Helena Dzojic, Head of Medical Devices at the Swedish Medical Products Agency (MPA), answers questions about new EU regulations in medical device sector.
What general changes do the new regulations mean?
The new regulations apply from 2020. Basically, they involve no major changes: CE marking is still required and high-risk products are still to be assessed by Notified Bodies, for instance. But certain new clarifications and increased responsibilities have been included. For example, regulations now apply to players with commercial interests (e.g. importers and distributors), more product groups have been added (e.g. aesthetic products), some products have a new classification (software, drug-related products, etc.), traceability requirements via UDI (Unique Device Identification) are now in place, and the requirements for clinical data have been strengthened.
How do they affect work at the MPA?
The increased demands on commercial players also put greater demands on us as a supervisory agency. Initially, it requires a lot of work to interpret the new rules and write guidance documents that will facilitate the work of these operators. Therefore, the MPA has increased its participation in EU working groups and will now allocate up to five full-time positions for this work. This can be compared with that we usually devote slightly more than one full-time position to EU work. Furthermore, we have also been assigned new responsibilities for Notified Bodies. According to the new regulations, we are mainly responsible for Swedish Notified Bodies in medical devices, but we also participate in reviewing Notified Bodies in other member countries. Ensuring that these organisations have the competence to work according to the regulations is very important and we have therefore allocated extra resources for this goal and are making a greater contribution than previously. The sooner we have Notified Bodies in place, the faster manufacturers can get their products CE marked according to the new regulations.
What does this mean for Swedish medical device companies?
Swedish companies will be affected differently depending on the type of products in their portfolio. Certain software-based devices that do not currently need assessing by a Notified Body will now require this. The same applies to certain drug-related products and, in particular, products for in vitro diagnostics. If your company has not previously had contact with Notified Bodies, this will mean a new way of working, as well as increased costs.
Any ‘insider’ tips for these companies?
Since the basics of CE marking remain, it’s a good idea to keep track of the rules that apply today. I know that some companies have not acquainted themselves with current regulations and they thus have a longer ‘get-up-and-running’ time than those who are up to date. If you already think that medical device EU directives are complicated, I recommend that you update your understanding. Then you should look at the products in your portfolio and see which, if any, are affected by the new EU regulations, such as the requirement for a Notified Body, for example.
What’s the current situation with the Notified Bodies?
Procedures to ensure that we have Notified Bodies that can receive and certify MDR (Medical DevicesRegulation) products are being drawn up. One of the effects that the increased requirements will have on Notified Bodies is the need to recruit more staff. They may also incur increased costs due to the audit that authorities must now carry out. How all of this affects manufacturers remains to be seen. The reviews of Notified Bodies carried out jointly by the EU Commission and the responsible authorities are currently going according to plan since authorities have allocated more experts to the reviews than was first envisaged. The MPA is one of the authorities that has allocated more experts than normal. The reason for this is that we regard access to Notified Bodies as an essential part of implementing the new regulations, and that via these extra resources we contribute to increased patient safety.
Helena Dzojic, Head of MPA
Fact box - What are ‘Notified Bodies’?|
Notified Bodies are independent organisations with the expertise to assist and monitor manufacturers’ efforts to verify that the products they bring to market comply with the regulations applicable in the European Community.
In Sweden, Notified Bodies are appointed and / or accredited according to EU directives by Sweden’s national accreditation body Swedac. However, Notified Bodies according new EU regulations (MDR/IVDR) are appointed by Swedish Medical Products Agency. Within the EU, the appointing authorities collaborate within the NBOG (Notified Body Organisations Group), which publishes guidelines in the area.
Source: Swedish Medical Products Agency