Guiding you through Medical Device Regulation

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

So relax, it’s business as usual.

*Where applicable

Business as usual

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

Same innovative products

Our world-leading technologies are among the very best you can buy.

Everything is covered

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

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 3M's 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 to Q6/A6)
Which products will be certified according to MDR?
3M is planning to certify all product groups under MDR. (see also Q3/A3).
Will there be products not being certified according to MDR/ taken off the market?
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.
Is the risk classification of products changing from MDD to MDR? If so, for which products?
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.
Will the Notified Body change?
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 Brexit and TÜV SÜD.
The regulatory responsibility for products from 3M Poland Manufacturing Sp. z. o o. (Manufacturer) will pass to 3M Deutschland GmbH
Are supply bottlenecks due to MDR implementation to be expected?
3M has teams that are working to ensure the product supply is not interrupted during the transition. However, there are external factors 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.
When will MDR certified products be shipped?
For class I products (self-certification): The production changeover to CE-marked products in accordance with MDR began in April 2020. Regulation
(EU) 2020/561 postponed the start of application of the MDR in Article 120 MDR by one year. The original schedule has been retained for the majority of 3M's Medical Devices. Implementation of MDR compliant products into production took place for the majority of products last year and will be finalized until April 2021. However, due to the existing storage quantities, it is not possible to give exact shipping dates for MDR compliant devices. Since the marketability of the MDD-certified products remains until 26 May 2024, all products can continue to be sold and used.
For products of class Is and higher, as well as for products of class I that are up-classified under MDR (certification by the Notified Body):
Here certification is only possible in cooperation with the notified body. Therefore the manufacturers are dependent upon the capacities of the Notified Body. The Notified Bodies must be designated by the EU Commission for certification under MDR. All Notified Bodies cooperating with 3M have successfully completed the certification process according to MDR. The planning for certification according to MDR has started, but no exact dates can be given currently as to when the products will be certified by the Notified Bodies. However, for the affected product groups (class Is and higher), there is a significantly longer transition period for the issuing of the necessary EC certificates (up to 26 May 2024 the latest). Therefore, products certified under MDD before 26 May 2021 can continue to be first made available under a valid MDD certificate until 26 May 2024 (see Art. 120 (2) ff MDR).
What happens to products certified under MDD after May 26, 2021?
Products formally "first placed on the market" according to the MDD by 25 May 2021 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 2021 are to be regarded as "first 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 cannot be first placed on the market or put into service. (please also refer to Q/A7).
Who is the PRRC - Person Responsible for Regulatory Compliance - and how are we informed about the change in this position?
Margaret Bessenbach, Manager Regulatory Affairs & Quality, Health Care Business EMEA is appointd PRRC of 3M Deutschland GmbH.
This will be registered in EUDAMED according to the legal requirements once EUDAMED is available. Also possible future changes of the responsible person(s) will be registered accordingly. To the current state of knowledge, PRRC information in EUDAMED will be publicly accessible, 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).
Are you expecting issues in MDR readiness and/or supply due to the coronavirus/Covid-19 pandemic?
For Class I products, the activities to switch to MDR continued as originally planned and have largely been completed. We do not see any effects for these products due to the Covid-19 pandemic.
Whether there will be any impact on the transition of higher class devices will depend on future developments in relation to the pandemic. The preparations on our part continue unabated. We therefore assume that the MDR certification will be completed well before the end of the transition period.