What were the drivers in the European Union (EU) for changing from the Medical Device, Active Implantable and In-Vitro Diagnostic Directives (MDD, AIMDD, and IVDD) to the Medical Device and In-Vitro-Diagnostic Regulations (MDR and IVDR)?
In my previous article for In Compliance Magazine (see In Compliance Magazine, June 2018), I brought up some of the current and upcoming challenges for the medical device industry in regard to the regulatory and quality systems space. One of the significant issues is the EU MDR. If you haven’t done a GAP assessment of your portfolio of devices and started preparations to transition your portfolio to the new Regulation you may not have enough time to be compliant with the MDR and could lose market access. You have less than a year to be ready for the MDR. The transition period started in May 2017, the MDR has a three year transition period ending 25 May 2020. If your MDD product certificate expires after 26 May 2020 you may have a partial reprieve, of up to 4 years, if you do not intend to change the product significantly. But you will still need to meet parts of the MDR even under this exemption.
The transition for your products to meet the MDR is a massive project and will require a lot of internal and external resources. This is not a project where just regulatory affairs experts can do all the work. You will need to work with engineering, your technical writers, manufacturing, operations, legal, regulatory, quality, clinical specialists, IT, your distributors, importers, authorized representative (AR), and your Notified Body (NB), etc. Many of these groups will need to work together. Upper management needs to be aware of the significant impacts on your organization and they should provide the approval for the resources (financial, personnel, etc.) needed to make this happen.
Several years ago there were about 80 Notified Bodies under the MDD. In 2018 there were about 50 MDD NBs left and the trends seem to be on the decline as NBs are having a hard time hiring the proper personnel to deal with the increased workload demands of preparing for the MDR while still maintaining the MDD workload, dealing with MDSAP, the transition that just finished for ISO 13485:2016, etc. Also, the designation process to become a NB under the MDR is a long process (taking a year or more) and not all NBs under the MDD have applied for the designation process for the MDR.
The impact on NBs, Economic Operators (manufacturer, an AR, importer, distributor, assemblers of systems and procedure packs), among other players, is massive. Here is a partial list of the significant changes/impacts on manufacturers, the NBs and others impacted by this new Regulation:
Brexit makes the BSI designation in the UK very unpredictable. The original Brexit date of 29 March 2019 was pushed off until 31 October 2019 by which time the UK and EU needs to agree on approval of a withdrawal agreement or a hard Brexit would happen. If there is an agreement the UK would exit the EU on 1 October 2019. (Note, this article was finalized in late-May 2019.) It is not clear what will happen as this is a political nightmare in the UK and impacts the rest of the EU 27 and many other nations around the world, since any manufacturer that sells product to the UK is impacted and also there are shortages of products hitting the UK from the unknowns.
Every company will have unique challenges and some common ones for this transition. This is a generic, “high-level” list which will help you prepare and hopefully fully implement, but there still could be a lot of additional details your company will need to deal with.
2. Do a cost-benefit analysis to determine if your legacy and new products will all go through this transition or decide to stop EU sales of some/all products. Consider the costs, time and resources needed for:
c. Project management team needs management support and executive level decision maker on team (recommended).
f. Report progress of MDR implementation to the master plan as a major input into your management reviews. Consider increasing how often the management review team meets to review the MDR implementation process.
5. Update MDR ‘living documents’ that require updating on varying basis depending on the document/process/requirement of the MDR. Such as:
6. Keep up to date on the ever-changing European regulatory environment as changes and notifications are released including, but not limited to:
There are a lot of web resources that may be helpful for keeping up to date on this massive endeavor. Here are some of the web resources I rely on a lot for keeping up to date on the MDR and its implementation:
Leonard (Leo) Eisner is a senior contributor to InCompliance Magazine, and principal medical device product safety and regulatory consultant at Eisner Safety Consultants, which specializes in helping medical device manufacturers through product safety, international regulatory and quality system processes. Eisner’s focus is on active medical electrical equipment. Eisner is currently on several IEC TC 62 / SC 62A committees MT28 (Electrical Hazards), MT 30 (Overheating, fire protection and additional hazards), Ad Hoc Group 62368 (Sub-group of MT28 on feasibility of incorporating IEC 62368-1 into 60601-1) and WG14 (In charge of IEC 60601-1 Interpretations) that are working on the draft IEC 60601-1, 3rd edition + Amendment 2 project, is the US co-chair of IEC SC62D (majority of IEC 60601-2-xx and IEC/ISO 80601-2-xx standards), convener of IEC SC62D JWG9 (IEC/ISO80601-2-58) and a committee member of IEC TC 62 / SC 62A , JWG6 (home care applications), JWG8 (EMS environment), and on the US TAG for TC62, SC62A, SC62D, AAMI Home Care & EMS environments (HA) AAMI Electrical Safety (ES – develops ANSI/AAMI ES 60601-1) and AAMI Hospital Bed Working Group (EV/WG 05). He is a registered professional engineer in safety and has over 30 years-experience in product safety. Eisner is a member of RAPS, AAMI, ASQ, and the IEEE and the manager of the LinkedIn discussion group IEC 60601 Series – Medical Electrical Equipment. He can be reached at Leo@EisnerSafety.com.
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