide uptake in the lung (DLNO) TF-2014-24
  • The Occupational Burden of Respiratory Disease TF-2015-14
  • Global Lung Function Initiative (GLI): Deriving global multi-ethnic reference values for the measurement of lung volumes TF-2015-19
  • Standardisation of Cardiopulmonary Exercise Testing in Chronic Lung Diseases TF-2016-12

GLI

The Global Lung Function Initiative (GLI) compiled normal lung function equations for several population groups in the age range 2 to 95 years for the key spirometry indices FEV1 and FVC plus their ratio. These closely correlate with NHANES values with the exception of the ratio. Four GLI population groups are published so far, named ‘Caucasians’, ‘SE Asians’, ‘NE Asians’, ‘African Americans’ and a fifth ‘Other’ (to include Asian, Oriental, European, Scandinavian and every other population). Stanojevic S, Wade A, Stocks J, et al. published 'Reference ranges for spirometry across all ages. A new approach’ in Am J Respir Crit Care Med 2008; 177: 253–260.

This led to the GLI becoming an ERS task force in 2010 and this task force commenced to develop normal value reference equations for Carbon Monoxide Transfer Factor (TLCO or DLCO). The GLI network administers the lung function data repository securely stored by the ERS. The GLI database is available to researchers to conduct answer research questions. The task force intends to continue to develop new reference values for the measurement of lung volumes. All current Vitalograph lung function measurement devices incorporate the GLI normal values to the latest revision. See http://www.lungfunction.org and also: vitalograph.co.uk/resources/normal-values