Understanding the Changes of MDR in 2021
The advent of the new Medical Devices Regulation (MDR 2017/745) is a cause of much concern for manufacturers and others in the devices sector. The new regulations have brought about many changes compared to the previous regulatory framework. We look at the basics of the new MDR and the changes that have impacted the device sector from May 26th, 2021.
This article was first published in 2019. We have revised this article for a fresh outlook on the understanding of MDR since it’s introduction in May, 2021.
What is the MDR?
MDR (EU) 2017/745 repeals the existing medical device directives that were first put in place in 1993. The new regulation was published on May 5th, 2017 and came into force on May 26th, 2021.
Why did we move from MDD to MDR?
- The Medical Devices Directive (93/42/EEC) was in force for all members states of the EU (there are currently 27), the members of the European Economic Area (includes EU countries in addition to Iceland, Lichtenstein and Norway) and two countries with bilateral trade agreements with the EU (Switzerland and Turkey).
- Directives are transposed into national legislation by each Member State meaning that the directive was open to interpretation by each participating member state and subsequently, it was not implemented uniformly across all participating countries.
- Furthermore, the 1993 Directive has not kept pace with the changes in medical technology.
- Regulations are directly applicable in all Member States and do not require transposition into national law.
- The introduction of the new regulations ensure consistency and address developments in both device capability and technology.
- The scandals in Europe involving device manufacturers in recent years have also highlighted the requirement for a more robust regulation of medical devices.
What Are the Most Important Changes?
The new MDR represents a significant development in device regulation. Some of the main changes are highlighted below, however this list is not exhaustive.
- Product scope expansion to include products that do not have a medical purpose
- Enhanced roles of economic operators to include manufacturer, authorised representative, distributor and importer.
- Greater emphasis on “liability” – EU Authorised Representatives will be held jointly and severally liable for devices.
- Requirement for manufacturers to appoint a responsible person (RP) who is responsible for compliance with MDR
- More rigorous clinical evidence / clinical evaluation requirements
- Increased focus on post market surveillance
- An overhaul of EUDAMED, the European Electronic Database for Medical Device Information
- Introduction of UDI system – Unique Device Identifiers – to enhance traceability
The Increased Role of Clinical Data
Perhaps the most significant change from the MDD to the MDR is the increased focus on clinical evaluation, access to data and post market surveillance. This places a greater burden upon manufacturers and their representatives, and it is something that we, at Acorn Regulatory, have been helping our clients with.
The MDR only allows comparison under equivalence with one device. Using the equivalence approach to clinical evaluation will be much more difficult to achieve as manufacturers must have contracted access to the full technical documentation of the product with which they claim equivalence.
There is also an increased responsibility on manufacturers to document the effectiveness, safety, and quality of their own devices.
What Is The Definition of a Medical Device?
The MDR adopts a broader definition of “medical device.” The MDR now regulates invasive and implantable devices used for aesthetic and cosmetic purposes such as dermal fillers and coloured contact lenses. It is anticipated that such measures will increase both patient and user safety.
MDR is radically different in many respects. Whereas the MDD concentrated on the pre-marketing stage the MDR takes a holistic life-cycle approach and includes more topics such as Authorised Representation, the need for clinical evaluation and post-market clinical follow up which aligns closely with the US FDA approach.
How we can help
If you would like us to assist your company in this regard, then please complete the form below or contact us on 00353 52 61 76706.