Understanding MDR: 8 Important Changes

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 will bring about many changes compared to the current regulatory framework.  We look at the basics of the new MDR and the changes that will impact the device sector from May 26th, 2020. Update: You will see that some of our comprehensive MDR content that we have created refers to the May 2020 date of application.  The date of MDR application has moved to May 26th, 2021.  Articles that were written prior to the delay referenced the earlier date.  However, articles that you might read that reference the earlier date should be read taking the new date of May 2021 into consideration.  Read more here.

What is the MDR?

Medical Devices Regulation (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 will come into force on May 26th, 2020.

Why Are We Moving from MDD to MDR?

• The Medical Devices Directive (93/42/EEC) was in force for all members states of the EU (there are currently 28 including the UK), the members of the European Economic Area (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 and this meant that the directive was open to interpretation by each participating member state and, as such, it was not uniformly implemented across all participating countries.
• Furthermore, the 1993 Directive has not kept pace with the seismic changes in medical technology.
• Regulations are directly applicable in all Member States and do not require transposition into national law.
• The new regulations have been introduced to enforce uniformity and to address the developments in device capability and technology.
• The scandals in Europe involving device manufacturers in recent years have also added to the need for a more robust regulation of medical devices.

What Are the Most Important Changes?

The new MDR presents a significant development in device regulation.  Some of the main changes affecting manufacturers are highlighted below, but this list is not exhaustive.

1. Product scope expansion to include products that do not have a medical purpose
2. Enhanced roles of economic operators to include manufacturer, authorised representative, distributor and importer.
3. The issue of liability is much enhanced in the new regulations.  EU Authorised Representatives will be held jointly and severally liable for devices.
4. Requirement for manufacturers to appoint a responsible person (RP) who is responsible for compliance with MDR
5. More rigorous clinical evidence / clinical evaluation requirements
6. Increased focus on post market surveillance
7. An overhaul of Eudamed, the European electronic database for medical device information
8. 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 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 will have a broader scope as to what is classed as a device.  In particular, the MDR will regulate invasive and implantable devices used for aesthetic and cosmetic purposes such as dermal fillers and coloured contact lenses.  Again, the reasoning for doing so has been attributed to increasing patient and user safety. MDR is radically different in many respects.  Whereas the MDD looked at the pre-marketing stage, the MDR will take a more holistic life-cycle approach and include issues such as Authorised Representation, the need for clinical evaluation and post-market clinical follow up.  This is more closely aligned with the approach taken by the US FDA. Finally, this will signal a shift in how manufacturers and their representatives manage their devices.  We, at Acorn Regulatory, will keep our clients and visitors to our site informed of issues relating to the new regulations as May 2020 approaches. 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. We have further MDR articles and whitepapers available for you below the form. [ninja_form id=1]

Additional MDR resources

EU MDR: What Will The Impact Be For Economic Operators? Two new EU Regulations entered into force on 26^th May 2017. Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in-vitro diagnostics (IVDR) replace the current three Directives, which have been in place since the early 1990s. There is a transition period for the implementation of the various elements of the new regulations, with MDR becoming fully operational in May 2020 the IVDR in May 2022. Read the article here. What You Need To Know About the EU MDR & The Authorised Representative Two new EU Regulations entered into force on 26^th May 2017. Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in-vitro diagnostics (IVDR) replace the current three Directives, which have been in place since the early 1990s. There is a transition period for the implementation of the various elements of the new regulations, with MDR becoming fully operational in May 2020 the IVDR in May 2022. Read the article here. Get The Acorn Regulatory Medical Device Regulations Whitepaper The new medical device regulations (MDR) will come into force in May 2020.  In advance of the deadline, companies across the world are working to ensure that their devices will comply with the new regulations.  For many companies there is still much work to do. Also, companies are still actively seeking further information about the regulations and how they will be applied. We have produced our first medical device regulations whitepaper to look at the issues that will be faced by manufacturers and suppliers of medical devices. Read the whitepaper here. The 5 Responsibilities of the Person Responsible for Regulatory Compliance (PRRC) under MDR As part of our series of articles looking at some of the changes on the way for medical device regulation under MDR, we are looking at the role of the Person Responsible for Regulatory Compliance (PRRC). The role of QP is a familiar one for those working in the Pharma sector, but this is the first time in European medical devices legislation that a person is required to be appointed by a manufacturer to take specific responsibility for regulatory compliance of devices. Read the article here. 2nd Acorn Regulatory MDR Whitepaper: Be Prepared for May 2020 Our second Acorn Regulatory MDR whitepaper looks at the issues of unique device identifiers, the role of Eudamed under MDR, and post market surveillance.   Read the whitepaper here.