23 September, 2016 Linda Chatwin Esq, RACUL LLC, Senior Customer Solutions Consultant
|The Medical Device Directive (MDD)
is being recast as the Medical
Device Regulation. It's time to
learn some new rules.
It’s coming – and at this point, nothing will stop it. The Medical Device Directive (MDD) is being recast to a regulation – the Medical Device Regulation (MDR). It has been over four years in the making and the EU countries have spent many hours (actually over four years) working to agree on its Consolidated Negotiated Text.
Since the MDR is now a regulation as opposed to a directive, the member states in the EU are bound to abide to it – giving it strength equivalent to the FDA’s CDRH regulations in the US. The EU is the world’s second-largest medical device economic area/region, and the regulation, felt to be long overdue, will regulate devices not only manufactured and marketed within the EU, but also devices that will be imported into the EU. The regulation includes rules for determining device classification, requirements for quality systems, obtaining pre-market authorization, and monitoring device performance in the field, including reporting of adverse events.
The Consolidated Negotiated Text document – over 300 pages in length – was published on June 27, 2016. The document is being reviewed now in EU legal teams for drafting and technical errors. Once all is approved in the text, it will be translated into all the EU member languages, for formal publication, expected to occur late 2016--- however, most likely in first half of 2017. There is a provision for a three-year transition period, giving the medical device industry and regulators needed time to comply with the new and comprehensive provisions of the regulation.
Structure of the MDR
The MDR is significantly changed from the MDD, as one can imagine with the substantial volume of the regulation. It is broken into 10 chapters, with the following titles:
Chapter I – Scope and definitions
The scope of this new Regulation covers rules concerning the placing on the market, making available on the market or putting into service of medical devices and accessories to medical devices for human use. It also applies to clinical investigations on medical devices conducted within the Union.
Also, there are provisions for groups of products without a current intended medical purpose, taking into account the state of the art, to fall within the medical device definition and therefore become subject to the requirements of the Regulation.
Chapter II – Making available and putting into service of devices, obligations of economic operators, reprocessing, CE marking, free movement
Meeting the general safety and performance requirements as per the device intended purpose and as per demonstration of conformity including a clinical evaluation is required. The regulation includes provisions for the specific general obligations for economic operators such as the manufacturer, the authorized representative, the importer, the distributor, and person for regulatory compliance.
Chapter III – Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European databank on medical devices
This includes identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, and European databank on medical devices. Economic operators must be responsible in achieving appropriate level of traceability of devices in the period of at least ten (10) years after the last device covered by the declaration of conformity has been placed on the market.
One of the significant provisions specified in this chapter is the establishment of a Unique Device Identification (UDI) system. This also includes the establishment of a UDI database.
Chapter IV – Notified Bodies
In order to comply with a required conformity assessment procedure, the manufacturer must appoint a Notified Body that complies with the provisions stipulated in the new Regulation. The concerned Member State is responsible for designating a conformity assessment body as a Notified Body that will carry out conformity assessment activities that are in accordance with this Regulation.
Chapter V – Classification and conformity assessment
The provisions for classification of medical devices in the new Regulation are similar to the old MDD except for the participation of the MDCG (Medical Device Coordination Group). Devices are still divided into class I, IIa, IIb and III. However, in this new Regulation, the purpose intended by the manufacturer is also taken into account when classifying medical devices.
Chapter VI – Clinical evaluation and clinical investigations
The manufacturer must specify and justify the level of clinical evidence necessary to demonstrate compliance with the relevant essential requirements on safety and performance which shall be appropriate to the characteristics of the device and its intended purpose. Therefore, the manufacturer must plan, conduct and document a clinical evaluation in accordance to this new Regulation. The clinical evaluation and its documentation must be updated throughout the life cycle of the device concerned with the clinical data obtained from the implementation of the manufacturer’s PMCF and the post-market surveillance plan.
Chapter VII – Post-market surveillance, vigilance and market surveillance
The regulation contains requirements for establishing post-market surveillance system that must consist of the plan, report, and periodic safety update report. Under the Vigilance section of this chapter, the provisions for reporting of serious incidents and field safety corrective actions, trend reporting, analysis of serious incidents and field safety corrective actions, analysis of vigilance data, electronic system on vigilance and on post-market surveillance, and other implementing acts are specified.
Chapter VIII – Cooperation between Member States, Medical Device Coordination Group, Expert laboratories, Expert panels and device registers
Under this chapter, provisions for cooperation between Member States, Medical Device Coordination Group, expert laboratories, expert panels and device registers are specified.
Chapter IX – Confidentiality, data protection, funding, penalties
Chapter X – Final provisions – covers Commission activities, etc.
The 16 annexes to the Regulation covers such items as the essential requirements, technical documentation requirements, notified body requirements, classification criteria, UDI data elements, various conformity issues and clinical evaluations and investigations.
- Unique Device Identifiers (UDI) will be introduced gradually, similar to the system in place for the US market, to increase traceability of devices through the supply chain
- Importers and distributors will need to verify compliance of the device
- Notified bodies have the duty to perform unannounced audits and to conduct tests on medical devices to ensure compliance
- Pre-market approvals will be more strenuous, with more essential requirements so that technical files will need to be updated
- Some products that are not currently considered medical devices will now fall under the definition of medical device, as well as their accessories
- Software and mobile health apps designed for the purposes included in the definition of medical devices will be regulated
- New classification rules are presented
- Preparing for the new MDR
Since grandfathering from currently CE marked devices is not available, a conformity assessment for all devices will be required. Therefore, even though there will be a three-year transition period, it is wise to prepare a gap assessment between the MDD and the MDR, ensure that business agreements and processes are appropriate to the roles and responsibilities that will be imposed, and update technical files to ensure all requirements are met.
As a final note, companies would be well advised to keep track of new and revised guidance issued by the European Commission, and regulatory acts that may further implement the MDR.
Is your company ready for these changes? Will you be conducting a gap assessment to see where deficiencies lie? Please leave your comments below.
Ms. Chatwin has been involved with regulated medical products for over 30 years. She understands the global regulatory maze required to bring products to market, through years of watching regulations evolve and change. She holds a Regulatory Affairs Certification and is an attorney in the U.S. She has obtained product approvals for a wide range of products, and remains involved in changing requirements for medical devices worldwide. She has navigated many FDA inspections, and has negotiated favorable outcomes with FDA. Currently, she assists clients with regulatory issues and challenges, including implementation of UDI processes, performing mock audits, in-depth training on regulatory requirements and consulting on quality system development and improvement.