A profound realization was made while performing a routine MDR gap analysis of Medical Device Academy’s technical documentation procedure.

In this article I wanted to discuss the functional effect that a gap analysis can have on your entire quality system. Everything mentioned below is because I performed a MDR gap analysis against a single procedure which resulted in the addition of three words to a single sentence. This small modification was made simply for clarification of a sentence that was already compliant without the change. Those three words made me reexamine the entire procedure. Then I tried to identify possible interpretations of that one sentence both before and after the modification. Finally, I questioned how adding three words might affect quality systems as a whole.

What was the section reviewed in the MDR gap analysis?

The MDD (i.e. 93/42/EEC) did not include a section that defined the requirements for technical documentation. The MDD does not include the phrase “device description,” or “intended patient population.” Therefore, when the MDR came into force, companies were forced to update their technical documentation procedure to comply with the new Annex. The section of the regulation that I was performing the MDR gap analysis against was Annex II. Specifically, subsections 1.1a) and 1.1c):

• 1.1(a) “product or trade name and a general description of the device including its intended purpose and intended users“;
• 1.1c) “the intended patient population and medical conditions to be diagnosed, treated and/or monitored and other considerations such as patient selection criteria, indications, contra-indications, warnings;“

(taken from the English Version of Regulation EU 2017/745 on 08/30/2018)

There are only two places in the MDD where the phrase “intended users” is found: Article 11(14) and Annex I(1). In Annex I(1) of the MDD, the Directive clarified that design of devices shall include: “consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other
users).” The introduction of the phrase “intended patient population” in the MDR forced me to reevaluate the wording we were using in our SYS-025 Technical Documentation Procedure. The wording we were using was: “users and patients.” Therefore, first I added the word “intended” before “users” and “patient”, and second I added the word “population” after “patient.”

Why would the MDR require these specific changes?

These are very small changes but the changes were meant to more clearly explain that documentation was needed for very specific areas. Previous versions of the procedure left more room for interpretation that intended users may not have been differentiated as strongly from intended patients, especially for cases where they are one in the same. These two subsections of Annex II, 1.1 (a) and 1.1 (c), outline that there are two specific populations of real people that must be taken into account within the device description and design specification areas of your technical documentation:

• the intended users, and
• the intended patient.

Even if the user and the patient represent the same person, these are two separate areas that require technical documentation. Intended users, whom may or may not be within the “intended patient population” that the device was designed for, should be entirely separate on your technical documentation.

Take for example, a home use lancet device included within a glucometer kit. The intended user is probably going to be the diabetic patient who wishes to check their blood glucose levels at home. In this case the intended user would also be a member of the intended patient population.

However, because this is not always the case there should be a clear separation of the documentation between the intended users of 1.1(a) and the intended patient population in 1.1(c). An example of this would be something like a surgical scalpel. A medical device that would probably be intended to be used by a physician within the controlled environment of a surgical procedure. In this example scenario the intended patient population would differ from the user because the patient would be the population of people who would need to undergo the above mentioned surgical procedures, but the user of the device is the physician or surgeon actually performing the procedure.

Considerations going beyond my MDR gap analysis

Everything that we are talking about is for intended patient populations or intended users. Documentation regarding these areas is important for several reasons and strong record keeping early on in the device development stages will help with things like statistical analysis, tracking and trending, and even possible modifications to Instructions For Use or labeling in the future. Most people performing a gap analysis would just make the changes and move forward without a second thought. However, the phrase “intended patient population” was introduced to the MDR for a reason, and it forced me to think beyond the task at hand.

Let us look back at our diabetic patient with the home use glucometer kit. I like fleshing my characters out, and providing a back story really helps me mentally associate these fictitious characters with the potential real-life patients they may represent.

I am going to name him Matthew D. Mellitus Jr. He is 28 years old. A morbidly obese type II diabetic, and a married father of two. Beyond the extraordinary play on words with Mr. D. Mellitus, II is I promise that there is a purpose behind this.

Matt is the intended user of the specific glucometer kit that he has. It contains within it, a glucometer, alcohol prep pads, a lancet device, spare lancets, and a container of test strips. He is also a member of the intended patient population because he is a diabetic with orders from his primary care physician to check his blood glucose levels at home.

One day while at home his spouse finds that it appears he is sleeping at an odd time of day and is rather unarousable. Knowing that he is diabetic she checks his blood sugar using that same glucometer kit. Now this is a broad made up but plausible scenario. Is his spouse an “intended user”? Sure, Matt the diabetic is still a member of the “intended patient population”, but ask yourself some of these follow up questions:

• Did the manufacturer of the glucometer kit design and document the intended user to include caretakers of the “intended patient population”?
• If not, does this mean that Matt’s spouse was using the glucometer in an off-label manner?
• If both caretakers and patients are intended users, are the Instructions For Use written in such a manner that they are clearly understood when applied to testing blood glucose levels on others as well as yourself?
• Perhaps this was an unforeseen human factor when designing the glucometer kit that needs further study?

I promise that questions like these are better asked and incorporated into the design and development of a medical device early on rather than having to address them post-market release and have to consider recalls, notifications, corrective actions, etc. in the future.

Do the questions end with my MDR gap analysis?

All of the above discussion resulted from a single sentence, being tweaked just a little bit, in order to make a procedure more clear and leaving less room for interpretation.These are just theoretical questions that should be asked. As the ‘rabbit hole’ always seems to go deeper and branch off so do some of these theoretical situations. This was just a bit of a back and forth conversation with myself regarding a very specific section of Annex II. As we delve deeper into the proverbial rabbit hole, consider again the situation where Matt’s spouse used the device. If she was not an “intended user,” does this qualify as “misuse of the device”? Maybe, or maybe not, but each situation will result in different answers to these questions.

If you go back to Annex I, Chapter 1, Section 3(c) it states, “estimate and evaluate the risks associated with, and occurring during, the intended use and during reasonably foreseeable misuse.” If that is considered misuse, is it ‘reasonably foreseeable’ (taken from the English Version of Regulation EU 2017/745 on 08/31/2018)? What is considered misuse? The EU MDR does not have misuse in its definitions. In fact, the term misuse is only even used three times. To narrow down whether or not this is reasonably foreseeable misuse we need to find a working definition within an accepted harmonized standard or other regulation that applies to the governance of medical devices within the same manner that the EU MDR does.

That same thoroughness needs to be applied to how misuse may be considered foreseeable. Maybe through human factors studies? Maybe through post market surveillance it is discovered that the device is sometimes used by someone other than an intended user, or for something other than the intended purpose. Should misuse be discovered, or suspected does it fall under the realm of it being ‘reasonably foreseeable?’ Ask these questions early, ask them often and then don’t be afraid to ask if they still apply in the future. Have regulations or standards changed? Proactive measures can help discover issues sooner. This lets risks be addressed sooner and ultimately could prevent negative outcomes and experiences from the patients these devices are meant to help.

Conclusions of this MDR gap analysis

I had these thoughts while updating Medical Device Academy’s procedures. First, procedures should always be living documents that can grow and change as standards and regulations metamorphasize to meet the needs of the ever evolving medical device community. This MDR gap analysis applies largely to technical documentation and as such we updated our technical documentation procedure. Every time we analyze quality system documents and technical documentation through the lens of a new standard or regulation, we are certain to expand our appreciation for the complexity of medical device design and development.

Did you forget any of the MDR labeling procedure requirements when you were updating your device labeling for CE Marking?

MDR Labeling Procedure

Don’t forget to subscribe to our YouTube channel for more medical device quality and regulatory training. The topic of this article is how to create an MDR labeling procedure for compliance with Regulation (EU) 2017/745 (MDR) for CE Marking of medical devices. The MDR does not actually include a requirement for a labeling procedure. In fact, the MDR doesn’t even specifically require that you have ISO 13485:2016 certification. ISO 13485:2016, clause 7.5.1 states that you shall implement “defined operations for labeling and packaging,” but the standard doesn’t specifically say that “the organization shall document procedures” for labeling. In 21 CFR 820.120, the FDA states that “each manufacturer shall establish and maintain procedures to control labeling activities.” But there is no similar requirement in the MDR.

MDR Quality System Requirements

Article 10 is the section of the MDR that defines the obligations for device manufacturers to create quality system procedures, but a labeling procedure is not specifically mentioned. Article 10(9)(a) states that your quality system shall include “a strategy for regulatory compliance, including…procedures for management of modifications to the devices covered by the system,” and this would include label changes and other control of other design changes. The next paragraph states that your quality system shall include, “identification of applicable general safety and performance requirements.” The general safety and performance requirements (GSPRs) are found in Annex I of the MDR, and the very last GSPR (i.e. GSPR 23) is for your label and instructions for use.

Then, which changes do you need to make for the MDR labeling procedure?

The GSPRs in Annex I of the MDR are longer than the Essential Requirements that were in the MDD. In addition to the new requirements for UDI compliance (which you should address in a UDI Requirements Procedure), GSPR 23 has new general requirements (i.e. 23.1) and new requirements for information on the sterile packaging (i.e. 23.3). There is also a more detailed specification for the information on the label (i.e. 23.2) and the information in the instructions for use (i.e. 23.4). The approach for demonstrating compliance with the GSPRs suggested in the MDR is to provide a checklist. Therefore, most manufacturers of CE Marked devices have replaced their Essential Requirements Checklist (ERC) with a GSPR checklist. However, if you are reviewing a draft label for approval, you don’t want to review and update your entire 22-page, GSPR checklist for every label.

The more efficient approach is to create one or more labeling checklists that are specific to the requirements in GSPR 23. If you create a separate checklist for the label, the information on the sterile packaging, and for the information in the instructions for use, then you would have three shorter checklists to complete. The label checklist and the checklist of the information on the sterile packaging would be only one page each, while the checklist for the instructions for use would be approximately four pages. There may be additional labeling requirements for specific countries and types of devices. Electrical medical equipment also has specific labeling requirements in IEC 60601-1 and IEC 60601-1-2. You will also need to create a user needs specification that can be used as criteria for summative usability testing (i.e. validation that the design and risk controls implemented meet the user needs specification). You should also document a use-related risk analysis (URRA), and perform formative testing, in order to identify critical tasks which need to be in the instructions for use to prevent use errors.

Are there any other MDR requirements that you should address in a labeling procedure?

There are two other requirements that should be addressed in your labeling procedure. The first is the general labeling requirements in GSPR 23.1. Withing GSPR 23.1, there are actually nine “sub-requirements.” The first “sub-requirement” in GSPR 23.1 is to provide the identity of the device, your company, and any safety and performance information needed by the user on the packaging or the instructions for use, and on your website. Many manufacturers do not want to make this information available on their website, because it makes it easier for competitors to copy the instructions for use, but this is not optional. This requirement and the other eight requirements in GSPR 23.1 could be included in your procedure or as part of a fourth labeling checklist associated with your MDR labeling procedure.

The second requirement is the requirement to translate your instructions for use into an official Union language(s) determined by the member state where your device will be made available to the intended user or patient. Creating these translations, and verifying the accuracy of the translations, can be expensive and burdensome–especially if your device is sold in most of the member states.

You might also consider implant cards as labeling requirements and try to add them to your MDR labeling procedure. However, if the requirement for implant cards (see Article 18 of the MDR) is applicable to your company you should create an implant card procedure instead because this is a detailed and critical requirement that will not apply to most of the other labels in your company. You should make sure that the implant card procedure is compliant with MDCG 2021-11 released in May 2021 and MDCG 20201-8 v2 release in March 2020. These guidance documents also have great examples of how to design your implant cards.

Other changes in labeling requirements

The ISO 15223-1:2016 standard has been revised and was expected for release at the end of 2020. However, only draft versions are currently available (i.e. ISO/DIS 15223-1:2020). This new version of the standard for symbols to be used with labeling will also need to be updated shortly in your MDR labeling procedure. This new version is already referenced in the medical device standard for information provided by the manufacturer (i.e. EN ISO 20417:2021)–which supersedes EN 1041:2008. Consultants and chat rooms have argued over whether the requirement for identifying the importer must be on the label or if it could be presented in other documents. EN ISO 20417:2021 resolves this dispute in section 7.1: “Where necessary, the label of a medical device or accessory shall include the name or trade name and full address of the importer to which the responsible organization can refer.” In the note following that clause, it clarifies that “This can be required by the authority having jurisdiction.” There is even a new symbol referenced for importers (i.e. Symbol 5.1.8 in ISO 15223-1).

If you have specific questions about device labeling or MDR compliance, please use our calendly app to schedule a call with a member of our team. You can also purchase our labeling and translation procedure (SYS-030) to save yourself the time and effort of making your own versions of the labeling checklist described above.

About the Author

Robert Packard is a regulatory consultant with 25+ years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.

This article breaks down and reviews the new implant card requirement as well as Article 18 of EU 2017/745.

We also have available for sale, SYS-037 Implant Card Procedure written to be Article 18 compliant of Regulation (EU) 2017/745, and includes;

• SYS-037 A, Implant Card Procedure
• FRM-044 Checklist for Information to be supplied to the patient with an implant
• FRM-045 Implant Card Checklist for Article 18 Reg 2017-745
• Native Slide Deck for Implant Card Webinar
• Recording of the Implant Card Webinar

Implant Card Requirement, a new requirement from Regulation (EU) 2017/745.

One of the new changes to the regulation is an introduction of a new requirement for implantable devices. These devices must now come with an “implant card” that contains information about the implanted medical device for the patient. The responsibility of the implementation of the new implant card rules lies with the manufacturer of the implantable device and the health institution as required by the EU member states.

What is an implantable device?

Before discussing the specifics of the implant card, we must first define what an implantable device is to determine if the implant card requirements apply to your device or devices. Article 2 Definitions, number 5 of Regulation (EU) 2017/745 defines and outlines what is considered an implantable device.

“(5) ‘implantable device’ means any device, including those that are partially or wholly absorbed, which is intended:

– to be introduced in the human body, or

– to replace an epithelial surface or the surface of the eye,

By clinical intervention and which is intended to remain in place after the procedure.

Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device; “

(Taken from http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745 English version)

Is my device considered implantable?

Working with the above definition of an implantable device, you can now compare those requirements against your own devices to determine if they are considered to be an implantable device or not. This can be done by performing a gap analysis of the definition against your device.

Consider what your device is and ask yourself the following questions:

Is my device intended to be partially or wholly absorbed?

If the answer is no, then your device may not be an implantable one. If it is, then you must keep asking yourself questions until you can sufficiently determine your device’s status as implantable or not.

Is my device intended to be introduced in the human body?

No. Ok, that is fine, but is it intended to replace an epithelial surface or the surface of the eye?

To make an awful analogy of the process, it is almost like playing a game of Guess Who with your device. Instead of asking your device if they have red hair or a mustache, you have to ask your device questions like, “Are you intended to remain in place after the procedure?”.

The gap analysis is fine, but you also have to consider some other factors within the wording of the definition. Be careful navigating the specifics because the devil is in the details. In the definition, which is only eighty-nine words long, by the way, uses the word “intended” three different times.

That is important because the definition applies not only to some of the characteristics and uses of the device but also to the intent behind the device. Just because the device can be wholly introduced into the body does not mean that the device is ‘intended’ to be. A better example would be, by clinical intervention, can your device remain in place after the procedure? Could it, perhaps, but is it intended to be? Also, is it the intent of the device to be done so by clinical intervention?

Where to find the implant card requirement?

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices is where the introduction of implant cards can be found. The definition of an implantable device is found in Article 2 Definitions, definition number 5.

Article 18- ‘Implant card and information to be supplied to the patient with an implanted device’ is where the implant card requirements can be found. This article contains three sections and four subsections pertaining to implant cards.

Article 18 Implant card requirement and information to be supplied to the patient with an implanted device

Below is article 18 in its entirety so that we can discuss it further in detail.

“1. The manufacturer of an implantable device shall provide together with the device the following:

The information referred to in the first subparagraph shall be provided, to make it available to the particular patient who has been implanted with the device, by any means that allow rapid access to that information and shall be stated in the language(s) determined by the concerned Member State. The information shall be written in a way that is readily understood by a layperson and shall be updated where appropriate. Updates of the information shall be made available to the patient via the website mentioned in point (a) of the first subparagraph.

Also, the manufacturer shall provide the information referred to in point (a) of the first subparagraph on an implant card delivered with the device.

2. The Member States shall require health institutions to make the information referred to in paragraph 1 available, by any means that allow rapid access to that information, to any patients who have been implanted with the device, together with the implant card, which shall bear their identity.
3. The following implants shall be exempted from the obligations laid down in this Article: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors. The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend this list by adding other types of implants to it or by removing implants therefrom.”

(taken from http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745)

Who does the implant card requirement apply to?

Section 1. of Article 18 states explicitly that it is the manufacturer who shall supply the information. Fortunately, it is also outlined what information needs to be included and some guidance on how to provide the information.

Take note, though, that the article states it “shall” be provided, “together with the device.” This means that merely having the information available or accessible such as a downloaded PDF on your website, is not sufficient to comply with section 1. Because that is not being supplied together with the device as outlined.

Section 2. of Article 18 applies to member states’ requirements of health care institutions.

Section 1 of Article 18

Section 1 is by far the most extended section of the article and outlines precisely what information must be provided with the implantable device. Not only is this information that must be provided, it specifically must be provided by the manufacturer. The subsections are broken down by topic and can be summarized as the information, warning, maintenance, and misc. Sections.

Section 1. Sub-Section A

This sub-section outlines the specific identifying information that must be provided. It is even specifically “information allowing the identification of the device.” For devices that are produced and manufactured compliant with other standards such as ISO 13485 or the QSR portion of the United States Code of Federal Regulations, a lot of this information is the same information that is required for traceability.

Besides the generic “information allowing the identification of the device,” the other specific information that ‘shall’ be provided is:

• The name of the device,
• The device serial number,
• The lot number of the device,
• The UDI,
• The model of the device,
• The name of the manufacturer,
• The manufacturers address,
• The manufacturers’ website.

They don’t just want your device’s driver’s license; they want the driver’s license, library card, passport, blood type, and favorite color. This is done for a purpose but also carries some implications on the maintenance actions of the manufacturer.

First such strict ID requirements mean that the device is traceable and identifiable. There should be absolutely no doubt about who made the device. In the event of an incident, that device should be traceable back to when and where the individual components were created and assembled into the final device. For traceability of an incident, tracking for corrective or preventive action, or just general inventory tracking this is the type of strict diligence that is expected when the end-user or patient is receiving medical care with an implantable device. There is no demonizing of this requirement. Yes, it is strict, but it is also just part of good housekeeping for a manufacturer in general. Only now it must be provided to the patient receiving care with the device as well.

What is implied is that the information provided along with the device is somewhat of a living document, and the information could vary a bit from patient to patient. Because things like lot numbers or any number of trackable metrics used with the UDI are included, the implant card information cannot be generically the same for each device but that it will have sections that are specific to individual devices. Sure this may initially create some logistical headaches for keeping track that the implant cards don’t get mixed up in situations where the devices are being manufactured, but this creates a level of accountability that is designed for the ultimate safety of the end patient.

Section 1. Sub-section B

Sub-section B contains the warning information of the device. The first part is pretty self-explanatory as meaning literally what is stated “any warnings” and “precautions”. It is the next part that I do not interpret literally. Where it says “measures to be taken by the patient or a healthcare professional with regard to reciprocal interference with reasonably foreseeable external influences, medical examinations or environmental conditions”.

If I were the manufacture of an implantable medical device, I would most definitely include measures to be taken by the patient as well as measures to be taken by a healthcare professional. There are a couple of spots that use the word ‘or’, and if it were me, I would read it ‘as well as’.

I say that for a few reasons. One is that without explicit clarification of a governing body as exactly what a silly little word like that is intended to me, this creates an area that is open for debate. Does that ‘or’ mean that at least one of those needs to be included and the rest can be excluded?

As one who likes to err on the side of caution, if you have the information available, why would you not provide it? By going above and beyond not only demonstrates your goodwill but also avoids hang-ups where an auditor might not agree with how you viewed the requirement, and you end up with a nonconformity, or in the same situation with an incident investigator. Ink is cheap; liabilities are expensive.

Section 1. Sub-section C, and Sub-section D.

These two subsections are relatively short and straight forward.

“(c)         any information about the expected lifetime of the device and any necessary follow-up;

How long can the user expect your device to last once it has been implanted?  I there any maintenance they should be performed? Perhaps once a year, a physician needs to double-check the device placement?

(d)         any other information to ensure the safe use of the device by the patient, including the information in point (u) of Section 23.4 of Annex I.”

The rest of Section 1. Of Article 18.

“The information referred to in the first subparagraph shall be provided, to make it available to the particular patient who has been implanted with the device, by any means that allow rapid access to that information and shall be stated in the language(s) determined by the concerned Member State. The information shall be written in a way that is readily understood by a layperson and shall be updated where appropriate. Updates of the information shall be made available to the patient via the website mentioned in point (a) of the first subparagraph.

Also, the manufacturer shall provide the information referred to in point (a) of the first subparagraph on an implant card delivered with the device.”

(Taken from http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745 English version)

At the end of this section, it provides a little bit more information about the purpose of the article but also lays out some guidelines for how to make the required information available.

I specifically mentioned earlier that having the information slapped on a website is not enough by itself. The text states, “any means that allow rapid access to that information”. Certainly, available on the internet is a means that allows rapid access, and it is if you have internet. Using a web-based approach like that is assuming that all the possible patients all have the technology and budget to reach the information. This means that every single possible patient needs a means to access the internet, and the money to pay for internet access. Also, being able to simply access the information rapidly isn’t necessarily providing the information “together with the device” as required.

You also need to have a conversation with your notified body and determine what languages are required by the member state in which your device is sold. It does not do the patient much good if they do not understand the language in which the information is being presented. It also needs to be presented in easy to understand terms, not in technical jargon.

Updates, unlike the initial presentation of information, needs to be included on your website. Specifically, the website that was included in the implant card given to the patient.

Section 2. of Article 18

Unlike what we saw in Section 1. Section 2. Outlines requirements for the health institutions and not the manufacturer. More specifically, Section 2. Requires member states to require health institutions to perform actions.

This section makes health institutions provide the same information that manufacturers had to provide to patients who have been implanted with a device, with the same stipulations as to how the information is provided. However, it also includes the health institution to include their identity on the implant card as well.

2. Member States shall require health institutions to make the information referred to in paragraph 1 available, by any means that allow rapid access to that information, to any patients who have been implanted with the device, together with the implant card, which shall bear their identity.
   

(Taken from http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745 English version)

Exemptions allowed in Article 18.

Section 3 of Article 18 is the list of exempted implants, exempted devices are:

• Sutures
• Staples
• Dental Fillings
• Dental Braces
• Tooth Crowns
• Screws
• Wedges
• Plates
• Wires
• Pins
• Clips

This is not an exhaustive list and can change with time at the discretion of the Commission. What it has done is taken implanted devices and exempted some of the most common and widely used ones. Thankfully so too, imagine if every staple needed an implant card to be presented to the receiving patient with individual batch and identifying numbers. Then coordinate the effort with a health institution so that the card also bears their identification as well. This would quickly become exhaustive.

3. The following implants shall be exempted from the obligations laid down in this Article: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors. The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend this list by adding other types of implants to it or by removing implants therefrom.”
   

(Taken from http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745 English version)

This article outlines an EU MDR quality plan for compliance with European Regulation 2017/745 for medical devices by the May 26, 2020 transition deadline.

Biggest MDR quality plan mistakes

Implementing an MDR quality plan is not just about updating your technical file and the procedures specific to CE Marking of medical devices. You need to make sure that you have planned to provide adequate resources for the successful implementation of your plan. Resources fall into four major categories, and all four should be addressed in a formal MDR quality plan that you have reviewed and approved during a management review meeting (i.e., ISO 13485:2016, Clause 5.6.3d). First, you need to provide adequate training. Second, you need to provide adequate equipment–such as UDI printing software and an electronic quality system database. Third, you need to provide adequate personnel. Fourth, you need to revise and update your quality system procedures.

European companies concentrated enormous resources in 2018 to prepare for the implementation of the EU Regulations in 2020. This may seem early, but most of those companies are realizing they should have started in 2017–immediately after Regulation 2017/745 was approved by the European Parliament and Council. In contrast, most companies in the USA were focusing on ISO 13485:2016 certification and MDSAP certification. Unfortunately, many CEOs were told that there is a “soft-transition,” and they have until 2024 to implement the new regulations. While it is true that most CE Certificates issued by notified bodies will be valid until their expiration date, and that date could be as late as May 25, 2024, it is not true that companies have until 2024 implement the new regulations. Quality system requirements in Article 10 of the MDR, and compliance with the MDR for economic operators, must be implemented by May 26, 2020. Any medical devices that are being reclassified will require full implementation by May 26, 2020, as well. Finally, notified bodies cannot renew 100% of the CE Certificates on May 25, 2020, to give manufacturers the full 4-year transition for certificates. Your certificate will expire based upon the certificate renewal cycle that is already established.

Required procedures for your EU MDR quality plan

You might not know that ISO 13485:2016 certification is not required for CE Marking of medical devices. Although ISO 13485 certification is the most popular way for companies to demonstrate quality system compliance with EU regulations, the actual requirement is to comply with the thirteen procedural requirements in Article 10 of EU Regulation 2017/745. Specifically, those thirteen procedures are:

1. Conformity assessment procedure / significant change procedure – SYS-025
2. Identification of safety and performance requirements (i.e., Essential Requirements Checklist) – FRM-038
3. Management responsibilities – SYS-003
4. Resource management, including suppliers – SYS-004 and SYS-011
5. Risk management – SYS-010
6. Clinical evaluation – SYS-041
7. Product realization, including design, production, and service – SYS-008, SYS-012, and SYS-013
8. UDI requirements – SYS-039
9. Post-market surveillance – SYS-019
10. Communication with competent authorities notified bodies and other economic operators – SYS-049 (new requirement)
11. Vigilance reporting, including serious incidents and field safety corrective actions – SYS-036 and SYS-020
12. Corrective and preventive actions – SYS-024
13. Monitoring and measurement of processes – SYS-017

Note: If you are interested in one of the procedures listed above that does not have a hyperlink, please contact me via email at rob@13485cert.com. The procedures are available, and the links will be provided during the next two weeks. The only exception is SYS-026. That is a new procedure in draft format, and it will be the subject of a future blog. Medical Device Academy will be revising each of the above procedures for compliance with EU Regulation 2017/745 in accordance with the MDR quality plan that we have outlined in this blog article. These procedures are all compliant with ISO 13485:2016, and updates for compliance with the EU MDR will be made available at no additional charge.

The priority of requirements for MDR quality plan

There are seven major changes required for compliance with the European Regulation 2017/745. These priorities are listed in order of highest to lowest effort and cost that will be required to comply, rather than the chronological order. First, some medical devices are being reclassified. Second, new CE certificates must be issued under the new conformity assessment processes. Third, technical documentation must be updated to meet Annex II of Regulation 2017/745. Fourth, post-market surveillance documentation must be updated to comply with Annex III of Regulation 2017/745. Fifth, specific documentation must be uploaded to the Eudamed. Specifically, manufacturers must upload UDI data, labeling, and periodic safety update reports (PSUR). Sixth, all economic operators must be registered with Eudamed and comply with Regulation 2017/745, or new economic operators will need to be selected. Seventh, quality system procedures will need to be updated to comply with Regulation 2017/745.

The implementation timeline for MDR quality plan

If any of your devices are being reclassified, you will need to implement all of the above changes before the May 26, 2020 transition date. For example, reusable medical instruments are currently Class I medical devices, and manufacturers utilize Annex VII of the MDD as the conformity assessment process. Under EU Regulation 2017/745, these reusable instruments will require notified body involvement to issue a CE Certificate. This is a lot of work to complete in 17 months (i.e., 513 days and counting), and notified bodies will have a large backlog of technical files to review for existing customers before they can review documentation for new customers.

If your company already has CE Certificates for your medical devices, and none of your devices are being reclassified, you will need to implement only the sixth and seventh items listed above before the May 26, 2020 deadline. Uploading information to Eudamed is likely to be extended beyond the May 26, 2020 deadline, and the transition may be staggered by risk classification–just as the US FDA did for UDI implementation in the USA. The second, third, and fourth changes listed above will require compliance before your existing CE Certificate(s) expire. The best-case scenario could be four (4) years after the transition deadline.