1. 3M Medical Device Regulation
3M Health Care
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Medical Device Regulation

Guiding you through MDR

3M is ready for regulation requirements with newly-revised product classifications*, packaging and labelling.

So relax, it’s business as usual.
 

*Where applicable

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Business as usual

Our teams are fully prepared, ready to ensure your product supply is not interrupted during the transition.


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Same innovative products

Our class-leading and reliable products are still among the very best you can buy.


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Everything is covered

3M has certified its respective product groups under MDR, so you can relax knowing everything is taken care of.


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FAQ

Below we have summarized the answers on the most frequently asked questions to answer your inquiry related to readiness of 3M to fulfill the requirements laid out in Regulation (EU) 2017/745 (MDR). The information provided relates to 3M subsidiaries and products under 3Ms regulatory responsibility. Consequently they are not necessarily identical to information provided by other meical device manufacturers. This catalogue of questions and answers is frequently updated to reflect latest development around MDR knowledge.

  • What is the status related to the transition of 3M devices from MDD* to MDR? *(93/42/EEC Medical Device Directive)
    Since publication of the MDR in 2017, 3M is preparing for implementing MDR requirements. After an in depth gap analysis, multiple teams of concerned functions are now working on detailed implementation plans. As a globally acting company, different roles have to be taken into consideration (e.g. manufacturer (inside and outside the EU), authorised representative (EC REP), importer). For these roles, plans are developed and now being implamented in the affected subsidiaries. We are confident that we can supply our customers at any time with CE marked products which are in compliance with the current regulatory framework at the time of supply. With 3M, you're on the safe side. (for details please also refer o Q6/A6).
  • 3M is planning to certify all product groups under MDR. (see also Q3/A3).
  • As a result of ongoing portfolio management, some devices will be taken off the market due to econimic reasons. We will inform affected customers in due course and offer funtional equivalent devices.
  • The classification of products in the "Medical Solutions Division" (Medical) will not change.Some products of the "Oral Care Solutions Division" (Dental) are being upclassified.
  • 3M companies will continue to cooperate with the established Notified Bodies. In concrete terms, these are:
    For 3M Deutschland GmbH (Manufacturer & EC REP) these are for the Medical products of "Medical Solutions Division" DQS Med (CE0297) and for
    Dental products of "Oral Care Solutions Division" TÜV SÜD PRODUCT SERVICE GmbH (CE 0123).
    For 3M Company, USA (Manufacturer) it is BSI UK (CE0086) resp. BSI The Netherlands (CE2797) because of upcoming Brexit
    The regulatory responsibility for products from 3M Poland Manufacturing Sp. z. o o. (Manufacturer) will pass to 3M Deutschland GmbH.
  • 3M has a teams that are working working to ensure the product supply is not interrupted during the transition. However, there are external factures which are not within 3M’s control, e.g., Notified Body Designation to MDR. Because of this, 3M is unable to guarantee continuous supply but we will do everything within our control to make sure there are no supply interruptions.
  • There is no general answer to this question due to multiple reasons.
    For Class I products (self-certification): The production changeover to CE-marked products according to MDR will take place per production line in order to keep the environmental impact and costs for e.g. the destruction of packaging materials as low as possible. In addition, the MDR allows products lawfully placed on the market before 26 May 2020 in accordance with MDD (93/42/EEC) to continue to be made available until 27 May 2025 (see Art. 120 (4) MDR). Products stored in a 3M or customer warehouse within the EU on 25 May 2020 will therefore continue to be marketable, i.e. they can be traded and used.
    For products of Class I and higher, as well as products of Class I which are upclassified under MDR (certification by the Notified Body): Certification of these devices is only possible in cooperation with the Notified Body. Therefore manufacturers are dependent on the capacities of the Notified Body. The Notified Bodies must be newly designated by the EU Commission for certification under MDR. This process is still in progress for most Notified Bodies (status Feb 2020). Therefore it is currently not foreseeable at which time the Notified Bodies can audit which companies and products. For the affected product groups (Class Is and higher), however, there is a much longer transitional period for the granting of the necessary EC certificates (until 26 May 2024 at the latest), which is why these may also be produced and placed on the market according to valid EC certificates under MDD after 26 May 2020 (see Art. 120 (2)ff MDR).
  • Products formally "first placed on the market" according to the MDD by 25 May 2020 can continue to be made available (traded) and used after this date. This so-called "warehousing clause" is intended to prevent good products from being discarded on a specific date. Due to the supply chain used by 3M, all products stored in a 3M warehouse (or a customer's warehouse) on 25 May 2020 are to be regarded as "placed on the market" and are subject to this rule. Both 3M and its customers can therefore distribute and/or use these products without hesitation. The "absolute deadline" is the product's expiry date or latest 26 May 2024, after which products manufactured under MDD are no longer approved. (please also refer to Q/A7).
  • The appointment of one or more PRRC's will take place in time for the entry into force of the MDR. These persons will be registered in EUDAMED according to the legal requirements. Also possible future changes of the responsible person(s). According to the current state of knowledge, EUDAMED will be publicly accessible in this area, making this information available to the general public. Due to the large number of our business partners, we are unfortunately unable to provide active notification of changes to the PRRC(s).
  • For Class I devices, the preparation for MDR compliance is proceeding as planned according to the May 26, 2020 deadline. For those devices we do not foresee any impact on MDR compliance due to the Corona phase.
    We are continuing our ongoing efforts to prepare higher class devices to become MDR compliant according to currently published MDR timelines. However, the development of the Corona situation is unpredictable, from availability of designated Notified Bodies (see also Q/A7) to the evolving proposal about delaying the date of MDR application.
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  • What will be the impact on 3M's devices due to the potential delay of the MDR?
    The EU Commission has made a proposal to delay the date of application of the MDR for one year. This proposal is pending ratification from the EU Council and EU Parliament. There is no deviation from the timeline for MDR compliance expected for 3M´s Class I devices (see Q/A10). With respect to higher class devices see Q/A6 & 7.
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