Boumans Regulatory Consulting B.V.

𝗛𝗼𝘄 𝗱𝗶𝘀𝗮𝗽𝗽𝗼𝗶𝗻𝘁𝗶𝗻𝗴... After spending months of hard work, the notified body completeness review of your documentation results in... nothing... However, I think my client may get over this slightly mellow response and celebrate passing this first hurdle. The next step consists of the assessment of the documentation. I wouldn't be surprised if that feedback is similarly mild. This challenge 'only' concerns a notified body opinion ( #NBOp ) according to #Article_117  for an integral drug-delivery device, but this process is new to this organization. It was a pleasure helping this excellent team creating a solid set of documentation.

𝗣𝗥𝗥𝗖 𝗠𝗮𝘀𝘁𝗲𝗿𝗰𝗹𝗮𝘀𝘀! After I found a serious non-conformity, my contact at the company said: ‘I agree this is a problem. Could you write your report in such a way that it raises awareness at management level, while at the same time, the authorities will not be alerted?’ If you work as a #PRRC, what do you think? • Do you think this an appropriate question for a PRRC? • Would you award this request? • Do you think there could be risks involved if you do, and if don’t? • Can you prepare for such a question? If are not sure about these answers, you may need additional PRRC training. Join me in Rotterdam; first at the #𝗧𝗢𝗣𝗥𝗔 𝗦𝘆𝗺𝗽𝗼𝘀𝗶𝘂𝗺 𝟮𝟬𝟮𝟰 on 1 and 2 October, next on a special 𝗣𝗥𝗥𝗖 𝗠𝗮𝘀𝘁𝗲𝗿𝗰𝗹𝗮𝘀𝘀 𝗼𝗻 𝟯 𝗢𝗰𝘁𝗼𝗯𝗲𝗿. You have to register separately for this masterclass and there are only 20 places available. This masterclass will dive deep into how you best prepare for the challenges a PRRC may face. We will look into many things Article 15 or MDCG Guidance 2019-7 don’t address, but that are highly relevant for your role as a PRRC. This workshop is open to anybody who wants to learn about the role of the PRRC, it is not necessary to join the TOPRA Symposium. Further details: Location: 𝗣𝗼𝘀𝘁𝗶𝗹𝗶𝗼𝗻 𝗖𝗼𝗻𝗳𝗲𝗿𝗲𝗻𝗰𝗲 𝗖𝗲𝗻𝘁𝗲𝗿 (same location as the TOPRA Symposium); Time: 𝟵:𝟬𝟬 – 𝟭𝟳:𝟬𝟬 𝗖𝗘𝗧; Catering: drinks, some snacks, and lunch are included; You will receive a certificate of participation; Costs: € 475 excluding VAT And you will get the 𝗦𝗨𝗣𝗘𝗣 𝗣𝗥𝗥𝗖 𝗧-𝘀𝗵𝗶𝗿𝘁! Registration by sending an email to: 𝗥𝗼𝗻𝗮𝗹𝗱@𝗯𝗼𝘂𝗺𝗮𝗻𝘀𝗰𝗼𝗻𝘀𝘂𝗹𝘁𝗶𝗻𝗴.𝗰𝗼𝗺

𝗛𝗲𝗹𝗽 𝗻𝗲𝗲𝗱𝗲𝗱: 𝘾𝙖𝙣 𝙖𝙣𝙞𝙢𝙖𝙡𝙨 𝙗𝙚 𝙘𝙤𝙣𝙨𝙞𝙙𝙚𝙧𝙚𝙙 𝙙𝙚𝙫𝙞𝙘𝙚𝙨? There are stories about dogs that can smell certain medical conditions. I have seen some scientific work about animals used to smell for certain biomarkers and it appears they can be more sensitive than currently used gas analysers. This opens up the use of those animals to detect certain markers that may otherwise not be noticed. Let's take a fictional example, where a dog is used to smell certain samples of patients to see if they are developing pancreas cancer. Would that dog be an IVD? If so, can it be certified? If not, how should this be regulated? An IVD is defined as a medical device which is used for in-vitro diagnostic procedures. This is clearly an in-vitro diagnostic procedure, so the question is if the dog is a medical device. If we look at the definition of a medical device, it states that this is 'any ... article... intended by the manufacturer to be used... for ... diagnosis...'. In general, a dog is considered a commodotie and it can be traded. It looks like it can be seen as 'an article'. Of course, the #MDR does not apply for a device consisting of, or incorporating, viable animal tissue (see Article 1(6f)). But the question is not about the applicability of the MDR. In MDR Article 1(6a) IVDs are excluded from the scope of the MDR, because they are covered in the scope of the #IVDR. So, if something contains viable animal tissue, it may still be in the scope of the IVDR. The IVDR does not exclude viable animal tissue. From that perspective, the dog could be seen as an IVD. However, I find this hard to believe. There is an uncomfortable 'feel' to considering dogs as an IVD, let alone the challenges related to certification. And if it is not an IVD, what is it and how should this be regulated? Dear network, what do you think? Please leave your comments below. I am looking forward to a great #borderline discussion...!

𝗪𝗼𝗿𝗸 𝗹𝗶𝗸𝗲 𝗮 𝗽𝗿𝗼! Of course I use templates when helping companies preparing their technical documentation for #MDR certification. Over the years, I created a set of templates that communicate with each other. The conclusions of one document can be found in the scope of the next. The look and feel the same, they tell the same story. The narrative is such, that a reviewer will be guided through the demonstration of compliance, finding answers where expected and at the moment they are needed. These templates are combined with nice tools. If a company is looking for a notified body, I use my own profiling tool. I have an updated set of harmonized standards, Soon I will be able to search all MDCG guidance documents. And more. Now here is an interesting question for you: 𝘄𝗼𝘂𝗹𝗱 𝘆𝗼𝘂 𝗹𝗶𝗸𝗲 𝘁𝗼 𝗵𝗮𝘃𝗲 𝗽𝗲𝗿𝗺𝗮𝗻𝗲𝗻𝘁 𝗮𝗰𝗰𝗲𝘀𝘀 𝘁𝗼 𝘁𝗵𝗲𝘀𝗲 𝘁𝗼𝗼𝗹𝘀 𝗮𝗻𝗱 𝘁𝗲𝗺𝗽𝗹𝗮𝘁𝗲𝘀? Just check a box. Here are the options: 1. No. We have some good tools at my work and I don't see what value a seasoned expert could add. 2. Yes, but only if this is offered for free. 3. Yes, and I would love paying 49 Euros per month for it. 4. Yes, and I would even pay 99 Euros per month for it. Just let me know what you think this would be worth to you. Keep in mind, that a higher price will encourage me to keep improving these tools and templates. It would also allow me to spend more time on training and other ways of improving how we, the regulatory affairs community, ensure compliance. Let me know what you think about this in the comments below.

If there are elections, I help as a volunteer. I can recomend anybody to do that. It means that you can serve our precious democracy in the most direct way and you can see for yourself how much efford is put into making every vote count. During the day, we make sure that at the poling station everybody can vote without anybody interfering. At the picture I am checking if the invitation to vote is genuine, it belongs to the person carrying it (ID card, drivers' license, or passport required) and I check if that identidy document is still valid. It results in frequent remarks like: 'Is this the first time you vote?', 'Happy birthday', and 'Do you know it will expire later this year?' After the polling ended, we had to count. That took us past midnight. Here too, we had to sort the votes, count them, count again, compare total numbers with all votes that have been cast and the next day, all these votes have been counted again and again been added up and checked. Every time I help, I feel proud of the robust system we have and all those people that volunteer to help. Polling stations are public places, where you can see for yourself if everything is done according to the law. You can even witness how the counting is done, and frankly, around midnight, we would have appreciated a bit of an audience. Please vote whenever you can, starting with the European Parliament elections. By the way, the shirt that promotes all political colours, is from Wolff Blitz in Rotterdam.

What would you like your notified body to say during your first call? Notified bodies are allowed to offer a 'Structured Dialogue'. For obvious reasons, they cannot do consulting. But it helps if you know that for certain concepts regarding #MDR or #IVDR you are on the same page as your #NotifiedBody. For many companies, the #StructuredDialogue is the first real contact they have and this is the moment to make a first impression. Recently, I had such a call in which the notified body said they could see the team had done their homework. The questions of this client were formulated in such a way, that in most cases they just said: 'Yes, we agree to all these assumptions and your conclusions.' If you like to make a similar first impression to your notified body, just reach out.

Dear Network: I NEED YOUR HELP (again...) One of my clients needs a proper usability study plus the evaluation report done in a relatively short time. Only reach out if you work for an EU based organization and if you can act swiftly. Reward: my eternal gratitude and possibly an interesting project in which we will be working together.

LAST CALL! LAST CALL! The online Outsourced Manufacturer #PRRC training starting 14 May is about to close. This is your last opportunity before the Summer break! At RAPS Euroconvergence I have been asked several times what it is that makes this training special. Well, just think about the scenario where you notice a non-conformity. Now you have to report about it. Will you barge into a board meeting and throw this issue on the table, or would you prefer an approach where you communicate the same message, but this time to managers that are prepared to hear you out and discuss options in a productive way. If you prefer a smoother ride, you need to prepare. The online PRRC training courses of the PRRC Academy offer you just that, with seven practical templates (procedure, appointment letter, justification, assessment tool, annual plan, annual report, and interim report) and the opportunity to practice on scenarios that are based on real events. Use the link in the comments, or just reach out to me directly: [email protected] Three Super PRRCs at RAPS Euroconvergence in Berlin:

Super #PRRCs United! I will be at the #RAPS Convergence in Berlin next week. If you earned the T-shirt, join me at a photoshoot. Let's see if we can break the World record of Super PRRCs in one picture (currently 10)! Reach out for the exact time and place. Note that anybody can buy these shirts, the mandatory training will then be provided for free.

Outsourced PRRCs adding value to small companies   Manufacturers of medical devices and IVDs intended for the EU market must appoint at least one Person Responsible for Regulatory Compliance (PRRC). There are two ways of doing this: 1.       Just appoint someone who more or less meets the criteria and have that box checked; 2.       Make this legal requirement into an opportunity to add extra value to the organization.   If checking boxes is all you want to do, just appoint anybody with sufficient education and experience and hope that nothing serious will happen with regards to compliance. And you will probably get away with this, because the majority of manufacturers don’t have major issues. From currently available data, only a handful of companies get into serious trouble every month out of a population of about 50,000. The odds are in your favor.   However, you may also use this as an opportunity to improve the quality of your company. Especially in the case of small companies, this can be challenging. By hiring an external consultant who is offering outsourced PRRC services, you may get a fresh pair of eyes looking at your company and they will bring a lot of experience and expertise with them, that would be difficult to find in a full time staff member. Their experience may help you in making the right decisions. However, make sure you distinguish between the role of a consultant and that of a PRRC. A PRRC opinion may be of legal relevance while a recommendation by a consultant does not have to be shared with the authorities. So, if your PRRC is also your consultant, make sure you know whose opinion you are asking.   There are some issues you need to take into account when working with outsourced PRRCs: 1.       Do your due diligence and check if they have the expertise that will bring an added value to your organization. 2.       Make sure you don’t mix the roles of the PRRC and that of a consultant. If the PRRC is also the consultant, don’t let this person check their own work. 3.       Allow the PRRC to be your eyes and ears on the work floor. Even if they are outsiders, they may be able to detect potential issues long before they become a problem.   Paraphrasing a famous Dutch advertising campaign: the PRRC Academy recommends small companies to hire at least one external PRRC, who should preferably be trained by the PRRC Academy.   The online training for outsourced manufacturer PRRCs on 14 and 21 May, 16:00 – 18:00 CET, still has a few places open. Because of the high level of interaction, there is a maximum of six participants.   See the link in the comments for details.