After years of delays and transition periods, the Medical Device Regulation (MDR) for Class I products has now come into force.
Examination gloves can generally be assigned to Class I (unsterile gloves) or Is (sterile gloves).
Since no notified body has to be involved in issuing the declaration of conformity for class I products, there are no longer any transition periods and only class I gloves according to MDR may be imported and placed on the market.
Class I products, which correspond to (EC) 93/42 / EEC and are already in the community, may be sold until April 26th, 2024 at the latest (provided the declaration of conformity is still valid until then).
Class Is products can also be sold until May 26th, 2024 if they have a valid MDD certificate.
(non-sterile products)
Since May 26, 2021, these products may only be placed on the market in accordance with the MDR regulations
(sterile products)
A transition period still applies here: With a valid MDD certificate, these products can still be sold until May 26, 2024
Depending on the validity of the MDD certificate
A transition period still applies here: With a valid MDD certificate, these products can still be sold until May 26, 2024
Depending on the validity of the MDD certificate
and will be placed on the EU market after May 26th, 2021
May no longer be imported and placed on the market
and are already in the community
May be sold and put into operation until May 26th, 2024
and are already in the community
May be sold and put into operation until May 26th, 2024
and will only be placed on the EU market after May 26th, 2021
May be sold and put into operation until May 26th, 2024
As a rule, this can only be recognized from the declaration of conformity or the corresponding marking on the product packaging.
This distinction is by far not as important for end users as it is for dealers and importers, as they have to make sure according to the MDR that the products they sell comply with the applicable standards and regulations.
Infinitymed Gloves comply with the current MDR 2017/745 for medical devices as well as the PPE (EU) 2016/45 for personal protective equipment and (EU) 1935/2004 for objects that come into contact with food
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