Distribution 

Before making a device available on the market, distributors must verify that all of the following requirements are met:
  • the device has been CE marked and that the EU declaration of conformity of the device has been drawn up
  • the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(11)
  • for imported devices, the importer has complied with the requirements set out in Article 13(3) that where applicable, a UDI has been assigned by the manufacturer
  • Distributors shall ensure that, while the device is under their responsibility, storage or transport conditions comply with the conditions set by the manufacturer and must engage in post-market surveillance (and post market clinical follow up if appropriate)
  • Distributors shall, upon request by a competent authority, provide them with all the information and documentation that is at their disposal and is necessary to demonstrate the conformity of a device
  • The distributor accepts significant additional regulatory burden and risks with the mandatory requirements to verify that the manufacturer and the importer (where applicable) have complied with EU MDR requirements in Article 13
  • The Distributor shall take safeguarding and corrective measures against medical devices posing a risk to public health, full traceability and ability to perform recalls is essential

“We adhere to high ethical standards and never compromise our stakeholders”

GS1 and peppol

  • Following Lord Carter’s report, “Operational Productivity and Performance in English NHS Acute Hospitals: Unwarranted variations” the Department of Health mandated that every service and product procured by an NHS Acute Trust in England must be compliant with GS1 and PEPPOL standards. The current deadline for compliance is 2019/20
  • Implementing GS1 labelling and location standards was mandated in the Department of Health eProcurement strategy (2014)
  • PEPPOL (Pan European Public Procurement Online) offers is a standardised connection for e-ordering, e-invoicing, electronic credit notes and advanced shipping notifications (ASNs)

Code of conduct

Market expectations are that all persons representing ethical medical companies will abide by a code of conduct that will not jeopardise the reputation of any of the stakeholders
  • Eucomed Code of ethical Business Practice and ABHI – guidelines on interactions with healthcare professionals
  • The NHS Supply Chain expect all our suppliers, i.e., all companies who do business with them, to adhere to the same ethical principles. For this purpose, NHS Supply Chain has drawn up this Supplier Code of Conduct, which sets the standards for doing business with them
  • NHS Trusts and employees are subject to guidelines on interactions on managing conflicts of interest
  • The UK government introduced a legal duty requiring all businesses above a certain size to disclose annually what action they are taking to ensure that their business and supply chains are not tainted by modern slavery
  • Interactions with Healthcare Professionals and organisations are subject to the Bribery Act

Market access

UK NHS Market Access The Future Operating Model for the NHS will have significant impact on the access to the market

  • Tenders
  • Drug Tariff
  • NHS Trusts Direct
  • Accelerated Access Pathways
  • Category Procurement Towers
  • Intelligent Client Coordinator
  • Clinical And Product Assurance

Clinical

  • Together with our associate clinical team we can facilitate market evaluations, clinical trials and gather evidence to support product efficacy
  • We can support PMCF and PMS activities
  • We can act as product advisors or support training and educational programmes to improve health care outcomes
  • We can liaise with end users and be the primary point of contact for clinical support

Marketing

  • Communication with the end user is as critical in health care as it is in other sectors
  • The health care buying process can be much more complex and results do not always follow activity
  • Data is key to ensuring success, CreedMed work with data analytic companies to determine an appropriate and cost effective marketing strategy
  • We can source or provide sales and marketing resources aligned to a business growth plan
  • We can design a communication strategy that will maximise the potential of a product
  • We will take a step approach to manage investment risk and reward

Quality and regulatory

  • The CE mark holder has the primary legal responsibility to ensure the safety, suitability and quality of the products it supplies
  • A good partner will help ensure the CE mark holder meets its obligations and can provide guidance and support in the specific markets where they act as the manufacturers representative
  • This may involve Post Market Clinical Follow-up (PMCF) and Post Market Surveillance (PMS)
  • A robust and appropriate logistics operation to maintain the product quality and achieve timely delivery to the customer with full trace ability