Transitioning to the European Medical Device Regulation: an Overview
As the year comes to an end, I thought it would be fitting to give a breakdown of the European Medical Device Regulation (MDR) and what transitioning implies.
Before we go any further, let's clarify a few things. Medical devices that are sold in the European Union have to bear the CE mark. This places an obligation on medical device manufacturers to conform to the relevant legislation. Once conformity is met, the manufacturer is given a CE certificate by a notified body and can use the sought-after CE symbol.
Traditionally, the applicable legislation that defined the requirements for achieving the CE mark was 1. the Medical Device Directive (MDD, formally known as Council Directive 93/42/EEC) and/or 2. the Active Implantable Medical Devices Directive (AIMDD, formally known as Council Directive 90/385/EEC). In other words, manufacturers had to conform to these directives, as well as to the applicable national legislation of the specific country (or countries) they were trying to sell in. Simply put, if you were selling in Germany, you would have to conform to the MDD and/or AIMDD, and any additional German legislation. This regulatory system has been in place for over 25 years and while most will argue that this system was fit for its purpose, the need to have more harmonization and stricter requirements throughout the EU led to the creation of the MDR.
Formally known as Regulation (EU) 2017/745, the MDR entered into force in May 2017 through an agreement between the European Council, the European Commission, and the European Parliament. Conceptually, the idea was simple: repeal the MDD and AIMDD, replace them with the MDR, and give manufacturers and notified bodies enough time to transition from one system to the other.
Quick fact: a notified body (NB) is an organisation that has been designated by an EU member state (the designating authority) to assess whether manufacturers and their medical devices meet the requirements set out in legislation
However, the timeline of events shown here makes it clear that this transition is more complicated than expected.
7 Key differences between MDR and MDD
Here is a list of 7 key differences (there are far more than just 7 but by way of brevity I've made the list as short as possible while still being relevant) between the MDR and the MDD:
MDR is the law, applied at the Union level, while MDD is a directive applied in combination with applicable national legislation;
MDR has more comprehensive requirements: 123 articles and 17 annexes compared to MDD's 23 Articles and 12 annexes;
MDR places more scrutiny on device safety and performance: the MDR's GSPR (general safety and performance requirements) consists of 23 sections and replaces the MDD's essential requirements which comprise of only 14 sections;
MDR requires manufacturers to put in place a UDI (unique device identification) system. This ensures better traceability of devices and device families in the market;
MDR places more emphasis on clinical data and post-market surveillance;
MDR requires manufacturers and economic operators to register their device information, as well as additional information, on an electronic database (EUDAMED);
MDR defines new device classification rules that may result in devices being in a higher class than under the MDD.
NBs that can issue MDR certificates
As I mentioned previously, NBs also need to conform to the requirements of the MDR if they want to carry on issuing new EC certificates. According to the NANDO database, there are currently 54 NBs that can issue EC certificates under the MDD, with 12 of them also issuing EC certificates under the AIMDD. Unfortunately, the numbers are not as promising under the MDR. There are currently only 18 NBs that can certify products under the MDR.
Although there are only 18 NBs under the MDR as of today, there may be more in the next 6 months.
With just over 6 months until the date of application of MDR, two-thirds of the NBs that can certify under the MDD have not yet received MDR approval, and time running out. What does this mean for you, though, if your NB is part of the daunting 66%? While you may want to be reactive (or proactive, depending on how you see it) and immediately switch to a new MDR-ready NB, let's look at a few practical cases that could apply.
CASE 1: your EC certificate, issued under the MDD (or AIMDD), is expiring before the date of application of the MDR
If your certificate expires before 26 May 2021, you are eligible for an EC certificate renewal under the MDD (or AIMDD), provided that there are no major design changes to the device (see CASE 2). This certificate is valid for 5 years from the renewal date or for 4 years after the date of application of the MDR, whichever comes first. For example, your certificate was renewed in January 2019 and is therefore valid until January 2024 because this date comes before 26 May 2025 (4 years after 26 May 2021). Essentially, this recertification buys you time to prepare yourself for MDR certification. This allows you to evaluate whether you should keep or change your NB, and determine what organizational changes you may need.
CASE 2: your EC certificate, issued under the MDD (or AIMDD), is expiring before the date of application of the MDR, and you would like to make design changes
If the design changes are major, you will not be eligible for an EC certificate renewal under the MDD (or AIMDD). You will require certification under the MDR. In this case, you need to consider the tight timeline, the fact that your NB may not be MDR-ready, and the planning and costs associated with implementing the design change and certifying under the MDR. If the operational risk is too high, you could opt to re-certify under MDD (or AIMDD) and prepare yourself for MDR certification, as per the timeline.
CASE 3: you have recently renewed your EC certificate under the MDD (or AIMDD) and your device is in circulation/distribution in the EU market
You may continue to make your device available on the market until 26 May 2025 or until the EC certificate expires, whichever comes first. In this case, you should put in place a transition plan to prepare yourself for MDR certification when your EC certificate expires. Keep in mind that after 27 May 2025, no devices certified under the MDD (or AIMDD) can be made available on the market.
CASE 4: your EC certificate, issued under the MDD (or AIMDD), is expiring after the date of application of the MDR
If your EC certificate expires after 26 May 2021, you will have to get MDR certification when the certificate expires. For example, your certificate expires in December 2021. This means that up until this date, you can sell your device in the EU market. An alternative, if you still have time (and a generous NB), you can opt to recertify before 26 May 2021 so that your EC certificate remains under the MDD. If you've run out of time and need to recertify under MDR, the best place to start is to do a gap analysis to see the new/additional MDR requirements that you will have to meet.
So, what now?
With the clock ticking, and the transition seeming complex, you must put in place a plan of action that will ensure that you reach the market or maintain your device(s) on the market. Whether you have to transition to the MDR in one year or 4 years, you will have to implement the MDR into your organization. Here are 5 steps that I propose to get you started:
Classify your device according to the MDR classification rules;
Perform a gap analysis if you are transitioning a device from MDD to MDR: this will inform your plan of action and help define your strategy and the resources needed;
If you are placing a new device on the market, perform an article-by-article assessment to determine the plan of action;
Start compiling technical documentation according to the plan of action;
Internal conformity assessment and audit
Once again, by way of brevity, I have made the list as short and concise as possible. This should not take away the complexity and effort that come with doing these steps. Infomed Consulting has created a framework to help you transition to MDR. To find out how we may assist you, book an online consultation, or contact us.