How to do business under MDR? A 12-step guide to preparing your company for the new regulations

The requirements brought in by the Medical Device Regulation have posed a serious challenge for many companies operating in the medical device industry. Adapting to the new legal reality requires a significant amount of time and effort. We have prepared a short guide for the transition process based on the EU recommendations to give you a clearer view of the situation.

The Medical Device Regulation (MDR) has been legally binding since May 26, 2021. In many aspects, the new regulations are considered an improvement on the Medical Devices Directive (MDD), which had been in force for almost 30 years. However, the MDR imposes stricter rules and applies also to products and issues that were not covered by the MDD. As a result, it poses a challenge to many medical companies as well as some businesses operating in the cosmetics industry.

It is worth to stress that the new regulations affect not only manufacturers but also three other groups of stakeholders identified in the MDR, namely: authorized representatives, importers and distributors, referred to as Economic Operators. Understanding the implications of the MDR is essential for many companies, so that they are able to comply with the new legal framework and stay competitive on the medical device market.

There is still some time left to fully adapt to the new business environment. The EU offers four transition periods for medical companies with regard to UDI implementation and dealing with certificates issued under the MDD. In no way does it mean that lingering is acceptable. A well-structured and determined approach to compliance is a must for companies that want to evolve in the new reality.

Implementing the MDR requirements in 12 steps

In order to help you successfully implement the MDR requirements, we have drafted a step-by-step guide for the transition process based on the EU recommendations. The process consists of 12 steps which – if performed properly – should safely drive you through the legal and practical intricacies of the new directive. Let’s give them a look.

1. Pre-assessment

Essentially, pre-assessment consists in the awareness of legal and business implications of the MDR, resulting in proper decision making and introducing necessary changes. It is crucial that you inform your management about the importance of compliance with the new regulations and make sure everyone in charge clearly understands the influence of the MDR on your business, budgeting, management and other operational issues.l

2. Gap analysis

As soon as the decision makers in your company are fully aware about the MDR requirements, you may start to prepare the gap analysis. It is advisable to begin with assessing the impact of the new regulations on the company’s current products, internal resources and the budget. Among other measures, this involves:

– checking the new classification rules, as some of the products may fall into different classes or subclasses under MDR,

– confirming the validity of your conformity assessment roles,

– determining the sufficiency of all the data collected so far in the new legal reality.

– reviewing the existing technical documentation based on the new requirements as well as crucial processes, such as post-market surveillance (PMS), vigilance, risk management (RM), to be able to handle documentation in accordance with the MDR.

3. Quality Management System (QMS)

In general terms, it is essential to verify which of the standards, procedures and SOPs currently employed by the company require updating in accordance with the new regulations. To comply with MDR it may also be necessary to create new procedures from scratch and incorporate them into your QMS. Another important obligation imposed by the new directive is to designate a person responsible for regulatory compliance. Basically, you have three options:

– to nominate a skilled expert from within the organization,

– to train an employee,

– to hire an expert.

The sooner you act, the better, as your expert will be involved in most of the activities during implementing the MDR requirements.

4. Legal entities

Although registration requirements for manufacturers haven’t changed a lot, the new policy – as opposed to the previous one – clearly specifies the rules for authorized representatives, importers and distributors. Consequently, you need to verify the companies in your supply chain with regard to their compliance with the MDR. Keep in mind that the new liability regulations may prompt some businesses to terminate particular activities in the medical device industry.

5. Portfolio verification

The cost of the transition from the MDD to the MDR environment is a crucial factor to consider. New standards and requirements regarding product classification, conformity assessment, PMS, technical documentation and so on impose additional expenses. Thus, an extensive review of your portfolio combined with a cost-benefits analysis should be an obvious step on your way to implement the new requirements. Obviously, it may result in a decision to limit the offer and stick only to selected products, ensuring their full compliance with the MDR. Mind that the portfolio review should include the verification of other parties involved in the supply chain that are liable according to the MDR rules.

6. Master implementation plan

Once you have completed the above steps, it is time to draft the master implementation plan. Basically, it is a road map comprising several subprojects, focused on critical compliance issues, such as clinical trials, documentation, PMS, and other. When planning, you should remember about the expiry dates of your certificates and focus on the products with the nearest expiry date.

7. Notified bodies

Another crucial step on the way to the MDR compliance is arranging the collaboration with the notified bodies. Their limited availability has for some time been an issue for medical device companies. So, it is strongly recommended that you contact the preferred institutions and check their capacity as well as determine the time expense necessary for performing the assessment. Only then you will be able to correctly plan all your activities.

8. Regulatory training

Adapting your business to the MDR standards requires training your staff and making them fully aware of the current regulations. It is best to conduct regulatory training gradually during the new requirements implementation process, so that at the final stage everyone involved is ready to perform their duties in accordance with the MDR norms.

9. Execution of the master implementation plan

The successful execution of the master implementation plan relies on the proper implementation of particular subprojects relating to clinical evaluation, technical documentation, PMS, vigilance, UDIs, labeling, supply chain and IT-related issues. The number and variety of subprojects depend on the specific circumstances. In any case, it is highly advisable to appoint a cross-functional project management team with clearly defined responsibilities. The team should be able to handle an overview of all the activities in all the (sub)projects covered by the master implementation plan. The purpose of this is to make sure that all the projects are consistent with one another, properly managed and effectively implemented.

10. Review of efficiency and effectiveness

Obviously, during the whole implementation process you should hold regular meetings to discuss the current project status, progress, issues, challenges and potential risks. Apart from the regular meetings, it is recommended to hold extra meetings with the decision makers to keep them up to date as to the development of the project. Of course, specific approach to the review depends on the applied methodology.

11. Notified body submission

If you haven’t been able to discuss all the necessary arrangements with the notified bodies this is the last call to do that. To avoid issues with the certification and CE conformity, make sure you are provided with detailed requirements regarding submission of the documentation, such as deadlines, terms, scope and type of data, and so on.

12. Ongoing monitoring

Apart from the monitoring applied as a part of PMS, vigilance and other standard processes, it is necessary to keep track of all the additional MDR-related updates and guidelines provided by the EU authorities. You need to make sure you properly understand all the regulations and you are following the best practices. This obligation should primarily fall on the person responsible for the MDR compliance. Last but not least, keep in mind that notified bodies are bound to perform both announced and unannounced audits. It is in your best interest to always be prepared for such an inspection.

If you have any doubts regarding MDR implementation and applying the correct procedures, don’t hesitate to contact us for consultation: info@luzernbaar.ch

Quality outsourcing – is it possible?

The use of quality assurance outsourcing solutions seems to be revolutionary to some, but is there really anything to be afraid of? Outsourcing is simply separating some of the functions a company conducts independently from the organizational structure and contracting them to other entities. This form of cooperation has been present in our daily lives and businesses for a long time. No one bats an eye at contracting an outside accounting company to meet their accounting needs. Not many companies decide to employ their lawyer while they can easily obtain legal services from a law firm. It’s just as easy to outsource challenges related to validation, qualification and measurement to an outside company specializing in these types of services. However, this topic causes many unnecessary fears and uncertainties. What benefits can transferring validation processes outside the company bring? In what situations should you investigate such support options? What should you look for when choosing the right subcontractor?

The priority of companies operating in the field of pharmacy and medical devices is in patient safety and the highest quality of products offered. That’s why tasks related to ensuring quality are one of the most critical in the entire company. So it’s no wonder that outsourcing these processes to an outside company can at first raise many questions. It’s good to seek answers to these questions and to learn about this cooperation model, which has been an important element facilitating dynamic development for western companies for many years.

In which situations can support from an outside company bring benefits? Is outsourcing an interesting solution only for small businesses?

One of the greatest advantages of receiving assistance from external consultants is that you use them only when you need them. If your company prepares a large project, additional specialists may be an excellent supplementation of your internal resources, in particular if the completion date of works determines the resumption or commencement of new production. The same applies in situations in which there’s a sudden need to re-qualify a machine or adjust to the comments made by an auditor. Instead of overloading a team that’s already busy with their ongoing tasks, it’s good to obtain support in certain areas.

This type of cooperation eliminates the burden of recruiting or training new candidates. In addition, you can rest assured that if a given employee is unwell or goes on leave, your subcontractor will suggest a replacement, which protects your work schedule and gives a feeling of security.

In small companies that don’t require full-time support from a validation specialist, the option of establishing cooperation with a contractor is ideal. You can take advantage of their support as you need, and that’s how you’ll be charged – only for the hours of consultations you use or the agreed part-time rate.

What should you look out for to be sure that the given contractor meets your expectations and performs the task you’ve entrusted with them adequately?

The references the given company has, are crucial in this matter. Relevant experience in the market and the opinions of our colleagues are valuable.

A good contractor will also provide you with information on the specific candidates who would execute the tasks entrusted to them. In addition to information on professional experience, you should also check the internal and external training the given company has provided for its employees. For you, this will guarantee that their knowledge and service performance are up to date with the latest industry standards.

The best contractors may recommend to you not only validation specialists but also professional team leaders and project managers. If you’re implementing a long and complicated project, or know that you’ll need ongoing support for a longer period of time (as is the case, for example, in maintaining a validated state), you can discuss the possibility of building a team that will comprehensively and professionally take over the assigned tasks, including planning, monitoring and preparing relevant summaries and reports.

A good subcontractor will present you with the appropriate procedures and solutions in this regard, but will also focus on the flexible tailoring of these to the specific needs of the project and business model of your company.

Another very important element is a reliable and feasible work schedule. An experienced partner will be able to, based on their knowledge and experience acquired in other projects, develop a plan containing information about the full scope, number of people, amount of time, and the equipment required to complete the project. They’ll also highlight the risks and crucial elements that you need to pay particular attention to. Based on this they’ll prepare their quote and the best form of billing for the progress of ongoing works.

The basis for this is the conversations that the future subcontractor conducts with the person who is responsible for the project and supplements the sending of technical documentation, plans or procedures currently in force in your company. So already at the outset, you must consider signing a confidentiality agreement.

The best introduction to preparing a detailed and precise quote can be an audit, during which the future contractor will check the state of documentation, procedures and applicable quality policy to then draw up a report with their opinion, list of potential problems and plan for further actions.

A company specializing in validation and qualification services should have its internal quality policy and be open to an audit by potential partners. If you don’t have time for meticulous inspection, you should send the service supplier a survey in which they will reply to key questions about the company itself as well as the quality policy it has in force.

In summary, if you decide to take advantage of the services of an outside company specializing in validation and qualification, you can significantly accelerate and improve quality assurance processes. A reliable subcontractor will help you to quickly implement a contract as per the schedule, optimize costs, eliminate the time and costs of recruitment, and flexibly react to market fluctuations. It can also turn out to be a real partner and provider of support. That’s why when choosing contractors, it’s important to check their experience, references, proposed candidates, schedule and approach to be sure that your collaboration will bring you optimal benefits.

Are you ready for the MDR? This is how new EU regulations may impact medical device producers

Medtech companies are facing major compliance challenges. As of May 26, 2021 new Medical Devices Regulation goes into effect and previous directives cease to apply. European Union expects full adherence across all its member states. Find out what this means for your company.

The importance of medical devices in the health systems across the world is rapidly growing. European Union, with its aging population prone to greater health risks, is seeking to further regulate the MedTech industry with a focus on patients’ safety. New rules contained in the Medical Devices Regulation (MDR) require increased vigilance in preventing medical device malfunctions and adverse events. In general terms, the emphasis is on product lifecycle – not merely getting it to the market. This means, obtaining approval is not enough. Manufacturers face the effort of retaining it as well.

Transition from the MDD to the MDR. Timelines and transition periods

The MDR is hardly news for the industry. It came into force on May 25, 2017, along with the in-vitro diagnostics regulation (IVDR), marking the start of the transition period for manufacturers distributing medical devices to EU markets to update their technical documentation and processes for the new requirements. The MDR was scheduled to apply from May 25, 2019 but the date was postponed by one year due to COVID-19-related disturbances.

New regulations repeal the rules comprised in three EU acts which have been in place for over 25 years: Medical Devices Directive (MDD, Directive 98/79/EEC and Active Implantable Medical Devices Directive (AIMDD). The latter is integrated into the MDR in an expanded form. The new law comes with 42 implementing acts and 12 delegating acts serving to either clarify or modify the regulations.

The shift in legal framework is mitigated by additional transition periods. New regulations allow for certificates issued under the MDD and AIMDD directives to remain valid until May 25, 2024 under specified conditions, while MDD devices already placed on the market may continue to be made available until May 27, 2025.

MDR: more efficient and transparent regulatory framework

Compared to the previous acts, MDR provisions have more substantial implications and introduce changes that will be deemed as laws – similarly to FDA medical device regulations. The document is also longer and more detailed (174 pages of MDR vs 60 pages of MDD). In essence, MDR is designed to align EU law with technological advancement and progress in medical sciences. It aims to provide an efficient and internationally recognized regulatory framework that will improve patients’ safety, at the same time creating transparent market for the medtech companies from around the world.

Key regulations and requirements for medical device manufacturers

The crucial requirements manufacturers need to comply with are covered in Article 10 of MDR titled “General obligations of manufacturers”. Key points of the new regulations include:

– a new device identification system based on a unique device identifier (UDI) that will facilitate traceability of medical devices,

– an obligation to mark devices with a device identifier (DI) and each batch or production series of the product with a production identifier (PI),

– an ‘implant card’ for patients containing easily available information about implanted medical devices,

– random inspections of manufacturers’ facilities after devices have been brought to the market,

– more rigorous controls on notified bodies, which will have to employ medically skilled people,

– an additional safety checking procedure for high risk devices, conducted not only by a notified body but also a special committee of experts,

– safety requirements for previously unregulated aesthetic products which pose a health risk to consumers, such as colored contact lenses not applicable for vision correction,

– the requirement to provide clinical evidence of medical device safety by manufacturers (as for medicines), especially in the case of higher risk classes.

EUDAMED – European database on medical devices

The MDR also establishes a set of databases covering, apart from registrations, post-market surveillance and risk management. Data on products, their IDs, manufacturers, related clinical investigations, are to be stored in and made accessible via EUDAMED – IT system developed by the European Commission to implement MDR, which will provide a living picture of the lifecycle of medical devices distributed in the European Union.

What are the main challenges for medical device producers?

Medical device companies may experience challenges with adapting to the new legal environment introduced by the MDR. Possible issues include:

– greater than budgeted costs of compliance,

– time and personnel engagement necessary for implementing changes,

– implications on the supply chain (business partner may decide to quit the EU market),

– additional, potentially costly responsibility with regard to data requirements,

– weighing the cost of compliance against revenue with a possible outcome of having to withdraw some products from the EU market.

There are plenty more issues to consider, both in terms of compliance and business goals, for medical device manufacturers facing the pressure of new regulations. If you wish to discuss the implications of MDR for your company, don’t hesitate to contact us via phone or email. Our experts will be happy to help you!

Who, when and how should prepare for the amendment of Annex 1?

Introduction

The pharmaceutical industry is characterised by numerous requirements governing its functioning. In my professional history, I have yet to meet an employee of this industry, who couldn’t wait to see an amendment to the Good Manufacturing Practice (GMP) requirements. The next edition of the legislative document is associated with investments, staff shortages, inconsistencies, work load of employees and endless hours spent on risk analysis. When operating in the pharmaceutical industry, it is worthwhile to be aware of GMP trends and not just only the current requirements.

Annex 1 (Manufacture of Sterile Products) to the EU GMP regulations (EudraLex Volume 4) is currently under revision. Do we already know when the finished document will be introduced into the legislation of the Member States? What final form will it be implemented? Unfortunately, we do not know that yet. Is it worth taking an interest in the current form of drafts? Definitely!

Which manufacturers should be interested in amending Annex 1?

Annex 1 is essentially about the manufacture of sterile forms of medicines. However, some of its provisions (e.g. requirements for room finishes, testing of the classification of premises, pressure cascades) are used by manufacturers of non-sterile medicines. This is because the remaining provisions of the law lack the necessary details and clear requirements. In the current draft, we can find unequivocal information that some of its provisions may be implemented in the quality system of a manufacturer of non-sterile medicines. This mainly concerns the products that are particularly vulnerable to contamination during production.

A company’s vast human resources are involved in the creation of a Quality Assurance System (QAS), which should meet all legal requirements, be easily understood by employees and allow the product to be marketed as efficiently as possible. In addition to the so-called hard law – uniform in the European Union, translated into national languages, there are also regulatory lower-ranking but more-detailed documents. These are Q&A issued by EMA, ISO standards, guides (e.g. issued by ISPE), WHO guidelines and many others. The latter documents often precisely describe how the vaguely written requirements of hard law can be met. Although the draft of Annex 1 is 40 pages longer (initially, it was 12 pages, and 52 pages were proposed in the final version), it does not necessarily mean a revolution in the currently operating plants. If we look in detail at the proposed provisions in the draft, we get the impression that the vast majority of these requirements have been already met by these companies. The new provisions combine the requirements of existing law with components of so-called soft law, containing both specific and working details.

What modifications to the requirements have been proposed in the current draft of Annex 1?

Apart from the more precise provisions, the following changes should deserve special attention:

A much greater share of risk management methods are established. Every activity related to sterile production should be designed using risk management methods. Risks should also first be limited by reducing the harmfulness and frequency of errors, and only in the second wave should the methods of error detection be increased.
A new type of risk analysis has been introduced – Contamination Control Strategy (CCS). This document is quoted in a new draft in many different areas. CCS should be implemented throughout the plant to define all critical control points and assess the effectiveness of all control measures (design, procedural, technical and organisational) and monitoring measures related to contamination control. All contaminants, including microbiological, endotoxins, pyrogens and particulates, would be the subject of this document. It has been clearly stated that the document is to be “living”, i.e. it should change as the knowledge and awareness of the manufacturer’s personnel increases.
Tests were imposed to visualise airflows. Visualisation of the effectiveness of pressure cascades, RABS systems, and tightness of premises (Containment leak testing) will be required. Previously, these requirements were part of EN ISO 14644-3. Films from the aforementioned smoke tests should cover both resting and operating conditions. However, the conclusions from the tests carried out should be taken into account when designing microbiological tests (including routine monitoring and qualifications).
The concepts of “at-rest” state and “in operation” state have been developed. The “in operation” state should include the maximum number of personnel and the ongoing process or its simulation and the worst case of processes conducted in the room. Seemingly intuitive recording entails additional work. It involves selecting the worst case during the “in operation” tests and proving that such conditions were maintained during the PQ execution.
Minor differences have been introduced in the scope of airborne particle testing during qualification and monitoring. The requirement to set empirical limits for particles in zone D during operation merits interest. The current Annex 1 requires only testing of the particles in class D at rest.
A requirement has been introduced to determine the number of sampling points. It should be based on a documented risk assessment, including classification results, air visualisation studies and process and operational knowledge.
The minimum scope and frequency of re-qualification of class-designated premises has been set.
In addition to the information on the rotation of disinfectants, the use of sporicidal was recommended.
The effectiveness of disinfectants must be proven in a worst case validation. The scope of this validation is very similar to the microbiological part of the validation of cleaning of production facilities and cannot be replaced by simple monitoring.
Clothing management processes in clean rooms should be qualified.

What to do with knowledge of trends in GMP?

Is it worth preparing yourself for the new Annex 1 draft right now? In fact, this is still a law project, which is still being evaluated by organisations and associations of industry professionals. Once a common version has been developed, the final wording may be subject to significant changes. By implementing the proposed solutions, manufacturers risk wasted resources and perhaps found inconsistencies with the current law. Therefore, one of the solutions is to wait for the completion of the legislative process amending Annex 1.

The second possibility is to implement certain solutions right now. Certainly not those which are contrary to the current law. However, it is worth taking into account the evolutionary change in the QMS documents (and, consequently, in the practice of the production plant) already now. During reviews and revisions due to other needs, procedures can be developed in accordance with both the current law and the new draft of Annex 1. A convenient tool to control the whole process of adjusting the plant may be the so-called “Traceability matrix”, where each legal requirement will be assigned to system, organisational and hardware actions. This would make it possible to assess the compliance of the plant’s QMS with the proposed new law and assess the scale of possible work in the event of the need to adapt to the new guidelines. It is worth being aware of the likely legal changes, especially before investments (planned for a dozen or so years) and the qualifications of new areas. By following both the requirements in force and the proposed legal changes, investments will avoid, for example, repetition of qualifications. The risk of this approach is the involvement of human and financial resources despite the lack of formal requirements. The profit may be the spreading of the revolution in the QMS and optimisation of investments.

Annex 1 is being amended. The list of organisations that are currently commenting on the content of the draft is impressive and gives hope that the final wording of the new legislation will be precise and easily understood by manufacturers. It is not certain when the new rules will exactly come into force, but it is a good idea to take an interest in them now. Regardless of whether the manufacturer, by taking a business decision, will already begin to implement elements of the legal proposal or will wait for legal changes, it is worth being aware of the likely legislative changes which will take place in the near future.

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Category: Quality Assurance