The MHRA previously confirmed that it would use expertise and decision-making from comparable regulator countries (CRC), (CRC countries are the EU, US, Australia, and Canada), to bring medical devices to the UK market. Within the system of recognition and trust, the so-called Reliance Route for Market Authorization (MA) framework, the MHRA retains the right to reject applications if necessary.

The new regulatory UK framework will enable faster market access in the UK for medical devices already approved by the CRCs. This MA framework also applies to medical devices with an MDSAP (Medical Device Single Audit Program) certificate. A potential issue is how to integrate 510K approved devices, as there is a degree of trust dependency on issued declarations of conformity.

Post-market surveillance (PMS) for medical devices remains a vital building block anchored in the new UK Regulations expected to be published in mid-November-December 2024. Implementing a “PMS Safety Net”, as part of the UK Regulatory Framework will be a priority. An important assumption is that medical device safety will be improved by the legal obligation for healthcare providers to report device issues.

The focus of the MHRA on PMS differs from that of the EU because the UK has the ambition to become an incubator of global innovation. The MHRA will continue to review the PMS requirements for CRC-approved devices and those with MDSAP approval under its regulatory reliance plan to ensure they remain fit for purpose and maintain safety.

As said, post-market surveillance (PMS) is critical to the UK’s medical device regulatory framework. Manufacturers must

• prioritize establishing a comprehensive PMS system,
• developing clear and organized PMS plans, and
• promptly reporting incidents and corrective actions.

Adhering to these regulations ensures their medical devices’ ongoing safety and reliability throughout their lifecycle, contributing to a safer healthcare system for patients and healthcare professionals. These regulatory changes aim to strengthen oversight for medical devices and in-vitro diagnostic devices in the UK, emphasizing improved post-market surveillance and vigilance to safeguard public health and enhance patient safety.

Some differences in the PMS between the EU and the UK are:

• The EU emphasizes the pre-market phase more than the post-market phase. UK Regulations emphasize the post-market phase.
• The UK regulation will use a broader definition for “preventive action”. “Potential failures” would be included within the definitions of “incident” and “serious incident”, implying serious deterioration of health classifications, such as
  • “hospitalization/prolongation”,
  • “medical treatment”,
  • “chronic illness”, and
  • “fetal distress/death”.
• The UK regulation requirements are different for:
  • investigating and reporting serious incidents;
  • preparing post-market surveillance reports, field safety corrective actions, and field safety notices;
  • trend reporting; and
  • retaining PMS documentation.

Highlights for Medical Device PMS

1. Clarified PMS Period: 

The PMS period starts from the day the first device of a model is put into service or placed on the market and ends with the last device’s end of life for that model. During this period, manufacturers must fulfill all PMS obligations, including creating a comprehensive PMS plan and submitting PSURs (Periodic Safety Update Reports) based on risk class.

2. MORE Portal Enhancements: 

The MHRA is enhancing the MORE portal, which is dedicated to adverse incidents and vigilance reporting, to ensure better user experience and reporting efficiency.

3. Post-Market Surveillance System: 

The UK mandates establishing a PMS system for each medical device proportionate to its associated risks. The system should continuously analyze quality, performance, and safety data throughout the device’s lifespan.

4. Post-Market Surveillance Plan: 

The PMS plan forms the basis of the PMS system and must be clear, organized, and searchable. It outlines processes for data collection, analysis, and interactions with relevant parties.

5. Preventive and Corrective Actions: 

Manufacturers must immediately reduce risks or non-conformities that compromise a device’s safety or performance. Notifications about field safety corrective actions are required.

6. Reporting Serious Incidents: 

Manufacturers must promptly report serious incidents involving their devices to the Secretary of State, including detailed information about the incident and any preventive or corrective actions.

7. Field Safety Corrective Actions and Notices: 

Manufacturers must conduct a risk assessment and notify the Secretary of State before implementing any field safety corrective actions. A Field Safety Notice must accompany the action.

8. Post-Market Surveillance and Periodic Safety Reports: 

Manufacturers are required to produce Post-Market Surveillance Reports (PMSRs) or Periodic Safety Update Reports (PSURs) for certain devices, summarizing surveillance data and actions taken.

9. Trend Reporting: 

Significant increases in the frequency or severity of incidents must be reported to the Secretary of State to investigate potential safety issues.

IDAP

The Innovative Devices Access Pathway (IDAP) pilot is an initiative to bring new medical technologies to the UK to help with medical needs that are currently unmet.

IDAP aims to enable and improve patient access to innovative and transformative medical devices by providing developers with an integrated and enhanced regulatory and access pathway.

Contact This email address is being protected from spambots. You need JavaScript enabled to view it. for more information.

See more details:

• https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1166483/Infographic_-_Devices_transition_timeline.pdf 
• https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/implementation-of-the-future-regulations#post-marketsurveillance-requirements
• https://www.youtube.com/watch?v=KjwOfdj14jo&t=36s (MHRA MedTech Regulatory Reform Webinar - March 5, 2024)
• https://www.gov.uk/government/publications/the-innovative-devices-access-pathway-idap/the-innovative-devices-access-pathway-idap-pilot-phase
• https://assets.publishing.service.gov.uk/media/63dbe1f68fa8f57fbfff3db3/medical-technology-strategy.pdf
• https://www.gov.uk/government/publications/international-recognition-procedure

Regulation (EU) 2024/1860 was published on June 9, 2024, in the Official Journal of the European Union (OJEU) with immediate effect. The amending Regulation provides extra time to conduct the conformity assessment of IVD’s needed for a CE certificate or an issued DoC.

This Amending Regulation extends the IVDR transition timelines while also recognizing as valid previously issued IVDD Certificates for the duration of those longer transition timelines. This allows manufacturers to continue placing their devices on the market based on compliance with the Directive and IVDR Art 110 provisions while transitioning them to the IVDR.

However, it is important to note that the extended transition timelines apply only to devices transitioning to the IVDR and meet additional specific conditions in the Regulation. These conditions ensure the manufacturer has taken appropriate steps to transition to the IVDR.

The table below shows the new transition timelines that apply for different IVD classes subject to the following conditions:

• Compliance with Directive 98/79/EC (IVDD) and no unacceptable risk to the health or safety of patients, users, or other persons, or other aspects of public health protection.
• No significant changes were implemented in the design or intended purpose of the device.
• No later than 26 May 2025, the manufacturer has placed an IVDR-compliant QMS.
• No later than the applicable deadlines below, the manufacturer has lodged an IVDR application and has signed a formal written agreement with a Notified Body.

*Conditional to certificates validity (Art 110(2)).

IVD devices covered by IVDD Certificates that were valid as of 26 May 2022, but expired before the publication of this new amending Regulation (dated July 9, 2024) benefit from the extended transition timelines (as shown in the table above) if the manufacturer

• Has applied to an NB and has a signed agreement with an NB before the expiry of the IVDD Certificate, and/or
• Has a granted derogation/exemption issued by a Competent Authority under either Article 54 or Article 92 of the IVDR.

We recommended that manufacturers who have already made or planned their IVDR applications and documentation submissions with an NB do not deviate from their plans.

We strongly recommend manufacturers who are yet to make their IVDR applications to submit them as soon as possible for the following reasons:

• Only those devices transitioning to the IVDR benefit from the longer transition timelines and extended validity of the Directive Certificates for those devices.
• Delaying or changing your current planned submissions will mean that the submissions will be added to the end of the review queue. This has a potential risk of a delayed conformity assessment by an NB.
• Manufacturers cannot change their devices' design or intended purpose under the Directive, even under the longer transition timelines.

Class D IVDs, following the designation of European Reference Labs (EURLs): NB adopted a risk-based Class D transition strategy whereby they actively engage in conformity assessment of high-risk (Class D) devices. Per October 1, 2024, when the designated EURLs are actively operating, NB’s will transition Class D devices into the new framework. The aim is a consistent approach for performance verifications and batch tests on Class D devices.

Contact This email address is being protected from spambots. You need JavaScript enabled to view it. for more information.

The UK medical device regulatory system is independent of the European Economic Area (EEA). All medical device manufacturers will need to follow UK laws for (in vitro) medical devices, based on the EU regulations EU-MDR 2017/745 and EU-IVDR 2017/746. All non-UK manufacturers must have a UK-based UK Responsible Person (UKRP) designated and registered at the MHRA, and take the responsibility for the product in the UK.

The UKRP is the equivalent of an EU Authorised Representative.

UK-based manufacturers need to appoint an EU Authorized Representative. UK comprises England, Scotland, and Wales. Northern Ireland is part of the UK, but will essentially remain within the EU Customs Union, so manufacturers will still comply with European rules and affix the CE mark.

Registration MHRA

All medical devices (including in-vitro diagnostic medical devices) placed on the UK market will need to be registered with the MHRA (UK). 

The registration deadlines are as follows:  

• Class III, Class IIB implantables, all active implantable medical devices, and IVD List A products must be registered before May 1, 2021.
• Other Class IIB, all Class IIA devices, IVD List B products, and Self-Test IVDs must be registered before September 1, 2021.
• Class I devices, custom-made medical devices (CMMD), and general IVDs (that do not currently need to be registered) must be registered before January 1, 2022.

UKCA mark

CE marked medical devices will continue to be recognized in the UK until June 30, 2023. After that date only the new UKCA symbol will apply. CE-certificates issued by EU designated Notified Bodies will continue to be valid for the UK market until June 30, 2023, unless the certificate expires before this date. The UKCA mark will not be recognized in the EU, EEA, or Northern Ireland markets, and products currently requiring a CE mark will continue to have a CE mark for these three markets. Manufacturers will be able to use the UKCA mark voluntarily in the period until June 30, 2023.

UKRP responsibilities

The UKRP will act on behalf of the manufacturer to carry out specified tasks in relation to the manufacturer’s legal obligations. This includes registering the manufacturer’s devices with the MHRA before the devices can be placed on the UK market.

A UKRP is responsible for:

• ensuring that the manufacturer
  • the device declaration of conformity (DoC) complies with the requirements;
  • the technical documentation complies with the requirements;
  • has an appropriate conformity assessment procedure.
• keeping available for the MHRA
  • a copy of the technical documentation,
  • a copy of the declaration of conformity, and
  • a copy of the relevant certificate(s), including any amendments and supplements.
• responding to a request from the MHRA.
• providing the MHRA with all the information and documentation necessary to demonstrate a device's conformity.
• that the manufacturer providing samples or allow access to the device to the MHRA when requested.
• cooperating with the MHRA on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices.
• immediately informing the manufacturer about complaints and reports from healthcare professionals, patients, and users about suspected incidents related to a device for which they have been designated.
• terminating the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under the applicable Regulations and informing the MHRA and, if applicable, the relevant ‘UK-Approved Body’ that termination.

If the manufacturer uses a UK importer that is not the UK Responsible Person, the importer will be required to inform the relevant UKRP of their intention to import a device.  In this case, the UKRP will be required to provide the MHRA with a list of device importers.  Existing obligations around storage, transportation, and checking device labels for the CE marking or UKCA marking will continue to apply.  The importer’s name and address will not need to be present on the label unless the importer or distributor is acting as the UKRP.

The period between January 1, 2021, until June 30, 2023:

• CE-certificates issued by EU-recognised Notified Bodies will continue to be valid for the UK market. After June 30, 2023, the EU will no longer recognize UK Notified Bodies.
• UK Notified Bodies will not be able to issue CE certificates (other than for the “CE UKNI” marking, which will be valid in Northern Ireland) and become ‘UK Approved Bodies’.
• A new route to market and product marking is available for manufacturers wishing to place a medical device on the UK market.
• All medical devices, including in vitro diagnostic medical devices (IVDs), placed on the UK market will need to be registered with the MHRA. There will be a grace period for registering.
• CE mark with a UK Conformity Assessment (UKCA-mark) is voluntary, and when the UKCA mark is in use, the labeling also needs to comply.
• The name and address of the UK Responsible Person will need to be included on product labeling where the UKCA mark has been affixed.  

Note. UK Responsible Person details will not need to be included on labeling for CE marked devices.

After June 30, 2023

• All product labeling needs to comply with the UK medical device regulations, including UKCA logo.
• The UK will allow self-certification for medical devices that are Class I self-certified or general IVDs (companies can attach the UKCA mark once compliant with the UK legislation).  Higher-risk medical devices and IVDs will require approval from a UK Approved Body, who will issue a UKCA certificate. The UKCA mark can then be added to the labeling.  
• Existing UK Notified Bodies with designations under the MDD, IVDD, or AIMDD will automatically become UK Approved Bodies.  However, EU-based Notified Bodies will not be able to issue UKCA certificates.
• The UKCA mark will become mandatory for devices intended for the market in the UK. 

Northern Ireland

Northern Ireland will have different rules from UK. The following requirements will apply to manufacturers wishing to place medical devices on the Northern Ireland market:

• The EU MDR and EU IVDR will apply in Northern Ireland from May 26, 2021, and May 26, 2022, respectively.
• The CE marking will continue to be required.  In addition, the UKNI marking will be required if a UK Notified Body undertakes mandatory third-party conformity assessment.
• After the transition period, certain medical devices, including in vitro diagnostic medical devices (IVDs), placed on the Northern Ireland market will need to be registered with the MHRA.  Class I devices and general IVDs placed on the market by Northern Ireland manufacturers and Authorised Representatives based in Northern Ireland must be registered. For other device risk classes, there will be a grace period for registering.
• When placing devices on the Northern Ireland market, UK-based manufacturers will need to appoint an EU Authorised Representative.

Access Consortium (ACSS)

The MHRA has joined the Australia-Canada-Singapore-Switzerland (ACSS) Consortium (now known as the Access Consortium). Companies that submit applications to some or all of the five Access countries may benefit from having their products evaluated for marketing in those countries simultaneously with reduced evaluation times. The Access Consortium will update the guidance for industry on how to apply to have products considered for marketing authorization across the five-member countries, including the UK.

Find out more

QNET Ltd. can provide UKRP services if your devices are placed on the UK market. To discuss your business needs in more detail, please contact QNET Ltd. This email address is being protected from spambots. You need JavaScript enabled to view it..

Depending upon client company needs, we offer the following services:

• We assist companies in understanding and complying with European and UK medical device requirements, including data entry into Eudamed and the MHRA register
• As UKRP service provider we support manufacturers in registering their medical devices into the MHRA register.
• We contacting designated notified bodies and or UK Approved Bodies to carry out activities related to the CE or UKCA marking process.
• We provide serving as the official contact with European and UK authorities.
• If a medical device is intended for clinical investigations, notifying applicable national competent authorities.

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.

1. 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

2. 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. 

The EU Commission issued a 7 page notice on January 10, 2018 titled: ‘Withdrawal of the United Kingdom and EU Rules in the field of industrial products’

This notice clarifies that after March 30th 2019 the UK becomes a Third Country (NON-EU Country).

The consequences affecting non-EU manufacturers are:

1. UK office based Authorized Representatives service providers will no longer be recognized in the EU. [MRM is not affected because we are office based in The Netherlands.]  
2. UK Notified Bodies will lose their status as EU Notified Bodies and will be removed from the EU System (NANDO). UK Notified Bodies will no longer be able to perform assessments and any certificates they issued will need to be replaced by a non-UK Notified Body.

Products affected by this include the following:

-                      Medical Devices

-                      Active implantable devices

-                      In-Vitro Diagnostic medical devices

-                      Personal Protective equipment

-                      Machinery

-                      Pressure Equipment

-                      ATEX Equipment

and many others. 

Actions to be taken: 

-                      Check if your UK Notified Body or test house has opened an office in another EU Member State.

-                      Check if your UK Authorized Representative has an alternative plan.

-                      If not: Contact our Dutch office for support.

Many manufacturers will be wondering if this is a BREXIT negotiation tactic by the European Commission? No doubt it is and the words ‘subject to any transitional arrangements’ do appear in this European Commission notice.

However the real question is: Do you want to stake your EU sales on these negotiations?

European Medical Device Regulations 2017/745 (MDR) and In Vitro Diagnostic Regulations 2017/746 (IVDR) are published May 5, 2017 in the Official Journal of the European Union (OJEU), May 4^th, 2017.

The MDR will replace the Active Implantable Medical Devices Directive (AIMD 90/385/EEC) and the Medical Devices Directive (MDD 93/42/EC), while the IVDR will replace the In-Vitro Diagnostic Medical Devices Directive (IVDD 89/79/EC).

Transition period

The official transition started by publication of both regulations in the Official Journal (May 4^th, 2017). This means that the implementation period officially begin on May 25^th, 2017. Manufacturers of medical devices will have maximum three years (until May 25^th, 2020) to comply with the Medical Device Regulations (MDR), whilst the in  vitro diagnostic device manufacturers will be given five-year transition period (until May 25^th, 2022).

Given numerous changes in the regulatory compliance process, especially for high-risk devices, manufacturers are strongly advised to start implementing new requirements as soon as possible in order to safeguard their EU compliance for their medical devices.

Important dates:

May 25^th, 2017: Official entry into force of MDR 2017/745 and IVDR 2017/746

March 25^th , 2020: Eudamed will go live

May 25, 2020: MDR date of application

May 25, 2022: IVDR date of application

May 25, 2024: AIMD, MDD and IVDD certificates become void.

Examples of Key Changes:

* Control of high-risk devices such as implants involve also panels of independent experts at EU level

* Clinical trials taking place in more than one Member State will be subject to a single coordinated assessment

* Many aesthetic products are regulated as medical devices and subject to stricter controls

* Four out of five in vitro diagnostic medical devices are checked by a Notified Body before they are placed on the market

* European database contains extensive information on medical devices, most of which is publicly available

* An "implant card" for implanted devices gives patients more information

* A financial mechanism ensures patients are compensated in case defective medical devices harm them

* Simplified procedure allows manufacturers to register their device only once at the EU level

(May 1, 2017)

The Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR) were initially proposed in 2008 when the EU Commission triggered a consultation on the community’s existing requirements covering medical devices. The plan was 1^st released by the commission in 2012 to modify the EU’s medical device regulatory framework along with a proposed regulation replacing the EU’s current Medical Device Directive 93/42/EC,the EU’s directive on Active Implantable Medical Device 90/385/EC, and the In Vitro Diagnostic Directive 98/79/EC.

Medical Device Regulation (MDR). This regulation aims to ensure the smooth functioning of the internal EU market in regard Medical Devices, taking as a base a high level of protection of health for patients and users. At the same time, this regulation sets high standards of Quality, Safety, and Performance for Medical Devices in order to meet common Safety concerns as regards such products.

In Vitro Diagnostics Regulation (IVDR). This regulation will avoid differences in national interpretation, and will also strengthen Patient Safety through the introduction of more stringent procedures for Conformity Assessment, Post-Market Surveillance and through requirements to generate Clinical Data providing Evidence on Safety, Performance and any Undesirable side-effects. This should also allow rapid and cost-efficient market access for Innovative Medical Devices.

The Main Proposed Changes in the Regulations: Wider, Clearer scope of the products covered

Medical Device Regulation (MDR):

The scope of the products will become broader to include Medical Devices which (a) may not have the intended medical purpose or (b) include devices for the purpose of prognosis of the a disease or any other health condition due to  the impact of the MDR on the scope of the products.

In Vitro Diagnostics Regulation (IVDR):

The scope of the IVDR matches the scope of the In Vitro Diagnostic Directive 98/79/EC has not significant changed, but changes can be found extended requirements on risk classification and mandatory conformity assessment of high-risk devices by accredited notified bodies. Assessment of the technical file will be focused on i.e. performances, clinical evidence of i.e. genetic testing devices, companion screening and diagnostic devices, and medical software.

Changes in the Clinical Investigation

In the Medical Device Regulation (MDR):

For class III and Implantable medical devices the MDR will put in place a European regimen for clinical investigations that will replace the diversity of member state regulations in the EU. It will introduce several concepts relating to clinical evaluation and clinical investigation, as well as a mandatory Post-Market Clinical Follow-up (PMCF) and Periodic Safety Update Reports (PSUR’s). This will require

-       a thorough design and review of the manufacturer’s Clinical Strategy and PMCF plans

-       to conduct clinical performance

-       providing evidence of Safety and Performance in accordance to the risk associated with the device and

-       to collect Post-Market Clinical Data.

With the MDR rules, the manufacturer will need to perform a gap analysis to identify gaps in Clinical Evidence to be in compliance of MEDDEV 2.7.1 rev.4.

In the In Vitro Diagnostics Regulation (IVDR):

It will be necessary to collect clinical evidence for all IVD devices. Clinical evidence is defined as clinical data and Performance Evaluation results pertaining to the device of sufficient amount and quality to allow a qualified assessment of whether the device achieves the intended Clinical Benefit(s) and Safety, when used as intended by the manufacturer.

Unique device identification (UDI)

In the Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR):

In order to improve the ability of the authorities and manufacturers to trace the specific devices through the supply chain and to smooth the recall process of Medical Devices that have been found to present a safety risk, the proposed Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) mandates the use of Unique Device Identification (UDI) mechanisms.

Provisions regarding registration of devices and economic operators, in particular those governing the Unique Device Identification system have been complemented and clarified. They should lead to the establishment of a more functional system related to Identification and Traceability of devices, while maintaining alignment with international principles and practices in this field.

Classification and Conformity Assessment

In the Medical Device Regulation (MDR):

There will be an impact on the classification for certain medical devices; reclassification of the medical devices to a higher risk class is possible such as for some reusable surgical instruments. However, the MDR reclassification is mainly impacting class II implants (class III if they come into contact with the spinal column (rule 8)) and substance-based medical devices.

The review of the lower risk devices will be highly enforced on Clinical Evaluation so the manufacturer should revisit the content of the current Technical Documentation as there will be an impact on the existing Quality Systems and to take into account the changes in the conformity assessment rules, the Regulation will feature new essential Safety and Performance requirements for example.

In the In Vitro Diagnostics Regulation (IVDR):

The classification system of the regulation has been adapted to correspond to the rapid increase in scientific, medical and technical knowledge and to the resulting development of more advanced devices. The regulation introduces new risk-based classification rules for IVD devices and is therefore less arbitrary that the current classifications in the IVD Directive. This will allow room for changes and emerging technology. For example, infectious disease, cancer screening and congenital screening will now fall under Class C devices. These devices will require input from the Notified Body, whereas in the past many of these products were self-declared by the manufacturer. In addition, the provisions on Conformity Assessment have been clarified but continue to be based on the existing well-established system. However those provisions on assessment of high-risk devices have been considerably strengthened with a view to patient safety. Requirements have also been included for Competent Authority (CA) consultation in the case of Companion Diagnostics.

Impact on the Post Market Activities

In the Medical Device Regulation (MDR):

The major change in this process is mainly driven by the request of real-life data for the Post-Market Clinical Performance Evaluation (PMCF). Its results must be taken into account for Clinical Evaluation and Risk Management update.

The manufacturer will need to review their current Post-Market Surveillance (PMS) and Vigilance procedures with evaluation linked to the review of the Risk Management and Clinical Evaluation. The National Competent Authority of the Notified Body will be increased with emphasis on Unannounced Audits, along with product sample checks and product testing. Annual Safety and Performance reporting by device manufacturers will also be required in many cases.

In the In Vitro Diagnostics Regulation (IVDR):

Although Vigilance and Post-Market Surveillance (PMS) have always been a requirement, there are more prescriptive measures laid out in the new Regulation which includes specific direction on the use of data gathered by the manufacturer's Post-Market Surveillance system. In addition there will be new documentation requirements such as Periodic Safety Update Reports (PSURs) with additional requirements based on the device classification.

Identification of Qualified Person (QP)

At least one person must be assigned within the organization that should be responsible for all aspects of compliance with the requirements of the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). The qualifications of this individual must be documented and be available upon request. The qualifications of this person can be demonstrated by evidence of formal qualification awarded on the completion of a university degree or of a course of study recognized as equivalent by the Member State concerned. The Qualified Person must also have at least one year of professional experience in Regulatory Affairs or in Quality Management Systems (i.e. ISO 13485).

Expected timeline for the changes and how you as  manufacturer can prepare

The timeline for the changes is dependent upon the final publication (probably May-June 2017). As independent professional and recognized quality and regulatory service provider we’re qualified and able to support you in your efforts to be in full compliance with the MDR and or IVDR requirements.

We’re looking forward to provide you guidance in the challenges you are facing as individual company what you may use as proactive evidence to present to your notified body during coming scheduled audit.

Many European and IMDRF documents refer to ISO 14155 as a ‘conformity’  standard. So it is an important tool to demonstrate compliance with the EU regulatory requirements.

Especially when performing clinical evaluation to demonstrate and provide clinical evidence what is needed and required to support defined medical claim of the medical device under CE marking. Requirement in the EU Medical Device Regulations (MDR).

By doing a GAP analysis and assessment of your technical file (DHF, DMF), it is not always possible to strictly align the applicable MDR wordings in the medical device investigation plan.

The requirements in the ISO 14155 provide in-depth guidance on the methodology to conduct clinical investigations. Although these requirements do not refer to specific national nor regional strict regulatory requirements, ISO 14155 is an excellent useful document ‘tool’ as guidance for clinical investigation and clinical evaluation with medical devices.

Other relevant requirements or guidance’s are:

-          Declaration of Helsinki

-          ICH Guidance

-          Good Clinical Practice (GCP) for clinical trials

The MDR provide also a more in-depth focusing on the quality assurance aspects of the investigational medical device itself. The MDR aligns important elements of the ISO 13485, and the FDA QSR, such as

-          The medical device is ready for human use, including any updates of the investigation brochure contents and when design changes may occur during a clinical investigation;

-          Sufficient information is provided to assure safe use of the investigational devices, with greater emphasis on user training;

-          Device malfunction reporting is accurate; and

-          Safe disposition of unused devices.

The ISO 14155 standard states its scope includes both pre- and post-market clinical investigations, while explaining that if the sponsor wishes to deviate from its requirements, a justification must be given.

This raises several questions including; ‘ What elements of the ISO 14155 standard are voluntary and when?’; ‘What type of clinical investigations are we talking about?’

To answer these questions it is important to define:

(A) the different phases of clinical investigations:

-          Pilot

-          Pivotal

-          Post-market

 (B) the design of the investigation plan:

-          Exploratory

-          Confirmatory

-          Observational

(C ) examples of earlier studies in each phase

(D) motivation of the statistical considerations in the investigational plan;

(E) Risk Management considerations (i.e. ISO 14971)

(F) Ethical considerations.

As professional EU Authorized Representative service provider we’re looking forward to support you in your efforts to be in compliance with the EU regulatory requirements (MDR)! Please contact us for support and or for required clinical expertise.