Once again I’ve asked Karen Fleshman, co-founder and COO of Haskins Advisory Group, to step in and cover the recent EU MDR and IVDR Conference that focused on Unique Device Identification (UDI). I’ll return after the holidays with more coverage of pharma serialization. Thanks Karen! –Dirk.
On December 4 – 6, 2017, the European Medical Device (MDR) and In Vitro Diagnostic Medical Device (IVDR) Regulations Conference was held in Orlando, FL. The conference was designed to educate, support, and assist US based medical device manufacturers in gaining critical insight on the requirements of the European Union (EU)’s Unique Device Identification (UDI) compliance program. Though the conference was focused on the EU it was abundantly clear that other countries, such Turkey, Japan, UK, and several others program are on the horizon, each with their own unique country specific requirements.
What is a Manufacturer to Do?
With all these varying compliance programs on the horizon, what is a manufacturer to do? I would highly recommend creating a UDI team under the direction of the Regulatory Affairs department. The first step in the now worldwide compliance landscape is to identify where you do business. Specifically, the countries where you sell your medical devices. After the country identification process, then it’s important to determine implementation timelines based on your device classes and let your company’s business goals drive your priorities, for example: if the EU is your second largest market… the EU’s implementation process and timeline should be the focus and priority.
The FDA’s UDI compliance program gave manufacturers a precursor of the expectations of the medical device regulatory community. It did a great job of establishing the foundation to help manufacturers understand the requirements for compliance. The EU has built extensively on the US implementation program. As a matter of fact, there are many reminders of the US program when you compare two.
One of the highlights of the conference was identifying the differences and similarities of the two programs. Who best to articulate this topic, than Jay Crowley, former FDA Senior Advisor for Patient Safety. Crowley is now Practice Lead for USDM Life Sciences. USDM Life Sciences provide strategy guidance and implementation services to help medical device companies meet the requirements for the FDA UDI Final Rule and achieve the benefits of improved product identification throughout the Supply Chain.
Differences Between US and EU
The goals of the two programs are very similar with the exception of improved purchasing, waste disposal policies and stock management by health institutions. An unintended potential benefits of the US FDA’s program is that Healthcare providers have found the data in the Global Unique Identification Database (GUDID) potentially useful and would be willing to incorporate the UDI into their IT systems – item masters, HER, claims and other device registries, if the data is complete and accurate. Another difference is that medical devices and in vitro diagnostic devices regulations are called out separately with medical devices classified by numbers and in vitro diagnostic devices classified by letters.
On December 5th, Crowley presented a presentation entitled: the US and EU MDR/IVDR UDI Requirements – Similarities, Differences and Implementation Issues.
Below is an outline of the content of the differences:
- Responsibility: US Labeler vs EU Manufacturer – labeling responsibilities are expanded to include additional roles in the Supply Chain, for example contract manufacturers, medical device sterilizers, distributors, etc.
- Single Use Devices (SUD) packaging exception: EU limited to Class 1/11a [Class A/B] – also, less restrictions (SUD and individual labeled and packaged)
- Procedure pack (convenience kits) and Systems: EU individual devices must also be UDI compliant – unless SUD or already exempted
- Configurable device: EU UDI on separately distributed components
- IVR Kits: EU UDI Also for individually distributed reagents and article
- Standardized data format (YYYY_MM_DD) not required
- Software: EU label and software UDI must be identical
- Class I devices: EU needs both DI and PI
- DM UDI: EU UDI must be both AIDC and HRI
- Direct Mark: EU does Not exempt devices that are only cleaned between different patient use and single patient use
- Existing inventory exemption: EU does not have
To find more information on these differences, check out http://www.mdrivdr.com/mdr-ivdr-compliance/.
EU – New Regulations Adoption
The timeline is critically important and it comes directly from the European Commission Medical Devices website: https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en#new_regulations
On April 5, 2017, two new Regulations on medical devices were adopted.
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
- Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
- MDR– 3 years after entry into force for the Regulation on medical devices – Spring 2020
- IVDR– 5 years after entry into force for the Regulation on in vitro diagnostic medical devices – Spring 2022
The New Regulations in a Nutshell:
The new Regulations contain a series of extremely important improvements to modernise the current system. Among them are:
- stricter ex-ante control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level
- the reinforcement of the criteria for designation and processes for oversight of Notified Bodies
- the inclusion of certain aesthetic devices which present the same characteristics and risk profile as analogous medical devices under the scope of these Regulations
- the introduction of a new risk classification system for in vitro diagnostic medical devices in line with international guidance
- improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification
- the introduction of an “implant card” containing information about implanted medical devices for a patient
- the reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorisation of multi-centre clinical investigations
- the strengthening of post-market surveillance requirements for manufacturers
- improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance (2)