Temporary EU Guidelines in Response to COVID-19

The Coronavirus pandemic has led to global supply bottlenecks for medical devices and Personal Protective Equipment (PPE). Throughout the past weeks, the European Union has taken measures to facilitate the supply of much-needed medical equipment. Here’s an overview of temporary EU guidelines with regards to compliance:

Postponement of the Medical Device Regulation until May 2021
The Medical Device Regulation (MDR) was set to come into force on the 26th of May. However, the MDR implementation date will be postponed by one year so that the health sector can prioritise the fight against the Coronavirus pandemic. The amendment is now published in the EU official journal, effectively pushing the date of application to 26 May 2021. 

Revised harmonised standards for faster conformity assessment procedures
Temporary harmonised standards have been adopted to facilitate faster and less expensive conformity assessment procedures. These standards apply to critical devices, including:

  • Medical face masks
  • Surgical drapes, gowns and suits
  • Washer-disinfectors
  • Sterilisation 

Free availability of EU harmonised standards
All relevant European harmonised standards are fully available for interested companies. Usually, such standards must be purchased and bear strict copyright restrictions, but the current agreement ensures free access for businesses in both EU and non-EU countries. Ensuring the availability of harmonised standards can expedite the manufacturing of medical equipment without compromising health and safety. 

Guidance to assist with the production of essential medical equipment
Additional guidance has been made available to assist manufacturers and market surveillance authorities in ensuring the production and safety of essential medical devices. The guidance is available in three areas:

  1. Personal protective equipment 
  2. Leave-on hand cleaners and hand disinfectants
  3. 3D printing of medical-related products

Export authorisations
Personal Protective Equipment (PPE) intended for sale outside the European Union is temporarily subject to export authorisation by Member States. Additionally, almost all Member States have lifted national export restrictions to ease the distribution of medical equipment within the EU. 

For a complete overview of medical device guidelines in response to COVID-19, click here.

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Certification Experts is an independent product compliance organization. With over 25 years’ experience, Certification Experts evolved in a hub of expertise and subsequently established a valuable track record. With offices based in the Netherlands, Germany and China, we offer tailored expertise for a wide range of subjects pertaining to the entire product safety spectrum.

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  • Certification Simplified

Certification Experts is an independent product compliance organization. With over 25 years’ experience, Certification Experts evolved in a hub of expertise and subsequently established a valuable track record. With offices based in the Netherlands, Germany and China, we offer tailored expertise for a wide range of subjects pertaining to the entire product safety spectrum.

We make the future safe.

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