The EU’s Medical Device Regulation (MDR) came into force on 25 May 2017 and will start fully applying on 26 May 2021 (it has been postponed by one year due to Covid-19 pandemic). MDR will replace current Medical Device Directive 93/42/EEC (MDD) and the Directive on active implantable medical devices 90/385/EEC (AIMDD). The new regulation is meant to increase reliability, safety and performance of the medical devices.
For many medical devices currently placed on the market, additional clinical data will have to be generated to enable CE-marking under the MDR. This process takes time and due to Covid-19 pandemic, many clinical investigations have to be postponed. Are you sure that as a manufacturer, you will be in possession of sufficient clinical evidence by the time the current CE-certificate of your medical devices expire?
The MDR has introduced some significant changes and revolutionized the MedTech world. All medical devices that have been certified under the MDD or AIMDD, must now be re-certified according to the new requirements set by the MDR. “Grandfathering” cannot be arranged!
Manufacturers will have to make sure that they are familiar with the new MDR’s classification rules and update their technical documentation. It might mean that your medical device will have a completely different class and so it will require a different approach from your side.
For class III and implantable medical devices, higher clinical requirements have been introduced. Just to give you a general overview of the current situation... most medical devices that you can find on the market have been certified with few clinical data. Often, Post Market Clinical Follow-up was only based on the update of the bibliographical clinical evaluation obtained during the pre-market phase. Currently, in order to re-certify many medical devices, the Manufacturers will have to conduct a proper pre-market clinical investigation to demonstrate device’s claims in terms of safety and performance. In order to maintain medical devices’ certifications, Manufacturers might be obliged to have a plan of Post-Market Clinical Follow-up studies which will assure that the safety and performance claims are confirmed.
Another important change is, that the Manufacturer will need to identify a person responsible for regulatory compliance, and there will be more surveillance and control by Notified Bodies.
All these changes make it more complicated to develop a new medical device. For already existing medical devices, it will be more complicated to be MDR complaint for re-certification purpose.
As a Manufacturer you will need at least to:
- Identify a person responsible for regulatory compliance (PRRC)
- Classify properly your medical device
- Verify if medical device’s safety and performance requirements are met
- Verify if new requirements for clinical evidence are met
- Make sure that all your business partners (economic operators) are MDR compliant
- Comply with Vigilance requirements (reporting timelines, PMS-Report or Periodic Safety Update Report (PSUR) are drafted).
Does it seem overwhelming and complicated? MTA is here to support you all the way!
The GAP analysis will be performed by MTA’s specialized team with cross-functional roles and an action list will be created for updating your procedures and documentation. MTA will help you to identify the best strategy for your company to perform the MDR transition.
Regulatory Strategy For Other Countries Out Of The European Union
If you are a manufacturer with legal business outside the EU, MTA can support you to obtain CE-mark for your medical device in the EU
If your medical device is already on the US Market, you have already many of the documents needed for the technical file that is needed for the EU MDR Compliance. MTA can help you identifying what is needed to fulfil requirements.
In order to make sure that your medical devices will meet MDR requirements, you need to start working closely with a European Notified Body and prepare appropriate Technical Documentation. MTA can support you with this task.
The aim of EUDAMED is to strengthen market surveillance by providing Competent Authorities with rapid access to information on manufacturers and authorised representatives, medical devices and its certificates. It will serve for registration, notification and dissemination in order to improve transparency of information about medical devices available on the European market. MTA can insert all needed information on your behalf in EUDAMED.
Legal Representative (for manufacturers outside EU and for manufacturers outside Switzerland, in Switzerland)
- Are you looking for a European Authorized Representative (EAR)?
MTA can represent your company to the EU national authorities.
- MTA can verify if your technical documentation complies with the regulations. Once compliance is ensured and completed, we can support you on the way to get CE-mark.
Are you an EU manufacturer and need a Legal Representative in Switzerland?
We have our registered office in Switzerland so we can represent you here!
PRRC: Person responsible for Regulatory Compliance
MTA can assign a person (or team) that will be your responsible for regulatory compliance (PRRC) who will ensure that your technical documentation is compiled and maintained and that all your post market surveillance and obligations are met.
Regulatory Affairs Training
European Medical Device Regulation training: see event of 27th of April 2021
If you have no legal subsidiary in the EU, you need to appoint a European Authorized Representative (EAR). MTA can be your EAR, having registered offices in Italy.
A legal subsidiary in Switzerland is needed for notification to the Competent Authority Swissmedic. MTA can cover this task for you having registered offices in Lugano.
Are you searching for a Regulatory Agent in the USA? MTA has a global network of collaborating companies and can support you with this service.
Are you searching for a Regulatory Agent in China? MTA has a global network of collaborating companies and can support you with this service.
Notified Body Selection
Notified Bodies are responsible for validation and (re-) certifying Medical Devices allowing products market access in Europe. MTA can help you with the selection of the most appropriate Notified Body. Please check HERE for all MDR designated Notified Bodies
Interaction with Notified Bodies and Competent Authorities
For many of activities required by MDR, interaction with Notified Bodies and Competent Authorities is a fact. MTA can help you in interacting with both on your behalf.
Support To Manufacturer’s Risk Management Team For Medical Device Risk Analysis According To Iso 14971
To fulfil the requirements of international standards and ensure that your company will place a safe, effective product on the market, MTA can support your team in creating a risk file for new devices; in case your medical device is already on the market, MTA can support you in performing a risk analysis on existing risk management files, both according to ISO 14971.
Product’s Leaflet And Labels Texts Preparation And Review
MTA can help you with your product’s leaflet and labels text drafting and review according to MDR.
Technical Documentation Preparation And Maintenance (Technical File / Design Dossier)
With the introduction of the MDR, the expected quality of the technical documentation has increased, especially when it comes to clinical data, which will need to be robust enough to sufficiently substantiate any claim of your medical device. MTA can help you in setting-up and maintaining the technical documentation for your medical device in line with MDR requirements.
Scientific Literature Review
To understand the benefit and risk ratio of a medical device, the evaluation of existing clinical data is very important. Review of clinical literature is important, to identify eventual gaps that will need to be addressed in the Clinical Evaluation of a medical device, and to understand if an eventual clinical investigation is needed. MTA can support you in regular review of the existing scientific literature.
Clinical Evaluation File
The Clinical Evaluation serves to verify that the medical device can be used in total safety and performs as intended when used according to the instructions for use.
MTA can offer support during all phases of Clinical Evaluation and help you with writing Clinical Evaluation Plan and Report needed for obtaining your CE-Mark. After your device has been registered on the European Market, MTA can support you with your CED update by inserting data from Post-Market Surveillance (including data obtained during PMCF), newly discovered risks or indications, and developments in the clinical field.
Post Market Surveillance Plan/Report
Market Surveillance is needed for the whole life-cycle duration of the medical device, as clinical data gathered in the pre-market phase may be not sufficient to identify rare events or incidents that are only evidenced during the real-world use.
MTA’s specialized team can help you in preparing a Post Market Surveillance Plan and Post Market Surveillance Report to make sure that your product is constantly supervised.
Post Market Clinical Follow-up-PMCF
Post Market Clinical Follow-up (PMCF) is an active observation and collection of clinical data related to your medical devices after having placed it on the market to identify any emerging or previously unknown risks and to confirm the safety and performance of your device throughout its lifetime.
It is meant to present a real-world evidence and is a part of the Post Market Surveillance Plan.
MTA’s specialized team can help you in preparing a PMCF-Plan and PMCF Report for your medical device.
In case there isn’t sufficient clinical data, Post market Clinical Follow-up data can be obtained by performing a Post Market Clinical Follow-up Investigation (see more).
Post Market Vigilance
Post Market Vigilance is part of the Post Market Surveillance,
MTA can help you setting-up a Post-Market Vigilance process for your company or you can decide to delegate Post-Market Vigilance activities to MTA. MTA can also be the first point of contact for the end-users for adverse events and/or complaints reported spontaneously.
In case of Clinical Investigations MTA can file the occurred events in a database, analyse the causality of the events together with the Principal Investigator and report the event on your behalf to the involved Competent Authorities and the Ethics Committees, if applicable.
Part of Vigilance activity is also drafting regular Reports about the outcome of the Vigilance Process: Periodic Safety Update Reports (PSURs) or Trending/Incidence Reports. MTA can help you in drafting these reports and submit them to the Competent Authorities.
Summary Of Safety And Clinical Performance (SSCP)
The Summary of Safety and Clinical Performance SSCP is intended to provide public access to an updated summary of clinical Data and other information about the safety and clinical performance of your medical device.
MTA can help you with drafting and maintaining your SSCP updated
Give support for Quality Management System set-up and maintenance
For manufacturers of medical devices, it is mandatory to have a Quality Management System (QMS) in place. MTA supports you with the set-up of your ISO 13485 compliant QMS and its maintenance.
Support In Product Development Including Clinical Development Plan
MTA can support you from the very first step during your product development. We can help you to assess what is needed to develop your product, decide which Clinical Investigations are needed to confirm performance and safety claims, by preparing a Clinical Development Plan and help you on the way to obtain the market authorization for your product.
Clinical Trial Documentation
MTA can help you with the Medical Writing of Clinical Trial documentation, such as Clinical Investigation Plans, Patient information and Consent Forms, Investigator’s Brochure (IB), Clinical Investigation Report, Recruitment material (Promotional material), Site Agreement Development and negotiation, Essential Documents Collections for Investigator Site File/Trial Master File set-up and maintenance during the Clinical Investigation. MTA ensures compliance with European standards (ISO 14155/GCP) and regulatory compliance.
MTA has a big network of clinical sites and can advise on site selection strategy and has an internal feasibility specialist that has gained much experience in performing feasibility assessments at sites before their selection. If you have already selected the sites you want to work with, we can prepare them for initiation by training and education.
Clinical Trial Submission
MTA has experience in world-wide study submission and can help you out in adapting study documents to the local requirements if needed and perform submission of the study to Ethics Committees (ECs) and Competent Authorities (CAs) on your behalf.
MTA’s Project Managers will overview your studies by coordinating the whole project, from the development of documentation, study setting-up, the management of the clinical trial itself (coordination and management of the whole team involved: Medical writer, statistician, feasibility specialist, Regulatory Affairs Manager, CRAs, Medical Reviewer etc., until the final report delivery. MTA’s project manager will be your main contact person.
MTA can collect the adverse events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs) and Serious Adverse Device Effects (SADEs) during the Clinical Investigation and perform Safety Reporting to Ethics Committees and Competent Authorities on your behalf respecting the timelines defined by the MDR
Monitoring Services (on-site and remotely)
MTA has experience in performing all kind of monitoring visits (Pre-Study Visits, Site Initiation Visits, Regular Monitoring Visits and Close-Out visits) that can be performed on-site and if needed also remotely. MTA has dedicated CRAs for your studies that will be the principal contact with the Investigator at site and will perform regular remote monitoring management of the site itself, to solve pending issues discovered during monitoring visit, answer to questions, follow-up on e-queries etc.
e-PRO (electronic-Patient Reported Outcome)
e-PRO is a scientific validated patient survey tool to capture information directly from the patients. It is a great tool that can be used during your product surveillance process and the information can be obtained in real-time. Depending on your product and your necessity, MTA can design and develop an e-PRO which will assure the collection of key information from the patients. The kind of information that you can collect can vary from product specific information, through pain scale, time of recovery/healing, patients’ satisfaction to collection of potential Adverse Events. MTA has also developed a way of correspondence between e-PRO and the Electronic Data Capture so that the Investigational Sites can receive patients-reported information directly in the eCRF.
Data Management & Statistics
MTA provides project specific data management documentation to produce accurate and robust clinical databases for analysis and reporting. The services include:
- Data Management Plan development
- Case Report Form (CRF)/eCRF design and review
- Data Validation specification (Data Validation Plan)
- Edit checks programming and testing
- Ongoing data review and equery management
- Customized status reports/trackers
MTA’s statisticians are experienced in defining the statistical aspects of clinical trials protocol, determining trial’s sample size, developing Statistical Analysis Plan and performing statistical analysis of clinical trial data in general and in advanced statistical analysis methods for power calculations, interim & final statistical analysis.
- Medical coding of Adverse Events (MedDRA)
- Reconciliation of Serious Adverse Events and other data