Guidelines For Medical Device Procurement Under the EU MDR Published

Guidelines For Medical Device Procurement Under the EU MDR Published

A European non-governmental organization (NGO) has published guidelines to help hospitals safely procure medical devices, a year before the new European Union (EU) Medical Device Regulation (MDR) is due to take effect.

Healthcare Without Harm (HCWH) Europe released the guidelines recommending the following steps:

  • Conduct a baseline assessment to view the entire procurement process.
  • Prioritize products according to the EU MDR.
  • Identify safer and more sustainable alternatives.
  • Raise internal awareness.
  • Prepare contracts (including a list of hazardous substances to avoid).

The document suggests purchasing stakeholders include health professionals, lawyers, patients and patient groups, senior management and policy makers, among others. Processes should aim to phase out medical devices that may have harmful substances present, and replace them with safer alternatives.

Hospitals and medical facilities are the largest purchasers of medical devices in scope of the new EU MDR, which range from stethoscopes to pacemakers. As the new regulation comes into effect in May 2020, a database of legal information on medical devices (EUDAMED) will be developed. This database will increase transparency and be accessible to procurement teams in charge of purchasing decisions.


Learn more about the requirements under the new EU MDR regulation by downloading our eBook, Understanding the EU Medical Device Regulation.


The guidance notes that healthcare procurement officers account for an average of 7.1 percent of the GDP in EU countries, and thus have the ability to influence the market with demand for safe products.

The new EU MDR requires companies to certify products according to the new standards, only allowing hazardous substances in a concentration below the 0.1 percent weight by weight limit, unless adequate justification has been provided throughout the certification process.

Medical device manufacturers must survey the supply chain to ensure they have up-to-date substance data for in-scope products. Assent’s EU MDR Module enables companies to collect the necessary supply chain data and identify substances present above threshold.

To learn more about how Assent’s powerful software can help companies collect and report on supply chain data for the EU MDR, contact info@assentcompliance.com.

Newsletter