COVID-19 Alarm State
Certification for PPE & Medical Devices during COVID-19 Health Alert
Due to the health alert caused by the Coronavirus COVID-19, exceptional measures have been put in place for the acceptance of Personal Protective Equipment (PPE), such as masks for respiratory protection (respirators), protective clothing, eye and face protection and protective gloves; and Medical Devices (MD) such as surgical gloves, gowns and masks.
The European Commission published on March 13, 2020 in the Official Journal of the EU the Recommendation (EU) 2020/403 regarding the CE Marking, certification, conformity assessment and market surveillance procedures in the context of the threat posed by COVID- 19 where it invites all economic operators throughout the supply chain, as well as notified bodies and market surveillance authorities, to put in place all the measures at their disposal to support efforts to ensure the supply of PPE and medical devices across the EU market matches the increasing demand.
Recomendation (EU) 2020/403 of 13 March 220
1. With the objective to ensure availability of PPE and medical devices for adequate protection in the COVID-19 outbreak, the Commission invites all economic operators throughout the supply chain, as well as notified bodies and market surveillance authorities to deploy all the measures at their disposal to support the efforts aimed at ensuring that the supply of PPE and medical devices throughout the EU market will match the continuously increasing demand. Such measures should nevertheless not have a detrimental effect on the overall level of health and safety and all relevant stakeholders should ensure that any PPE or medical devices, which is being placed on the EU market, continues to provide an adequate level of protection of the users’ health and safety.
Certification of PPE
Personal Protective Equipment (PPE) must be in accordance with Regulation (EU) 2016/425 on Personal Protective Equipment. This implies that the manufacturer must prepare a EU Declaration of Conformity. In addition, the PPE must include the information indicated in the Regulation: manufacturer data, product identification (batch number…), instructions and information, etc. PPE may be Category I, II or III, depending on the level of risk protection for which they have been designed.
Certification of Medical Devices
Medical Devices must be in accordance with Council Directive 93/42 / EEC on Medical Devices. From May 26, 2020, Regulation (EU) 2017/745 of the European Parliament and the Council on medical devices apply.
As for the case of PPE, manufacturers of MD must prepare a Declaration of conformity and the product must be accompanied by the information requested in the legislation mentioned.
Product certification during COVID-19 Health Alert
Due to the current situation and the worldwide increase of demand for products aimed at protecting against the COVID-19 virus transmission , Sherpa Product Certification has dedicated an exclusive department to serve requests related to personal protection equipment (PPE) and medical devices (MD).
If you need assistance, please, fill in the form and we will contact you as soon as possible.
How can we help?
Sherpa Product Certification is formed by a group of engineers who are experts in regulation and standardization of products, materials and industrial processes at an international level. Our essence as Sherpas is to help our clients to create lasting value in their business and meet their professional needs. If you need help in the procedures of a certificate or simply need specific information about our services, we are happy to help you. Hire a Sherpa in your company and forget about legislation and documentation of your products. Our Sherpas certification experts report quickly and efficiently to the needs of our clients when we are most needed.