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.
COVID-19
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.
- The notified bodies under Regulation (EU) 2016/425 should prioritise and swiftly conduct the conformity assessment activities in the framework of all newly submitted requests by economic operators of PPE necessary for protection in the context of the COVID-19 outbreak.
- In the case of PPE products manufactured following technical solutions other than harmonised standards, the WHO recommendations on the appropriate selection of PPE may be used as a potential source of reference for such technical solutions, provided that the said technical solutions ensure an adequate level of protection corresponding to the applicable essential health and safety requirements laid down in Regulation (EU) 2016/425.
- Notified bodies which issue certificates to PPE products manufactured following other technical solutions than harmonised standards, should immediately inform the relevant notifying authority as well as the other notified bodies under Regulation (EU) 2016/425 of the certificates issued and the specific technical solution followed. Notified bodies should exchange such information through the coordination of notified bodies group established under Article 36 of Regulation (EU) 2016/425.
- In the case of medical devices, the possibility for Member States to authorise derogations from conformity assessment procedures should also be considered, according to Article 11(13) of Directive 93/42/EEC and Article 59 of Regulation (EU) 2017/745 once the latter becomes applicable, also when the intervention of a notified body is not required.
6. The relevant market surveillance authorities in the Member States should as a matter of priority focus on non-compliant PPE or medical devices raising serious risks as to the health and safety of their intended users.
7. Where market surveillance authorities find that PPE or medical devices ensure an adequate level of health and safety in accordance with the essential requirements laid down in Regulation (EU) 2016/425 or the requirements of Directive 93/42/EEC or Regulation (EU) 2017/745, even though the conformity assessment procedures, including the affixing of CE marking have not been fully finalised according to the harmonised rules, they may authorise the making available of these products on the Union market for a limited period of time and while the necessary procedures are being carried out.
8. PPE or medical devices not bearing the CE marking could also be assessed and part of a purchase organised by the relevant Member State authorities provided that is ensured that such products are only available for the healthcare workers for the duration of the current health crisis and that they are not entering the regular distribution channels and made available to other users. L 79 I/4 EN Official Journal of the European Union 16.3.2020 9. Market surveillance.
9.Market surveillance authorities should inform immediately the Commission and other Member States of any temporary arrangement they have granted to specific PPE or medical devices. For PPE, this should be done through the Information and Communication System for Market Surveillance (ICSMS).
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.
Personal Protective Equipment (PPE)
Directive 2016/425/EU harmonizes health and safety requirements for the use of personal protective equipment that protects users.
Medical Devices (MD)
Regulation 2017/745/EU & Directive MDD 93/42/EEC harmonise manufacturing standards and requirements established by the European Union for manufacturing medical devices.
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.
PRIORITARY REQUEST
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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?
- Certification of Medical device & PPE
- Orientation & Advisement
- Verification of Certificates & documentation
- Worldwide Laboratory Tests
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