On a regulatory level the EU allows important devices to be placed on the EU market without the CE mark relevant for the fighting of the COVID-19 crisis. Those are Products covered by Regulation (EU) 2016/425 on personal protective equipment (PPE) and medical devices covered by the Directive 93/42/EEC (MDD) or Regulation (EU) 2017/745 (MDR).
Certain PPE and medical devices are disparately needed to fight the Covid-19 crisis. The CE mark has to be put on those products in order to place them on the market in Europe. It may be noted that certain products may have to comply to both regulations since both have a different objective. Face mask or gloves protects the patient (medical device) and protect the user (PPE).
The PPE requirement for these types of product understandably are of the highest risk category and therefore may need to involve a notified body to achieve the CE mark. The medical devices are of a lower risk class and may be placed on the market and a notified body does not need to be involved.
With the Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat now allows the placing on the market of these products without the CE Mark. But only with a full evaluation (approval) of a market surveillance authority.
- Notified Bodies (NB) under Regulation (EU) 2016/425 should prioritize the assessment if they apply the CE marking.
- Other technical solutions like for example the WHO recommendations may also be considered by the NBs.
- For medical devices the reference to the Article 11 (3) MDD and Article 59 MDR is being made for member states to allow for derogation form the conformity assessment. Should a product not fully comply the Authority may apply this compliance route.
- Certainly, only for the duration of this crisis.
- Only for the healthcare workers and not for the general public.
Please find the recommendation here.
This important initiative of the EU, allows others to produce these highly needed devices like for example the clothing industry in terms of the face masks.
In addition, important standards have been harmonized (see here) and certain standards are now freely available for those manufacturers (see here).