Bionuclear Science is also a Graduate Member of IET (UK Institution of Engineering and Technology), as well as The Institution of Engineers Australia, Biomedical Division.

Welcome to Consult Medical Ltd

EU Authorised Representative, Regulatory & Quality Consultants for Medical Devices

EU Authorised Representative Service
(EUAR / EC Rep / EU Rep)
Medical Devices: MDR (EU) 2017/745
In-Vitro Device Regulations: IVDR (EU) 2017/746

The appointment of an EU Authorised Representative (EC REP) is a mandatory appointment for medical device manufacturers located outside the EU who wish to sell and place on the medical and in-vitro devices market in the EU.
Consult Medical’s EU Authorised Representative Service goes well beyond the obligations of European Medical Device Directives and associated EU guidelines, and also the Medical Device Regulations, to provide professional advice and vital regulatory news updates.
Therefore, if you are a manufacturer of Legacy Devices or fully compliant MDR / IVDR devices, we have a service that meets your needs.
As required by the EU Regulations, Consult Medical employ qualified individuals who possess the necessary expert knowledge on regulatory requirements for medical devices. This knowledge is supported by academic qualifications and professional experience in regulatory affairs and quality management relating to medical devices.
Our service has been developed over many years to specifically support the needs of small and medium-sized manufacturers.

Consult Medical work in close partnership with our clients to improve the health and safety of patients, our team is committed to quality and excellence in everything we do to support clients throughout the full product lifecycle. We provide an invaluable means of keeping up-to-date with the ever-changing regulations and standards.

We provide a presence across 6 Continents and provide critical support services to global pharmaceutical, biotechnology and medical device clients across 6 continents.
We have offices in 3 countries and a growing team of professionals providing the highest quality of services on a global scale supported by regional expertise. 

Contact Us
For more information, please contact the Consult Medical team:

Calle Manolo Millares, 65
Arricefe
35500
Las Palmas
Spain
Telephone:  0034 92812 1837
Email: admin@grupobytcanarias.com

---------------------------------------------------------------------

Nieuwe Emmasingel 89
5611 AM Eindhoven.
The Netherlands
Telephone: 0044 750 2537 47

Mansion House
Manchester Road
Altrincham
Cheshire
WA14 4RW
United Kingdom
Telephone: 0044 750 2537 47 

EU Medical Device Regulatory Consultancy Services
Consult Medical provides expertise for all aspects of the medical device regulatory approval cycle. Our all-inclusive regulatory support includes assistance with EU Technical Files and a professional EU Authorised Representative service.

Consult Medical has an in-house team of experienced and professional consultants capable of helping you with all elements of regulatory compliance required to bring your products to market. We provide a comprehensive range of consultancy services, including: 

  • EU Technical Documentation Creation and Compilation. 
  • Technical Documentation Review and Gap Analysis. 
  • ISO 13485 QMS Setup / Internal Audit.
  • Bespoke Training Services. 
  • Label and IFU Guidance. 
  • General EU Consultancy. 
  • Retained Quality / Regulatory Consultant

As specialists in simplifying regulatory compliance for start-ups and small to medium-sized enterprises, our consultancy services are tailored to your needs at competitive cost-effective rates.
Our team of consultants maintain and improve their skills and knowledge through ongoing training and attendance of key seminars to ensure we continue to remain at the forefront of regulatory knowledge. Furthermore, our significant experience in guiding clients through Notified / Regulatory Body audits ensure we know what such authorities are expecting from the required documentation content.
Consult Medical is certified by the ‘Agencia Espanola de Medicamentos y Productos Sanitatios’ for conformity to ISO 13485 for European Authorised Representative service, quality management, regulatory affairs and document creation and control for medical device manufacturers.
Consult Medical will continue to lead by being a prominent English speaking international medical device consultancy based in both the Netherlands and Las Palmas, Spain for EU registrations. 

Quality Management Consultancy for Medical Devices

Our experts will help you to create and operate an efficient quality management system that minimises overheads and complexity and complies with ISO 13485 as well as the requirements of Article 10 of the EU MDR and IVDR.
We can help with the preparation, installation and auditing of electronic or paper quality management systems to: 

  • ISO 13485
  • MDSAP
  • MDR/IVDR Article 10
  • ISO 10993
  • ISO 14155

Why is Quality Management important?


The need for some form of a Quality Management System (QMS) has been a long-term requirement for Medical Device manufacturers.

Under the old regulations a certified Quality Management System was not specifically required for lower risk Medical Devices but manufacturers have always been obliged to have a manufacturing control function, and related procedures and records, particularly in respect of document control, traceability, vigilance and complaint reporting, and validation necessities.
Now the international standard ISO 13485 has become the gold standard for companies to work to and conformity to EN ISO 13485:2016 which has become expected and, particularly for higher class Medical Devices, to be separately certified by their Notified Body.
Class I medical device manufacturers and Class A IVD manufacturers should keep in mind that while a QMS is a mandatory requirement in accordance with Article 10 of both EU Regulations, a certificated QMS (e.g. audited by an accredited body) is not mandatory.
This Quality Management System standard describes the way a company should incorporate common sense control of their design processes, manufacturing, packaging, sterilisation and finish processing, and dispatch to the end user. In addition the standard discusses the need for post market activities through to the end the end of life of a medical device – Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF), so much that it is now considered as essential.
Under the new European Medical Device regulations, and In-Vitro Diagnostic Medical Device regulations, ISO 13485 is an important adjunct to demonstrate that company has control to meet its legal route and regulatory responsibilities, and in particular the need to comply to product liability requirements.
Consult Medical specialise in the creation, of Medical Device Quality Management Systems for all manufacturing and related services. 

ISO 13485: 2016 Consultancy


For all medical device manufacturers marketing and selling their products within the EU, the controls for the product lifecycle must be found within a documented quality management system. For all class IIa, IIb and III devices produced under a full quality assurance system must be in accordance to ISO 13485, the current state of the art in medical device quality management system standards.

ISO 13485 is not only a quality system standard but one for which the whole organisation is required to engage, touching upon almost every aspect of the business operation. For all those wishing to comply with the standard getting started and understanding the best way of making the standard work for you can be daunting.
The general requirements for compliance to the standard include many different procedures and record types in order to be certified, all of which must be reviewed, approved, maintained and updated to remain in compliance.
Here at Consult Medical we can help build these processes and documents whether starting from scratch or if requiring an upgrade to meet your organisational needs and objectives.
The benefits of the implementation include: 

  • Increased access to worldwide markets
  • Increased organisational efficiency.
  • Increased competence and industry awareness.
  • Adopt a systematic approach to meeting the regulations as well as customer expectations.

Tailoring the system to your needs allows additional efficiency, quality and reliability for your product and for your company.
Consult Medical specialise in the creation of medical device quality management systems for all manufacturing and related services to assist in you becoming compliant to the ISO 13485 standard. 

QMS Gap Analysis and QMS Services

A Quality Management System (QMS) is the backbone of the design, production, and management of medical devices. It is now mandatory for all medical device manufacturers to have a quality management system (QMS) in compliance with Article 10 of the MDR/IVDR.

Article 10 of both the EU Medical Device Regulation 2017/745 (MDR) and the EU In Vitro Diagnostics Regulation 2017/746 (IVDR) require that all manufacturers set up and use a Quality Management System. Article 10 provides the minimum requirements which should be met by such a QMS; some of which are not indicated within ISO 13485:2016.
Consult Medical offers a variety of services related to the creation, maintenance, and upgrade of QMS, including:  

  • ISO 13485:2016 compliant QMS, gap analysis, or upgrade. 
  • MDR/IVDR QMS requirements gap analysis or upgrade
  • MDSAP gap analysis or upgrade. 
  • Internal audit services. 

Consult Medical specialises in the creation medical device quality management systems for all manufacturing and related services to assist you in becoming compliant to the ISO 13485: 2016 standard. Following an initial conference call, we will be able to put together the backbone documentation and processes required for a compliant ISO 13485:2016 QMS. If you already have a compliant QMS, we can suggest how to incorporate requirements of the EU Regulations or MDSAP into your existing procedures.
For those manufacturers of low-risk devices looking to only specifically meet the requirements as listed in Article 10 of the EU Regulations, we also offer a lighter QMS solution. You would then be expected to build on this and develop the appropriate records as you use the QMS.
Manufacturers may also wish to ‘stress test’ their QMS in preparation for an upcoming audit. We can conduct a Documentation Gap Analysis to highlight nonconformities with respect to the standard, or we could perform a more in-depth Internal Audit to test your processes. The Consult Medical gap analysis will evaluate your QMS and assess your level of compliance, identifying any opportunities for improvement, observations or nonconformities when comparing your current QMS to the standard. After completion of the gap analysis we will provide a full written report which you can use as a guide to upgrade your QMS internally, or alternatively Consult Medical can upgrade your QMS for an agreed fee.  

MDSAP 

If it’s your intention to access US, Brazilian, Japanese, Australian and/or Canadian markets you will be required to comply with the requirements of the Medical Device Single Audit Program (MDSAP).
The MDSAP program involves a recognised certification body conducting a single regulatory and quality audit of a medical device manufacturer which aims to satisfy that all the relevant requirements for the participating regulatory authorities have been implemented.
At Consult Medical, we have experts who specialise in guiding manufacturers to compliance whether it’s ISO 13485:2016 or with the additional requirements of MDSAP and the first logical step is to perform a gap analysis.
The Consult Medical gap analysis will evaluate your QMS and assess your level of compliance, identifying any gaps, deficiencies or nonconformities when comparing to your current QMS to the standard you wish to achieve.
After completion of the gap analysis we will provide a full written report which you can use as a guide to upgrade your QMS internally, or alternatively Consult Medical can upgrade your QMS for an agreed fee.
This service is particularly helpful for SME’s and start-up organisations whose depth of resources may not allow for a gap analysis to be conducted internally.
For more information on how Consult Medical can assist with assessing your QMS to either ISO13485:2016 or to include the requirements of MDSAP certification or even to implement a new QMS, please contact the Consult Medical team. 

Technical Files Consultancy (EU Technical Files)

The need for a detailed Technical File, i.e. the complete technical documentation needed to demonstrate that a particular Medical Device, or In-Vitro Diagnostic Medical Device, conforms to the regulations and is safe to place on the market, is essential for all devices, even those that are for low-risk.

As part of their key obligations under the EU Regulations for medical devices and IVDs, manufacturers are required to draw up technical documentation in accordance with Annexes II and III of the EU Medical Device Regulation 2017/745 (MDR) and the EU IVD Regulation 2017/746 (IVDR), as applicable.
A technical file built in accordance with these Regulations will typically consist of the following: 

  • Device Description and Specification
  • Information provided by the Manufacturer (IFU, Labels, Marketing Material, Implant Card).
  • Design and Manufacturing Information.
  • General Safety and Performance Requirements.
  • Risk Management (ISO 14971), including:

                                   • Risk Management Plan.
                                   • Risk Identification and Assessment.
                                   • Risk Management Report. 

Verification and Validation, including:

  • Pre-clinical testing, including where relevant:

                                • Biological Evaluation Plan / Report (ISO 10993).
                                • Electrical and EMC Considerations (IEC 60601 Series).
                                • Software Validation (EN 62304).
                                • Usability (IEC 62366).
                                • Sterilisation Validation. 

  • Clinical Data: Clinical Evaluation Plan and Report (CEP/CER), or Performance Evaluation Plan and Report (PEP/PER) for the MDR and IVDR respectively.
  • Post-Market Surveillance (PMS), including:

                             • PMS Plan.
                             • PMS Report / Periodic Safety Update Report (PSUR).
                             • Post-Market Clinical Follow-up (PMCF) Plan and Report. 
• Declaration of Conformity.
• Summary of Safety and Clinical Performance (where applicable). 

This should NOT be considered a complete list of required documents, since the documentation required to demonstrate conformity with the applicable Regulation will greatly depend on the device and its intended purpose.
The extent of work involved and information available within the technical file will vary depending on the overall risk of the device, the device type, its intended purpose and indications, target patient / user populations, as well as its sterility, activity, invasiveness and whether it contains medicinal products, tissues, and CMR and endocrine-disrupting substances.
When compiling technical documentation, we take into account our extensive experience with Notified Body audits and expectations, as well as state of the art EU and International guidance, including applicable MEDDEV and MDCG Guidance, IMDRF, and US FDA-issued guidance to mention a few.
All of our consultancy projects will typically begin with a conference call to discuss the device and the activities involved. Depending on the information already available, we will then discuss the information and documentation which may be required to build the technical file.
Our team of consultants maintain and improve their skills and knowledge through ongoing training and attendance of key seminars to ensure we continue to remain at the forefront of regulatory knowledge. Furthermore, our significant experience in guiding clients through Notified audits ensure we know what such authorities are expecting from the required documentation content.
For more information, please contact the Consult Medical team. 

Clinical Evaluation

The Clinical Evaluation Report (CER) is a document which presents all the clinically relevant data collected for a particular device.

The Clinical Evaluation is a crucial element of a device’s conformity with the general safety and performance requirements (GSPR) of Annex I of the EU Medical Device Regulation 2017/745 (MDR), which should take into account the device’s normal conditions of its intended use and evaluate undesirable side-effects and the acceptability of the benefit-risk ratio (as referred to in Sections 1 and 8 of Annex I). In general, the basis and requirements for the Clinical Evaluation are laid down in Article 61 and Annex XIV of the MDR.
The Clinical Evaluation shall be planned in accordance with the requirements of Annex XIV Part A, and be recorded within a Clinical Evaluation Plan (CEP). Manufacturers should also have in place an updated Clinical Evaluation Procedure, as part of their Quality Management System (QMS), which shall provide an indication for the need of a CEP in order to comply with the MDR, as part of their technical documentation. The CEP shall take into account the intended purpose of the device, its indications and contraindications, description of the clinical benefit, and shall provide a Clinical Development Plan which outlines the progression from exploratory investigations to Post-Market Clinical Follow-up (PMCF).
Once these activities are performed, they shall be reported and analysed within the device’s Clinical Evaluation Report (CER), which is arguably the most important document within the technical documentation and which summarises and presents the clinical data collected to substantiate its claims of safety and performance against its claimed indications.
Even though some of the more simple and low-risk devices may not require clinical data to demonstrate conformity with the general safety and performance requirements (Article 61(10)) they must still have a Clinical Evaluation Plan and Report in place. The complexity of these documents will vary greatly depending on device risk, device type, and novelty. For higher risk devices, one would expect a greater collection and analysis of relevant clinical data, preferably obtained through clinical investigations.
Nevertheless, the CER will be expected to have a fixed structure. The MEDDEV 2.7/1 rev.4 guidance, released in 2016 for use in collaboration with the MDD, is still considered relevant and the state of the art with respect to laying out the overall format of the Plan and Report. Therefore, the backbone of each CER would not be expected to differ too much.
Although the requirements to draw up a CER have not changed significantly moving from the EU Medical Device Directive 93/42/EEC (MDD) to the MDR, there are higher expectations with respect to the quality of the content demonstrating the clinical safety and performance of the device. It is important that all claimed indications are backed up by sufficient clinical data and a robust PMCF Plan. Something to keep in mind is that the path down the Equivalence route has become more challenging under the MDR; unless you are the manufacturer of the predicate or draw up a contract with the manufacturer of the equivalent device to have access to their documentation, claiming equivalence may no longer be a viable option.
An understanding of Article 61, Annex XIV, as well as relevant MEDDEV and MDCG guidance documents will be paramount in meeting the requirements of the Clinical Evaluation and thus getting your product to market.
Consult Medical specialises in the creation of Clinical Evaluation Plans and Reports for all device types, utilising our team of in-house and experienced consultants. The documents we create for you are state-of-the-art and are continuously being updated to reflect changes in interpretation, best-practice, and Notified Body expectations. Furthermore, you may wish to contract Consult Medical to review your Clinical Evaluation prior to submission to a NB. Our review will highlight any deficiencies and also provide guidance in closing these gaps, all within one report.
For more information, please contact the Consult Medical team. 

PMCF

Post-Market Clinical Follow-up is steadily becoming a main element of conformity with the EU MDR

Post-Market Clinical Follow-up (PMCF) is not an entirely new concept. It was originally introduced in the EU Medical Device Directive 93/42/EEC (MDD) with guidance on this requirement provided through MEDDEV 2.12/2 rev.2. The EU MDR builds on this concept further, with PMCF being mentioned over 50 times within the Regulation. In fact, PMCF has become one of the most essential sections of a compliant technical file, showing the organisation’s willingness and commitment to obtaining high-quality clinical data to continually assess a device’s safety and performance within the post-market stage.
A PMCF Plan should be drafted up for each medical device within a manufacturer’s organisation; the terminology used within the MDR leaves very little wiggle room for manufacturers to avoid conducting any sort of PMCF.
The MDR splits PMCF activities into either General or Specific Methods, with General Methods involving activities such as collecting post-market feedback (e.g. complaints and vigilance data, low-quality user surveys), whilst Specific Methods offer a more proactive approach at gathering relevant clinical data on the device in question (e.g. clinical investigations, device registries, high-quality surveys). MDCG 2020-6 provides an excellent ranked list of different activities which can be conducted.
The EU has released guidance on the templates to be used to develop a PMCF Plan and PMCF Evaluation Report, in MDCG 2020-7 and MDCG 2020-8 respectively. However, expectations for PMCF are quite high under the MDR, and this has been an obstacle which some organisations have found difficult to address. Consult Medical has the knowledge and experience required to put together a solid PMCF Plan required to comply with EU Regulation.
Get in touch today to see how we can help you further in developing your PMCF for your device portfolio.
For more information, please contact the Consult Medical team. 

Performance Evaluation

The Performance Evaluation is a crucial element of a device’s conformity with the general safety and performance requirements (GSPR) of Annex I of the EU IVD medical device Regulation 2017/746 (IVDR), which should take into account the device’s normal conditions of its intended use and evaluate of the interference and cross-reaction and of the acceptability of the benefit-risk ratio (as referred to in Sections 1 and 8 of Annex I). In general, the basis and requirements for the Clinical Evaluation are laid down in Article 56 and Annex XIII of the IVDR.
The Performance Evaluation shall be planned in accordance with the requirements of Annex XII Part A, and be recorded within a Performance Evaluation Plan (PEP). Manufacturers should also have in place an updated Performance Evaluation Procedure, as part of their Quality Management System (QMS), which shall provide an indication for the need of a PEP in order to comply with the IVDR, as part of their technical documentation. The PEP shall take into account the intended purpose of the device, the analyte or marker to be determined by the device, description of the indications, limitations and contraindications, and shall provide a plan for the Post-Market Performance Follow-up (PMPF).
Once these activities are performed, they shall be reported and analysed within the device’s Performance Evaluation Report (PER), which is arguably the most important document within the IVDR technical documentation and which summarises and presents data collected to substantiate claims of scientific validity, clinical and analytical performance.
All devices, even low-risk IVDs, must have a Performance Evaluation Plan and Report in place. The complexity of these documents will vary greatly depending on device risk, device type, and novelty. For higher risk IVDs, one would expect a greater collection and analysis of relevant data, preferably obtained through performance evaluations.
An understanding of Article 61, Annex XIV, as well as relevant MEDDEV and MDCG guidance documents will be paramount in meeting the requirements of the Clinical Evaluation and thus getting your product to market.
Consult Medical specialises in the creation of Performance Evaluation Plans and Reports for all device types, utilising our team of in-house and experienced consultants. The documents we create for you are state-of-the-art and are continuously being updated to reflect changes in interpretation, best-practice, and Notified Body expectations. Furthermore, you may wish to contract Consult Medical to review your Performance Evaluation prior to submission to a NB. Our review will highlight any deficiencies and also provide guidance in closing these gaps, all within one report.
For more information, please contact the Consult Medical team. 

MDR/IVDR Article 13 Importer Service
Under Regulations (EU) 2017/745 (MDR) and (EU 2017/746 (IVDR)

Introducing Consult Medical’s newest service set specifically to answer the needs of medical device manufacturers who are struggling to find a suitable partner without disrupting their well-established supply-chain and logistical routes to shipping to the EU.
The Regulations do not make it mandatory for the manufacturer to appoint an Importer. However, when an importer is not appointed or identified, the default position is that the entity receiving the shipment in the EU automatically becomes responsible for Article 13, and the obligations of these Regulations rest (sometimes unknowingly) with the receiving entity. This also means that the Manufacturer may then be obliged to disclose sensitive information to an entity it would not necessarily have chosen to do so.
It, therefore, makes sense to appoint an independent Importer such as Consult Medical Importer Services.
The Importer under the Regulations does not need to physically inspect the product, nor do they necessarily take ownership or have any property rights of the product to place on the market. Therefore, the products can be arranged for shipping to their EU destination while a third party (Importer) carries out the regulatory checks and verifications on a virtual basis from a location within the EU, before the shipment is dispatched.
As your Article 13 Importer under the MDR/IVDR, Consult Medical Importer Services Limited shall verify that: 
        • That devices have been CE marked.
        • Applicable Declarations of Conformity have been drawn up.
        • The technical documentation exists.
        • Device labelling identifies the Manufacturer, Authorised Representative, and Importer contact details.
        • Where applicable, UDI information is present.
        • Instructions for Use and accompanying information are with the device.
        • Medical devices are registered with EUDAMED in accordance with Article 29 (MDR) and/or Article 26 (IVDR).
        • Where applicable and in accordance with the Regulations, translated labelling and Information for Use is provided.
        • MDR/IVDR device storage or transport conditions do not jeopardise its compliance with the general safety and performance            requirements set out in Annex I. 

In addition, Consult Medical Importer Services shall:
       • Keep a record of complaints.
       • If applicable, report incidents and/or serious risks to Competent Authorities and co-operate as required.
       • Keep available declarations of conformities and certificates for inspection by the authorities. 

For more information, please contact the Consult Medical team.

EUDAMED

The European database on medical devices (Eudamed) is a live directory of economic operators, medical devices, and other related information, which intends to provide access to the general public & healthcare professionals