Recent changes to the EU MDR
In the last year, there have been a number of changes to the EU MDR, not all related to the COVID-19 crisis. In October 2019, the launch of the European Databank for Medical Devices (EUDAMED), the database where manufacturers will need to register new medical devices entering the European market, was delayed by two years. Manufacturers of medical devices have an 18-month registration timeline following on from the full launch of the database – originally, this would have taken manufacturers up until 26th November 2021. With the delay to EUDAMED, this has now been pushed back to 18 months after publication of an official notice on EUDAMED functionality by the Official Journal of the European Union. It should be noted that devices might need to be registered sooner, if, for example, registration is obligatory in the case of serious incident and field safety corrective action reporting. One reason for the delay is that the responsibility for the EU MDR has moved from the Director General for Internal Market, Industry, Entrepreneurship and SMEs, to the Director General for Health and Food Safety – which has, in turn, caused administrative delays. Additionally, there have been some technical delays, as not all of the different modules linking to EUDAMED have been finalised as quickly as originally planned. Further to this, at the start of the COVID-19 crisis, the compliance date for the EU MDR was also delayed. In March 2020, the European Commission proposed that the regulation should be delayed by one year due to COVID-19 – this was confirmed in April 2020 – making the new deadline for compliance 26th May 2021.
How will the delay of the EU MDR affect medical device manufacturers?
The initial two year delay to EUDAMED wouldn’t have had a significant impact on medical device manufacturers – as all manufacturers would have still needed to have all the required documents, and the correct coding and tracking information for their products by the initial compliance date. It was only the registration of devices onto EUDAMED that was delayed. Up until April of this year, medical device manufacturers were working towards the initial compliance date of 26th May 2020, and would have been working to share data on new medical devices with national authorities, national governments, and health ministries. Pushing the compliance date back by a year to 26th May 2021 will give manufacturers more time to prepare for the legislation – while some companies may use the time to delay their preparations, we foresee that, given the current circumstances, the time will likely be used wisely.
This current COVID-19 situation demonstrates how important it is to have an overview of medical devices entering the European marketplace. There are many governments who do not have access to information concerning the medical devices placed in their markets, and in addition, they do not know the amounts. The current situation with face masks and PPE has shown us how difficult it is to ensure stock of devices when governments do not have this visibility.Volker Watzke – EU Medical Devices Sector Manager
The current situation clearly shows how important the EU MDR regulation is, and it seems likely that the new timescales will stay in place, with no further delays to the regulation predicted after the COVID-19 pandemic.
Of course, this all depends on how long the COVID-19 crisis continues to have an influence on European markets. While it could cause further delays, I think that the one-year delay has been announced to give manufacturers a better focus on dealing with the current situation, and I do not predict another postponement.Volker Watzke – EU Medical Devices Sector Manager
Flexible production in the face of COVID-19
In recent months, there has been an increase in demand for and manufacture of certain medical devices, including personal protective equipment (PPE), owing to the current COVID-19 situation. Across Europe, and indeed the world, many companies that were not manufacturing medical devices prior to COVID-19 have now entered the marketplace with disposable masks and PPE to satisfy a dramatic increase in demand.
It is important for these manufacturers to ensure that what they are manufacturing is actually fit for purpose, particularly with PPE. It needs to be to the right standard. And it is also extremely important that it is marked correctly as well, not just with the right CE mark and the right grade, but also making sure that they’re using an ink that’s not toxic.Craig Stobie – Director of Global Sector Management
Once the EU MDR comes into effect, all such face masks will fall under the classification of Class 1 medical devices (devices which pose a low or moderate risk to patients) and will require coding in line with the EU MDR. Though facemasks currently produced in Europe do not need to adhere to EU MDR regulations, they do still require coding in line with European products safety standards and regulations.
There are a number of different requirements for the manufacture of face masks, depending on the type of mask. Some of these masks are surgical masks which are N95 rated – while others are being produced by people in their homes. There are a number of companies currently producing masks which may not fall under any current medical device regulations which will still require coding in terms of a CE mark or batch code.Bart Vansteenkiste – Global Life Sciences Sector Manager
New players entering the medical device market have a lot to consider when it comes to coding their products – not only in ensuring that the resulting code adheres to all current legislation, but also that the coding method is suitable to the type of device being produced. For face masks and PPE, the overall durability, longevity, and toxicological makeup of different ink types must be considered when selecting an appropriate coding solution.
Ensuring the right ink for your product
Ultimately, the responsibility for any product placed into the marketplace lies with the manufacturer, however, it is important for manufacturers to enlist the support of a coding and marking supplier to determine the correct approach to take when coding new products such as facemasks.
We can support those companies who are producing these products for the first time, with sector-specialised inks which are safe to use on face masks and PPE – including inks that comply with EuPIA standards, that do not contain any products which may be irritating to skin.Volker Watzke – EU Medical Devices Sector Manager
Determining the right choice of ink is key for producers of medical devices during the current climate – whether they are new to the market or not. This is a significant aspect of the support that Domino provides to medical device manufacturers. Throughout the COVID-19 crisis, Domino employees around the world have been supporting customers, and are currently engaged in carrying out further testing in coding and marking on face masks and PPE.
We want to give our customers and medical device companies a holistic approach to determining the correct ink for their product. This means, not only focusing on inks and how they appear on the substrate, but also educating substrate providers on the reaction of certain consumables, such as inks and ribbons, on their product.Volker Watzke – EU Medical Devices Sector Manager
Medical device categorisation under the EU MDR
In December 2019, the second corrigendum of the MDR, published by the European Council, granted additional compliance time for manufacturers of certain Class I medical devices, and Class 2 and 3 medical devices which were previously classified as Class 1 under the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD).
When we focus on most Class 1 products, manufacturers need to comply to the regulation and ensure that they do the same data collection as manufacturers of Class 2 and Class 3 products. Manufacturers of General Class 1 products still need to register their devices on EUDAMED, however they do not need to have their products certified by a Notified Body.Volker Watzke – EU Medical Devices Sector Manager
However, manufacturers who have had their devices up-classified to Class 2 or 3 under the new EU MDR, as well as those manufacturing items classified as reusable (Class 1r), sterile (Class 1s), or those with a measurement function (Class 1m) are subject to stricter regulations, and must ensure their devices are registered on EUDAMED, and certified by a Notified Body. The new extension applies only to devices which have been up classified under the EU MDR as higher risk, and grants manufacturers an additional compliance time – with a deadline for sharing data on EUDAMED, and certification by a Notified Body of 26th May 2024.
Steps to compliance
There are several steps that manufacturers of Class 1 medical devices should go through to ensure that compliance with the EU MDR is as quick, and easy as possible. A new document published by the Medical Device Coordination Group in late 2019, Guidance Notes for Manufacturers of Class 1 Medical Devices, provides a checklist to guide medical devices manufacturers through the process of becoming compliant – a summary of which is given below.
- Check and confirm that the product is a medical device
- Confirm which product class the medical device falls under
- Ensure that the general safety and performance requirements of the EU MDR have been met
- Perform the clinical evaluation and prepare for the technical documentation
- Request involvement of a Notified Body, if necessary
- Prepare instructions for labelling
- Check compliance with general obligations for manufacturers
- Check compliance with the EU Declaration of Conformity and Ethics
- Verify product CE marking and ensure compliance
- Register devices in EUDAMED and share with national authorities
- Collect and evaluate post-market data and share with the vigilance system
Finding a Notified Body
With the initial compliance deadline for the EU MDR now long passed, it may come as surprise to read that manufacturers are still struggling with a lack of certified Notified Bodies available to help register their products and receive their certificates for compliance. Under the previous Medical Devices Directive, there were 57 Notified Bodies, both in Europe and beyond, supporting medical device manufacturers to help get their products to market. However, all Notified Bodies wishing to operate under the EU MDR are required to be audited and designated again in line with the new regulations. Most of them are still going through the process of being audited and have not been designated by the EU authorities yet. At the time of writing, only 15 Notified Bodies have reached full designation under the EU MDR.
This is a problem for medical devices manufacturers. They do not know who to speak to for now – any certification that they get from a Notified Body which is not yet accredited will not be accepted by the EU authorities.Volker Watzke – EU Medical Devices Sector Manager
Of the 57 Notified Bodies who were accredited under the previous regulation, approximately 40 have applied for designation under the EU MDR – suggesting that several Notified Bodies have made the decision to stop supporting medical device manufacturers under the new directive.
This means that some manufacturers now have to change their Notified Body which they may have been speaking to for years and may no longer be able to find a Notified Body in their country. It’s of interest to speed up this situation and ensure that Notified Bodies can be audited and designated as quickly as possible.Volker Watzke – EU Medical Devices Sector Manager
However, with the current COVID-19 crisis, the process of auditing new Notified Bodies has been put on hold, so it is likely that this will continue to be an issue for manufacturers in the coming months. An up-to-date list of all designated Notified Bodies can be found on the European Commission website.
We’ve talked a lot about EU MDR so far in the blog – let’s turn now to other regions to discuss whether similar trends can be seen outside of Europe.
I don’t think it’s a good idea for manufacturers to start out in different regions. The most beneficial areas of the world in term of commercialisation are the US and the EU, which are already under regulation. To start in different regions of the world would mean to focus on one of the countries within the G20 which are already discussing regulations.Volker Watzke – EU Medical Devices Sector Manager
For medical device manufacturers who are just starting out, ensuring products comply with the EU MDR may seem like a lot of work, however, it’s unlikely that this in itself would be a barrier to innovation in EU, or that start-ups would choose regions other that the EU to begin commercialisation of their products.
Looking to the remainder of 2020, I do not expect any major changes from manufacturers out of the UK – going forward they will probably be handled in a similar manner to other manufacturers from outside the EU.Volker Watzke – EU Medical Devices Sector Manager
At present, those companies operating in countries outside the EU, including Switzerland, and the US, who need to comply with the EU MDR must have an EC Rep – an authorised representative under the EU MDR. The EC Rep provides a legal point of contact between non-European medical device manufacturers and EU authorities, Notified Bodies, and EUDAMED.
The cost of compliance
Compliance with regulations is not only challenging logistically, it can also be expensive. In a previous blog, we discussed the overall cost of compliance with the EU Falsified Medicines Directive (EuFMD) – which includes adjusting production environments for item-level serialisation. The total cost for compliance was found to be between €100K for smaller manufacturers and €250K for mid to large-sized firms – a significant expenditure. Can the same cost be expected from compliance with the EU MDR?
I think they are more manageable than for the EU FMD simply because of the fact that only in a very few cases serialisation will be involved. It is a different story and a different picture. I think the difference could be ten times less expensive to become compliant with EU MDR than it would be to become compliant with EuFMD.Bart Vansteenkiste – Global Life Sciences Sector Manager.