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On 22 January 2018, the European Commission released a notice to stakeholders concerning the United Kingdom’s (“UK”) possible withdrawal from the EU.
The notice presents the steps that manufacturers of medical devices and IVDs should take to avoid negative after-effects following Brexit.
UK Manufacturers and Importers and EU-based Distributors
The Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR) provide that manufacturers, importers, distributors and authorized representatives fall within the definition of an “economic operator”.
After Brexit, the UK would become a third country. The notice provides that any UK manufacturer or importer or authorized representative (AR) will no longer be perceived as an economic operator established within the EU after Brexit. Moreover, EU distributors of UK medical devices or IVDs based in the remaining Member States will become importers of third-country products thereafter. Consequently, they will have to comply with specific obligations, which are different from those of a distributor.
Authorized Representatives
According to the MDD/MDR and the IVDD/IVDR, manufacturers of medical devices imported into the EU from a third country are required to appoint an authorized representative established in the EU (“European Authorised Representative” – EU AR).
It is currently estimated that approximately 50% of the European Authorized Representatives in the medical devices industry are based in the UK. After 29 March 2019 (the date set for Brexit), authorized representatives established in the UK will not be considered as European Authorised Representatives and will, therefore, be unable to fulfill this role on behalf of non-EU legal manufacturers.
The MDR and the IVDR also introduce a new requirement for manufacturers and EU AR’s to have at their disposal at least one qualified person responsible for regulatory compliance (‘PRRC’/QP) who should be based in the EU. [Article 15].
Non-recognition of UK-Notified Bodies
According to the document, following the anticipated withdrawal of the UK from the EU, UK Notified Bodies will not be considered EU Notified Bodies. They will be erased from the European Commission’s Nando database, which includes the details of all Notified Bodies in the EU. As a result, UK Notified Bodies will no longer be permitted to provide conformity assessment services in accordance with EU product legislative framework and issue related CE Certificates of Conformity.
Medical devices which are CE marked by UK legal manufacturers and are placed on the EU market will, after Brexit, need to have related CE Certificates of Conformity issued by a Notified Body licensed by the competent authorities of one of the 27 EU Member States.
Legal manufacturers of medical devices that currently hold a CE Certificate of Conformity issued by a UK notified body yet intending to continue marketing their devices in the EU will be required to choose one of two solutions.
- They will need to seek a CE Certificate of Conformity issued by a notified body licensed in one of the remaining EU Member States.
or
- They will need to transfer the technical file and related to the medical device and the existing CE Certificate of Conformity issued by a UK notified body to a notified body licensed in one of the remaining EU Member States on the basis of a contractual arrangement between the manufacturer, the UK Notified Body and the Notified Body of one of the remaining Member States.
Please contact our office for more information.
PRRC - ‘Person Responsible for Regulatory Compliance’ (MDR/IVDR: Article 15)
Written by QNET GroupWithin the EU regulations – MDR: (EU) 2017/75; and IVDR: (EU) 2017/746 - companies are obliged to have a qualified regulatory expert on staff or at their disposal to ensure the company is meeting EU requirements.
This (new) role of ‘Person Responsible for Regulatory Compliance’ [PRRC] is defined in the EU MDR and IVDR (Article 15).
The PRRC is different than an EU Authorized Representative
The PRRC does not replace the European Authorized Representative (EU AR). The EU AR must be located in the EU and meet requisite qualifications that are well defined in the MDR and IVDR. The EU AR’s name and address must appear on labeling. However, the EU AR does not have nearly as many responsibilities as those assigned to the PRRC in Section 3, Chapter 1, Article 15 of the EU MDR and EU IVDR.
An abbreviated list of PRRC responsibilities:
- Check conformity of devices with QMS procedures before they are released;
- Make sure all Technical Documentation and Declarations of Conformity are up to date;
- Ensure all post-market surveillance and reporting obligations are met.
Qualifications of the Person Responsible for Regulatory Compliance
The EU MDR and IVDR stipulate that the PRRC must have:
- Requisite expertise in the field of medical devices, +
- A university degree, diploma, or some other formal qualifications, +
- At least one year of experience in regulatory affairs or quality systems management related to medical devices, or
- If no university degree, diploma, or other qualification, must have four years of professional experience in regulatory affairs or quality systems management related to medical devices
Medical device companies don’t need a PRRC on staff if…
What happens if a company outsource all of regulatory compliance?
Article 15 offers some relief to “micro and small” enterprises exempt from having a PRRC on staff. Basically, you are exempt from having a PRRC on staff if, at the close of your most recent accounting period, you had:
- Fewer than 50 FTE global employees, and
- Under €10 million in sales/turnover (global revenue, not just EU)
You’ll notice that there is no exemption for manufacturers that are only marketing low-risk devices in Europe. All companies need a PRRC. European Commission Recommendation 2003/361/EC spells out the definition of “micro and small” companies as mentioned above.
Can the PRRC be outsourced? Can it be more than one person?
If your organization do meet the definition of a micro/small company, you can outsource this role as long as the person to whom you’re outsourcing the role is qualified and “permanently and continuously” at your disposal.
If your organization is located outside the EU, your Authorized Representative (EU AR) could fulfill the PRRC role for you. It must be justified and evidenced that your PRRC is permanently and continuously at your disposal if your facility is located outside the EU. It should also be noted that a PRRC is also required for the Authorized Representatives according to Article 15(6). If you have appointed an importer or distributor as your Authorized Representative, you need to justify and to evidence the PRRC qualifications and responsibilities!
If a micro/small company does not have someone with the regulatory expertise on staff. This means you may need to contract an registered and recognized regulatory service provider as us to act as your PRRC. Remember, your outsourced PRRC needs to be qualified to handle European medical device regulatory compliance. After all, your PRRC will be considered a critical supplier and you should have appropriate agreements in place. As part of your supplier qualification process, this also includes contractors or consultants supporting your compliance efforts. If you outsource your PRRC, remember the stipulations above that this individual will be responsible for compliance with procedures, Technical Documentation, and postmarket surveillance obligations. This outsourced PRRC must be permanently available and integrated into the organization in a manner that allows you to fulfill the requirements of the EU MDR/IVDR.
Contact us if you do need more information and or a PRRC contract
Ondersteuning bij implementatie ISO 13485:2015
Productenten en gelieerde organisaties van medische hulpmiddelen en of biotechnologie worden steeds meer geconfronteerd met striktere eisen vanuit de Europese en Amerikaanse wetgeving. Een goed en stabiel kwaliteitsmanagement is van belang om in staat te zijn om nieuwe eisen effectief en efficiënt te implementeren. Een voorbeeld hiervan zijn de nieuwe ISO 13485 die wellicht ergens in kwartaal 2 van 2016 gepubliceerd zal worden. In deze periode zal dan ook de nieuwe Europese medische richtlijnen van kracht worden (MDR en IVDR). Overgangsperiode voor de ISO 13485 en de MDR zal drie jaar zijn. Nieuwe eisen zijn bijvoorbeeld UDI, PMCF, scrutiny procedure.
MRM kan u ondersteuning bieden tijdens dit transitieproces.
ISO 13485:2016 & MDR
Zowel de 'nieuwe' ISO 13485:2016 en de MDR brengen significante wijzigingen met zich mee! Door tijdig en proactief de nieuwe eisen in uw management en product systeem te implementeren zal tot gevolg hebben dat uw organisatie succesvol geïnspecteerd zal worden door onze nationale overheden (bijvoorbeeld IGZ) en notified bodies. Hiermee bent u dan verzekert dat de CE markering van uw producten aantoonbaar aan de nieuwe eisen voldoen. Het risico dat uw CE en of ISO certificaten opgeschort worden weet u zo te voorkomen.
GAP Analyse
Indien gewenst verrichten we graag een GAP analyse, zodat U
- in staat bent om eventuele omissies vast te stellen,
- duurzame verbetertrajecten kunt initiëren, en
- nodige kennis en expertise in te huren om u te ondersteunen.
We bieden een service programma die uw organisatie helpt bij ontwikkeling, implementatie en onderhoud van een robuust kwaliteitmanagementsysteem.
Waarom MRM?
We hebben meerdere organisaties ondersteund bij het opzetten, en het onderhouden van kwaliteitsmanagementsystemen. We zijn in het bijzonder gericht op de gezondheidszorg, biotechnologie en medische technologie.
Door onze doelgerichte praktische benadering door onze adviseurs met deskundige kennis van de markt zijn we in staat om ons te onderscheiden. We hebben de ambitie om duurzame oplossingen te bieden, zodat uw investeringen terugverdiend worden. Juist door deze benadering kan het voorkomen dat we minder competitief zijn, maar onze oplossingen wel duurzamer en effectiever zijn.
We zijn overtuigd dat de door ons ontwikkelde methodologie van het overdragen van kennis en expertise naar uw medewerkers en organisatie werkt. Daarom accepteren we onder bepaalde condities 'no cure no pay'.
(Tailor-Made)
Together with our CRO-partner in Lisbon (Potugal) we offer tailor-made trainings to meet the needs of different group of clients. Depending on the project we can also combine training sessions with consultancy services in developing research projects.
Training courses can take different formats:
- On-site courses
- Individual courses
- Workshops
- Courses accompanied by consultancy
- Post-grad or master’s modules
- Seminars and lectures during congresses and meetings
Course venues:
- At your company or the location of your choice anywhere in the world.
- Eurotrials classrooms in Portugal, Brazil, Chile or Argentina
Examples of tailor-made courses:
- Development of Scientific project training programme
- Biostatistics in SPSS with interpretation of scientific articles
- Interpretation and presentation of clinical study results: clinical study reports
- Quality of life scales
- Sample size in polynomial and logistic regression analysis in health research
- Key points in the design of a clinical study in a real-life setting
- Statistical methods: the assessment of an abstract
- Writing and reviewing scientific articles
- Clinical epidemiology in multiple sclerosis: analysis and interpretation of scientific publications results
- Site Capacity building and coordination of clinical research
- Basic tools in the interpretation, construction and presentation of statistical results
- Good Clinical Practices training
- Good Clinical Practices training: refreshment
- Clinical Trial– current and future legal framework
- Interpretation of effect measures in clinical trials
- Principles in statistical analysis in clinical studies
- Clinical research centres: new challenges
Please contact This email address is being protected from spambots. You need JavaScript enabled to view it. for more information.
Zie tekst Engelstalige versie voor toelichting.
NB Trainingen kunnen zowel in het Nederlands als ook in de Engelse taal gegeven worden.
10 things that everyone should know
1. What does the revision of ISO 9001 mean for your organisation?
It’s actually been a long time since the standard was last revised with any significance and a lot has changed in that time. The potential organisational impact of the revised ISO 9001 is dependent upon how your organisation and incorporated QMS has evolved in time. Factors such as
- the maturity and complexity of the existing ISO 9001:2008 management system,
- the existence of other management systems (such as ISO 13485),
- the global environmental management system standard (i.e. OHSAS 18001), and
- the organisation’s current evaluation and management of risk
will all heavily influence in the degree of change that your organisation will need to undertake in order to meet the requirements of the ISO 9001:2015.
2. Annex SL
The introduction of Annex SL, which establishes a consistent structure featuring 10 clauses as well as common terminology and definitions applicable to all ISO Management System Standards (MSS), is probably the biggest change to the ISO 9001:2015. As organisations begin to understand and appreciate the value of different management systems all speaking a common language, thereby making MSS integration easier, it will be organisations and - and in turn the consumer - who stand to be the true beneficiaries.
3. Process-Based Approach
The ISO 9001:2015 contains many references across several clauses to organisations placing a greater emphasis on applying a process-based approach to their management system.
4. Risk-Based Approach
The incorporation of Annex SL into ISO 9001:2015 now drives a risk-based approach to thinking and acting. The requirements under a risk-based approach affect quality planning and now incorporate much of what was previously referred to as “Preventive Action”. Now an organisation will need to determine the risks and opportunities that need to be addressed to give assurance that the QMS can achieve its intended results. Many organisations already have risk-based thinking and planning in many parts of their organisation which may or may not have been connected to the QMS in the past. This greater focus on risk will mean that an organisation will need to demonstrate how this requirement is met. The extent and formality of the approach needed in a particular organisation will - of course - be influenced by its context.
5. Leadership
The requirements relating to the relationship between the role Top Management play in creating and supporting an effective QMS have been enhanced. There are now more areas where Top Management needs to demonstrate their involvement and engagement with the quality management system including accountability for the effectiveness of the QMS and ensuring integrated with the overall business processes.
6. Context of the Organization
This is new and has two distinct elements.
Firstly, context requires an organisation to determine the internal and external issues and requirements that can impact on the planning of the quality system. Context becomes an important consideration and helps to ensure that the management system is designed and suitably adapted for a specific organisation. This helps provide the right focus, approach and balance to the different elements of the management system rather than the same generic approach across all organisations.
The second element is the consideration of relevant interested parties. There is now a requirement to determine their requirements and ensure these are monitored and reviewed as these now form primary inputs into the design of QMS.
7. Knowledge
An organisation will now need to consider what knowledge it needs to achieve conformity of products and services along with how it will develop, maintain and retain such knowledge.
8. Control of externally provided products and services
Formerly known as Purchasing, this clause has been retitled to make it clear that the requirements apply to both physical product and services related to the end product of the organisation. Whilst not specifically a new requirement, there has always been some confusion around certain categories of externally provided products and services whether this has been through an associate company, joint venture or outsourced activity. Now it is clear that however provided, an organisation will need to apply a risk-based approach and determine the type and extent of controls necessary.
9. Transitioning
Current information from ISO shows that organisations will have three years from publication to transition to the new standard, so they can choose to transition at any point within this period. Some may choose their next certification cycle, although many will want to be ‘among the first’ given the increased functionality that ISO 9001:2015 will deliver, along with the bonus of a clear commitment to best practice being demonstrated to their interested parties. Starting the transition planning early, including setting and communicating a transition date will enable you and your organisation to pro-actively manage the transition at your pace.
10. Next Steps
Organisations should start by obtaining a copy of the ISO standard and focus on the areas that are completely new or have been revised. Those are the areas that are likely to be included in any transition plan. Also, make sure that quality managers and internal auditors understand the differences that Annex SL will bring to the QMS and any other management system standards in the organisation.
Ensure that when selecting a consultancy firm, they not only understand the ISO 9001:2015, but more importantly, understand what this ISO means to the QMS and the wider organisation. Engage a consultancy firm to find out how a gap analysis and training on specific areas of ISO 9001:2015 can be of benefit to your organisation.
Finally, ask MRM to support you in formalising a transition plan and process and ensure that top management is involved from the start.
Summary
Remember that the ISO 9001
- is important for any standard
- does have a significant amount of changes through the incorporation of Annex SL’s core text and high level structure.
In the ISO 9001:2015 is a greater emphasis on risk-based thinking as a basis for the management system, more focus on achieving value for the company and its customers, increased flexibility regarding use of documentation, and a more approachable structure for service businesses.
We've developed a short knowledge test to give you a quick insight of some changes. We challenge you to perform this test as a start of the transfer plan ISO 9001:2008 > ISO 9001:2015.
Do not hesitate contact us if you as organization need assistance in defining the transition and or implementation plan.
Link On Line Knowledge Test ISO 9001:2015
10 things that everyone should know
1. What does the revision of ISO 9001 mean for your organisation?
It’s actually been a long time since the standard was last revised with any significance and a lot has changed in that time. The potential organisational impact of the revised ISO 9001 is dependent upon how your organisation and incorporated QMS has evolved in time. Factors such as
- the maturity and complexity of the existing ISO 9001:2008 management system,
- the existence of other management systems (such as ISO 13485),
- the global environmental management system standard (i.e. OHSAS 18001), and
- the organisation’s current evaluation and management of risk
will all heavily influence in the degree of change that your organisation will need to undertake in order to meet the requirements of the ISO 9001:2015.
2. Annex SL
The introduction of Annex SL, which establishes a consistent structure featuring 10 clauses as well as common terminology and definitions applicable to all ISO Management System Standards (MSS), is probably the biggest change to the ISO 9001:2015. As organisations begin to understand and appreciate the value of different management systems all speaking a common language, thereby making MSS integration easier, it will be organisations and - and in turn the consumer - who stand to be the true beneficiaries.
3. Process-Based Approach
The ISO 9001:2015 contains many references across several clauses to organisations placing a greater emphasis on applying a process-based approach to their management system.
4. Risk-Based Approach
The incorporation of Annex SL into ISO 9001:2015 now drives a risk-based approach to thinking and acting. The requirements under a risk-based approach affect quality planning and now incorporate much of what was previously referred to as “Preventive Action”. Now an organisation will need to determine the risks and opportunities that need to be addressed to give assurance that the QMS can achieve its intended results. Many organisations already have risk-based thinking and planning in many parts of their organisation which may or may not have been connected to the QMS in the past. This greater focus on risk will mean that an organisation will need to demonstrate how this requirement is met. The extent and formality of the approach needed in a particular organisation will - of course - be influenced by its context.
5. Leadership
The requirements relating to the relationship between the role Top Management play in creating and supporting an effective QMS have been enhanced. There are now more areas where Top Management needs to demonstrate their involvement and engagement with the quality management system including accountability for the effectiveness of the QMS and ensuring integrated with the overall business processes.
6. Context of the Organization
This is new and has two distinct elements.
Firstly, context requires an organisation to determine the internal and external issues and requirements that can impact on the planning of the quality system. Context becomes an important consideration and helps to ensure that the management system is designed and suitably adapted for a specific organisation. This helps provide the right focus, approach and balance to the different elements of the management system rather than the same generic approach across all organisations.
The second element is the consideration of relevant interested parties. There is now a requirement to determine their requirements and ensure these are monitored and reviewed as these now form primary inputs into the design of QMS.
7. Knowledge
An organisation will now need to consider what knowledge it needs to achieve conformity of products and services along with how it will develop, maintain and retain such knowledge.
8. Control of externally provided products and services
Formerly known as Purchasing, this clause has been retitled to make it clear that the requirements apply to both physical product and services related to the end product of the organisation. Whilst not specifically a new requirement, there has always been some confusion around certain categories of externally provided products and services whether this has been through an associate company, joint venture or outsourced activity. Now it is clear that however provided, an organisation will need to apply a risk-based approach and determine the type and extent of controls necessary.
9. Transitioning
Current information from ISO shows that organisations will have three years from publication to transition to the new standard, so they can choose to transition at any point within this period. Some may choose their next certification cycle, although many will want to be ‘among the first’ given the increased functionality that ISO 9001:2015 will deliver, along with the bonus of a clear commitment to best practice being demonstrated to their interested parties. Starting the transition planning early, including setting and communicating a transition date will enable you and your organisation to pro-actively manage the transition at your pace.
10. Next Steps
Organisations should start by obtaining a copy of the ISO standard and focus on the areas that are completely new or have been revised. Those are the areas that are likely to be included in any transition plan. Also, make sure that quality managers and internal auditors understand the differences that Annex SL will bring to the QMS and any other management system standards in the organisation.
Ensure that when selecting a consultancy firm, they not only understand the ISO 9001:2015, but more importantly, understand what this ISO means to the QMS and the wider organisation. Engage a consultancy firm to find out how a gap analysis and training on specific areas of ISO 9001:2015 can be of benefit to your organisation.
Finally, ask MRM to support you in formalising a transition plan and process and ensure that top management is involved from the start.
Summary
Remember that the ISO 9001
- is important for any standard
- does have a significant amount of changes through the incorporation of Annex SL’s core text and high level structure.
Training QP - Person Responsible for Regulatory Compliance
Written by QNET GroupQualified Person training Program
MRM has a program of education for today's quality and regulatory affairs professional. If you want to improve your competence, enroll in our flexible quality and regulatory modules:
- Module 1 - EU Regulatroy Frameworks
- Module 2 - EU Medical Device Design and Risk Management
- Module 3 - Clinical Evaluation for Medical Devices
- Module 4 - Developing and Maintaining Technical Documentation
- Module 5 - Quality Management Systems for Medical Devices
- Module 6 - Post-Market Surveillance and Vigilance for Medical Devices
- Module 7 - Working with EU Regulatory Stakeholders as Part of the EU Conformity Assessment Process
Who Should Enroll?
- Industry professionals representing product developers, manufacturers, distributors, service providers, entrepreneurs, investors and regulators dealing with medical device products,
- Whose work responsibilities include the preparation and management of medical device pre- and post marketing submissions to Competent Authorities
- Who prepare regulatory submissions to Competent Authorities and or Notified Bodies
- Engineering or life sciences graduates in the early stages of their regulatory careers.
- Professionals working for regulatory agencies
Please contact This email address is being protected from spambots. You need JavaScript enabled to view it. for more information.
The MDR proposal will make Post-Market Clinical Follow-up (PMCF) mandatory as part of the clinical evaluation cycle for the device concerned, essentially implementing the PMCF MEDDEV 2.12/2 Rev2.
This is a further degree of harmonization because at the moment there are different approaches implemented in EU Member states.
PMCF is defined as a continuous process to update the clinical evaluation. It is repeatedly stated that this shall be part of the manufacturers’ post-market surveillance plan.
The manufacturer must analyze the findings of the PMCF and document the results in a PMCF - Evaluation Report that will be part of the technical documentation. It has now been proposed to amend this requirement such that this report should be sent periodically to the concerned Member States.
For class III devices and implantables this report shall be further reviewed by a third party or external expert under the principles of highest scientific competence and impartiality.
PMCF implies that the requirements for clinical evidence increases substantially and will require an significantly higher investment from medical device manufactures in employing staff who are knowledgeable in (a) regulatory affairs, (b) Good Clinical Practice (GCP) and (c) clinical investigation design in order to work with and interpret clinical studies. By hiring or employing a person responsible for regulatory compliance this QP is able to communicate with Competent Authorities and Notified Bodies.
Post Market (Clinical) Surveillance / Follow-Up
- Post-market follow-up, ... is a continuous process ... and shall be part of the manufacturer's post-market surveillance plan.
- To this end, the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device, which is authorized to bear the CE marking, within its intended purpose ... with the aim of confirming the safety and performance throughout the expected lifetime of the device, the continued acceptability of identified risks and to detect emerging risks on the basis of factual evidence.
MDR - Post Market Clinical Follow-Up
- '... PMCF shall be performed pursuant to documented method laid down in PMCF plan ...'
- 'specify general methods and procedures, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of clinical data ...'
- 'The notified body shall periodically, at least once every 12 months, carry out appropriate audits and assessments to make sure that the manufacturer applies the approved quality management system and the post-market surveillance plan.'
Elements of Post Market (Clinical) Surveillance / Follow-Up => Post Market Surveillance Plan - Content
- The plan shall define the source of data and the means to collect those data and shall be proportional to the risk of device/device family.
- The plan may include:
- Complaints Handling;
- Return Products Analysis
- Vigilance Reports
- Literature Review
- Registry Review
- PMCF
- Regulatory Feedback
If you would like to maximize your QP / AR services, please contact us via This email address is being protected from spambots. You need JavaScript enabled to view it..