MEDICAL & REGULATORY WRITING
W&P Consulting provides medical writing and editing services for a wide variety of regulatory documents, ranging from pre-IND submissions through post-marketing commitments. We have extensive experience supporting both single-document and large-scale submissions across a diverse assortment of indications. Our writers are familiar with regional healthcare authority requirements, ICH and GCP guidelines, and best industry practices, and our documents are prepared in eCTD format. Premier Consulting’s regulatory medical writing services include:
Regulatory consulting services include:
- Regulatory/health authority submission documents for the FDA and EMA
- Regulatory review – consistency of message, regulatory commitments
- Clinical documents – support for labeling
- Document quality control – data integrity
Regulatory Document Services
- Investigational new drug, new drug application, and market authorization application modules (2.4, 2.5, 2.6, 2.7)
- Investigator brochures
- Pre-IND meetings
- Development safety update reports
- Regulatory responses
- Pediatric plans
- Integrated summaries of safety and integrated summaries of effectiveness
- Briefing books
- Lay summaries for the European Union
- Health authority meeting materials
Clinical Document Services
- Protocols
- Protocol amendments
- Clinical study reports
- Annual reports
- Narratives
- Executive summaries
EUROPEAN AUTHORIZED
REPRESENTATIVE SERVICE
Art. 2 (32) MDR / Art. 2 (25) IVDR
Art. 11 (2) MDR / IVDR
Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative.
The EAR is a registered economic operator. The EAR services under the new regulations will include:
- Provision of an authorised European address
- Verification activities regarding EU declaration of conformity, technical documentation and appropriate conformity assessment procedure
- Keeping available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued by the notified body
- Verification of compliance with all registration obligations for the EAR and manufacturer
- Interaction with competent authorities providing all relevant information and documentation necessary to demonstrate the conformity of a device as well as product samples on demand
- Liaison between competent authorities, manufacturer, importer, distributor in vigilance aspects
- Cooperation with the competent authorities on any preventive or corrective action taken to eliminate or mitigate the risks posed by devices;
- Information of the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected product related incidents
Our EAR services also include
- Access to free sales certificate / EAR under other specific regulations for non-medical devices
- In-house and online trainings
All clients have permanent and safe access to our document server system. Make use of our personalised EAR services. Our EAR services meet the requirements of the new regulations and provide you full flexibility in your European distribution network.
UK Medical Device Importer Services
Wondering why you need a UK importer? After Brexit, the UK is no longer required to adopt European medical device regulations. That means the EU MDR and IVDR do not apply, and you must follow the UK Medicines and Medical Devices Act (MMDA). This UK regulation requires you to appoint a regulatory compliance importer for shipments to England, Scotland, or Wales – collectively called Great Britain.
By working with W&P Consulting as your single designated Great Britain importer, you avoid asking your distributor or distributors to take on this responsibility and therefore maintain more independence at a minimal cost. W&P already fulfills the role of EU importer and Swiss importer for medical device companies, so we have processes established to verify your compliance quickly and seamlessly with the UK requirements.
Regardless of whether you are selling legacy devices holding existing CE certificates under the MDD/IVDD, or devices with CE under the MDR/IVDR, or you already have UKCA marking, you still require a Great Britain importer based in the UK.
Meet UK Requirements Precisely and Smoothly with Experts
As Your Delegated UK Importer, We Will:
- Verify that devices sold in Great Britain carry the UKCA mark
- Verify UK declaration of conformity and technical documentation
- Verify labeling, UDI, and accompanying information (IFU)
- Check to ensure that the manufacturer is identified and UK Responsible Person has been assigned
- Verify that MMDA storage and transportation requirements are fulfilled
- Maintain a register of complaints as required by UK law
- Inform manufacturer if device provides serious risk or is not in conformity
- Check to ensure that devices have been registered with MHRA
- Report serious incidents or risks to MHRA; cooperate on CAPA issues
EU Regulatory Importer Representation Services
Are you wondering why you need to consider an EU MDR/IVDR importer when you already may have distributors to take on the role of importer? The reason is that Article 13 of the EU MDR and IVDR now allocates specific responsibilities and obligations to the importer, the only other economic operator that takes on the responsibility for placing your devices on the European market if the legal manufacturer does not have a place of business in the Union. To take on the responsibility and obligations of the importer as defined in the MDR/IVDR, the importer is not required to take physical possession of your devices, but they do play a vital role in device compliance, post-market surveillance (PMS), vigilance, and traceability of devices.
By engaging W&P as your designated independent EU MDR or IVDR importer, you are entrusting this role to expert regulatory professionals who will ensure your ongoing compliance by efficiently performing the responsibilities and obligations of the importer.
Regardless of whether you are selling legacy devices holding existing CE certificates under the MDD/IVDD or devices with CE under the MDR/IVDR, the role of the importer is required by the MDR/IVDR.
Optimize compliance with W&P as your trusted EU MDR and IVDR importer for medical device and In Vitro Diagnostics (IVDs) manufacturers.
As Your Delegated European Importer We Will:
- Check EUDAMED registration of all economic operators
- Verify that devices placed on the EU market include CE Marking
- Verify that EU declaration of conformity and technical documentation exists
- Verify instructions for use and accompanying information with the device
- Verify labeling includes manufacturer, EC REP, and importer contact details
- Verify that MDR/IVDR storage and transportation requirements are fulfilled
- Maintain a register of complaints as required in Article 13
- Report serious incidents or risks to the competent authority, if applicable
- Maintain traceability of device in the supply chain
CE marking
Given the stringent requirements on patient safety and device performance, accessing the European market brings challenges that can delay your product launch. It is critical to work with a Notified Body that understands the industry and has the experience to review and confirm your product’s readiness for market.
W&P is a leading Notified Body achieving full-scope designation under MDR and IVDR. We review your medical devices and IVDs to assess conformity against European Regulations by offering a range of flexible product review services providing you with efficient pathways to bring your product to market.
What is CE marking?
CE marking is the medical device manufacturer’s claim that a product meets the General Safety and Performance Requirements (GSPR) of all relevant European Medical Device Regulations and is a legal requirement to place a device on the market in the European Union.
To understand which requirements you need to meet, you must classify the device and identify the appropriate conformity assessment route for your product. This dictates the required activities to demonstrate conformity.
We will review the route you chose to confirm its suitability, and work with you to execute the most efficient review process for the selected route. Our trusted review processes allow you to build reliability and confidence into your CE marking project planning.
Before placing on the market
In order to place a product on the market within the European Union, a number of requirements must be met, which are set out in European directives or regulations. The detailed requirements appear already at the design stage, through production, quality control and product registration.
- Verification of qualification and classification
Correct qualification and classification of a medical device is crucial for the determination of an appropriate conformity assessment procedure and allows to avoid legal complications and additional costs.
- Clinical evaluation
Clinical evaluation is the procedure for collecting, evaluating and analysing clinical data on a medical device to verify that the clinical evidence proves the safety and effectiveness of the medical device.
- Selection and contact a notified body
A key step is the selection of a notified body that is suitable to certify the manufacturer’s products for: classification, specific codes and conformity assessment procedure.
- Product registration
Prior to placing a medical device or in vitro diagnostic medical device on the market, a registration or notification must be made with the relevant Competent Authority.
- Verification of the technical documentation
Verification that the technical documentation is prepared in accordance with the applicable law is an important step before starting the certification or notification process.
- Risk management and analysis
In order to place a product on the market, the risks associated with the products must be identified, assessed and evaluated, and the effectiveness of the risk management process must be monitored.
- Analysis of harmonised standards
Identifying and performing the necessary tests in accordance with harmonised standards allows you to assess whether the product is effective and safe for use.
- Preparation of the technical documentation
Properly prepared technical documentation ensures compliance with the overall safety and performance requirements of the medical device.
After placing on the market
Following successful completion of the product conformity assessment process, the Manufacturer shall ensure that the surveillance and control activities for the manufacture of the devices, as well as the related post-market surveillance and observation activities, are carried out in a manner consistent with the current legal status.
- Post market surveillance
As part of market surveillance, procedures should be established and regularly updated to actively collect and review the post-marketing experience gained.
- Vigilance
Vigilance consists of identifying medical incidents and events and carrying out corrective actions related to device safety.
- Certificate of free sale
The certificate of free sale is a document facilitating the export of medical devices and in vitro diagnostic medical devices outside the European Union.
Medical Devices Regulation (MDR)
The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices (MDs) in Europe, and compliance with the regulation is mandatory for MD companies that want to sell their products in the European Union. The European Medical Device Regulation (MDR), which was adopted in April 2017, changes the European legal framework for medical devices and introduces new principal and supportive responsibilities for EMA and for national competent authorities in the assessment of certain categories of products. The Regulation entered into force in May 2017 and had a staggered transitional period. The MDR replaces the existing Directives for medical devices (93/42/EEC and 90/385/EEC).
Key changes from MDD to MDR
If your company was already compliant with the Medical Devices Directive (MDD), you may want to update this as the MDR represents brand new regulations with a significant number of changes. Compared with its predecessor, the MDD, the new European MDR is less focused on the pre-approval stage of medical device manufacturing, and instead, promotes a lifecycle approach to medical device regulation. While the old MDD essentially served as a manual for how medical device companies could get their CE marking and get to market, the new regulations encourage policies and procedures that elevate the responsibilities of medical device companies for their products throughout the entire product lifecycle.
Key dates for MDD-MDR transition
- 26 May 2021-25 May 2024: Certificates issued under the AIMDD/MDD before the MDR fully applies may remain valid until 25 May 2024 under certain conditions.
- From May 2024: All devices placed on the market must be in conformity with the MDR.
- 26 May 2024-27 May 2025: MDD devices which were already placed on the market may continue to be made available
What is our role as W&P in the process?
We provide full service CRO for the clinical performance studies of MDs and we consult manufacturers of MDs on the planning, preparation, execution, and reporting of performance evaluations for existing as well as novel MDs to ensure compliance with MDR. W&P prides itself with providing the very best services for planning, writing, and documentation of evaluations and reports provisioned in MDR. We also provide resources for the manufacturers to help them navigate the system, keep current with the changes in the regulation, and train their personnel responsible for regulatory compliance.
In Vitro Diagnostic Medical Device Regulation (IVDR)
The IVDR entered into force on 26 May 2017, and fully applies from 26 May 2022. CE Certificates issued under the Directive before 26 May 2022 may remain valid for up 27 May 2025. The IVDR introduces a new system of risk-based classification (Class A, B, C,D). While 70% of IVDs entering the EU Market under the IVDD were considered “self-declared”, under the IVDR 70% of IVDs will need to mandate the intervention of a Notified Body accredited under the IVDR in order to obtain the CE Mark and enter the EU market.
Approach IVDR compliance with confidence
Respected manufacturers of in vitro diagnostic devices value certification as a way to demonstrate their commitment to the highest standards of quality, meet European market requirements and adorn the CE marking.
Manufacturers are facing new requirements under IVDR 2017/746 issued by the European Commission (CE), which include more stringent mandates such as increased accountability, transparency, detailed documentation and regular filings to the new EUDAMED database.
The most significant change is the new product classification system, and the requirement that manufacturers of IVD devices (Class A exempted) must consult a Notified Body for approval.
Successful transition to IVDR compliance requires manufacturers to prepare for reliable documentation of performance, high safety standards and effective risk management, in addition to conducting comprehensive product inspections while on (and prior to entering) the EU markets.
We provide comprehensive services for your initial or transitionary compliance with the new In Vitro Diagnostic Devices Regulation. Our full range of medical testing and certification services enables us to offer you a tailored service suited to your products and needs.
CONTACT US TO LEARN MORE ABOUT THE SPECIFICS AND TIMING OF IVDR 2017/746, AND HOW IT AFFECTS YOUR BUSINESS.
Preparatory recommendations for the IVDR compliance process
Pre-compliance checks (general recommendation):
- Classify products
- Establish working groups to setup UDI numeration strategy
- Perform gap analysis
- Close gaps in QMS (special focus on post-market surveillance & risk management)
- Close gaps in technical documentation (special focus on performance evaluation & clinical evidence)
- Coordinate with the Notified Body
Gain access to European markets with IVDR compliant products
Securing your product compliance with the new EU regulation is mandatory for CE marking and entry into European markets. CE mark certificates are issued based on a successful conformity assessment, and shows your commitment to excellence and fulfillment of European market requirements to authorities and customers.
The CE mark on your in vitro diagnostic device can also increase your competitiveness on the global market beyond EU nations. Our customers enjoy a single-source provider experience from around the world, and have access our network of highly qualified medical device experts sitting locally in major markets.
US FDA Consulting for Medical Device and IVD Manufacturers
As the US Food and Drug Administration’s medical device and IVD review process becomes more complicated, partnering with an experienced FDA consultant can make a significant difference in your market authorization and compliance efforts.
Whether your goal is to implement a quality management system that complies with the FDA Quality System Regulation (QSR) or obtain 510(k) premarket notification clearance, a skilled FDA consulting firm can assist you in meeting all US regulatory requirements.
FDA consulting services we offer:
- FDA 510(k) submissions for obtaining FDA clearance
- FDA Investigational Device Exemption (IDE) submissions for US clinical studies
- FDA Requests for Classification and Requests for Determination
- FDA Pre-Submission (Pre-sub) meetings
- FDA QSR Consulting (21 CFR Part 820) for medical device and IVD manufacturers
- US Agent representation for manufacturers based outside the US
- QSR (21 CFR Part 820) audits for medical device companies and their suppliers
- FDA Form 483 Warning Letter analysis, response, and recovery
Why choose W&P as your FDA consulting firm?
- We offer effective FDA regulatory support for all sizes of firms, from small, start-up medical device companies to large, multi-divisional corporations.
- Our FDA consulting services are fully tailored to address your particular business needs.
- Our FDA consulting and project management teams coordinate efforts to deliver your services on time and within budget.
- We maintain constant accessibility and support both on- and off-site during the course of your FDA consulting project.
Contact us today for more information on our FDA consulting services.
ICC (In-Country Caretaker) Service
ICC (In-Country Caretaker) service is a service that is entrusted with the management and import of domestic product licenses on behalf of a foreign manufacturer of medical devices/medicine. The ICC service allows foreign manufacturers to obtain legal representatives similar to branch offices without much initial investment costs while the distributor is able to focus on sales and marketing, and away from the duties such as strict registration and licensing management. W&P acts as your total business representative in Korea and lead an even more effective business structure.
How can W&P ICC service help?
Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative.
The EAR is a registered economic operator. The EAR services under the new regulations will include:
Fast entry into the market
- Permission of items and finding domestic dealerships are carried out at the same time
- Establishment of a domestic business model specialized in products
Multiple Distribution Partnerships
- Work with a multiple number of distributors or sales agents
- Flexible to change/expand sales channel without license issue
- Separation of item licensing management tasks and sales and marketing activities
Securing business continuity
- Secure the actual ownership of product license
- Product license management with high level compliance
Reasonable Service Fees
- Establishing service costs based on business scale, import volume, revenue, etc
- Suggestion of customized logistics costs
Act as a cost-effective domestic branch
- Reduce initial infrastructure investment costs when establishing a branch office
- No need to hire RA/QM/PV manager and Supply Chain manager
- Minimize fixed operating costs such as office and warehouse space
We are also open to other requests. We invite you to contact us to discuss details of our future cooperation.
