FAQ on BPR
What products will BPR regulate?
BPR regulates the approval of biocidal products. In a two-stage process, first the active ingredients are approved and then the biocidal product as such.
Will there be delays in delivering products like Sterillium Protect & Care?
No. HARTMANN has already submitted the dossiers for the first product families to the approval authorities and expects the approval process and certification to be completed smoothly.
FAQ on IVDR
How will the approval process for in vitro diagnostic devices change?
IVDR introduces a new classification system with risk classes A to D. Class A classifies products with the lowest level of risk, such as general laboratory supplies like test tubes or tubing, and Class D classifies products with the highest level of risk. Furthermore, the Notified Body will be more involved in the approval process of in vitro diagnostic devices. It is expected that in the future it will no longer test only 15 percent of the products, but up to 90 percent.
How will customers be able to trace if a product is IVDR compliant?
Similar to the MDR, the IVDR will also introduce a new Unique Device Identification (UDI) system, which will make it easier to trace products through the supply change. Additionally, stricter rules apply to technical documentation and clinical evaluation with the new IVDR.
FAQ on MDR
Does HARTMANN have a Notified Body accredited under MDR?
Yes. We partner directly with TÜV SÜD.
Do you know whether you will still be supplied with all the products you have used up to now after May 2021?
With the end of the transition periods, all medical devices must be compliant with the MDR. The only exceptions are products that are already in the trade chain and may be sold and used from warehouses until 2024.
What about products that are already in the “chain of commerce”?
These product may still be given to customers after the new deadline in May 2021, but at most until May 2025. Dealers may return such products to the manufacturers in 2024!
How can I tell if a supplier is "MDR compliant" or not?
You can't tell by looking at the supplier. There is no sticker or badge for suppliers that confirms compliance. However, there are indicators, such as the MD symbol and the 8-digit date on the date of manufacture.
How can I recognize if the medical device is MDR compliant?
Look for the MD symbol or check the manufacturer or supplier website.
How do I safeguard myself with my suppliers?
Ask whether the manufacturer has an MDR declaration of conformity for the corresponding product family. For higher class products, the supplier or legal manufacturer must have an ISO 13485 certificate or a product test from a Notified Body.
You can also see if the manufacturer has a certificate on the page of the respective Notified Body. For example, HARTMANN partners directly with TÜV SÜD.
This will be made easier with the introduction of the UDI. Healthcare facilities are exempt from the obligation to show declarations of conformity from all their suppliers. BUT: It should still be checked whether suppliers comply with guidelines. For example, in some countries, incorrect labels (such as for CE marking) are deliberately applied.
Where can I procure MDR compliant products?
Contact our HARTMANN team and we will help you find the MDR compliant products you need as quickly as possible.
Do declarations of conformity really have to be kept of every single medical device used in practice?
The MDR allows for random inspections for distributors (Article 14, paragraph 2), in which the CE marking, the declaration of conformity, and the Basic UDI must be verified. We recommend that, particularly in the transitional period, appropriate checks be carried out as part of the duty of care and that this be documented accordingly.
How will MDR influence business areas in the UK?
HARTMANN’s business areas in the UK are very limited. We do not manufacture products in the UK. For certificates that are also effective in the UK, HARTMANN works with Notified Bodies in the EU, e.g. TÜV SÜD (Germany) and SATRA (Ireland). We will register all products that are sold in the UK according to local requirements.
Has Brexit exerted additional pressure on supply chains in light of MDR?
HARTMANN only sources selected traded goods and raw materials from the UK and has taken appropriate steps to ensure the continuity of its supply chains. This includes, for example, increased stock levels. All measures taken have resulted from a comprehensive risk analysis of HARTMANN and its suppliers.
How will MDR affect business with Switzerland?
MDR covers the EU market, which of course doesn’t include Switzerland. However, as HARTMANN continues to do business with Switzerland, in terms of customers and suppliers, there will be a continued need for coordination. HARTMANN did already pro-actively close contracts between HARTMANN entities PHAG and IVF to ensure the role of EU Representative and respectively CH Representative. We are cooperating with Swiss trade associations to receive first-hand information regarding the transitional provisions. Currently, we are preparing the labeling of products and the registration of products in the EUDAMED and SwissMedic databases. As we have our own subsidiary in Switzerland, we are confident we will be able to ensure future supply from and into Switzerland.
Have another question?
You didn’t find the answer to your question? Then please, ask away! Use our contact form to send us your question, and we’ll be in touch.