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US Agent

Every company that is involved with production or distribution of medical devices intended for the USA (manufacturer, packager, exporter, importer, specification developer, etc) must: register with US FDA, list the devices by category, and if foreign, must have a US Agent.

Each year by December 31st, each registered company must renew its registration.

Medical Device Listing

All medical devices that are manufactured and imported into the U.S. are required to be listed with the FDA. Firms that are required to list their devices are those that:

• manufacture
• repackage and relabel
• develop specifications
• reprocess single-use devices
• remanufacture
• manufacture accessories and components sold directly to the end user

A separate device listing form must be submitted for each type of device.

Medical Device Listing as required by the US FDA to export your product to the USA

What Is Medical Device Listing

Most medical device establishments required to register with FDA must also identify to FDA the devices they have in commercial distribution including devices produced exclusively for export. This process is known as 'medical device listing' and is a means of keeping FDA advised of the generic category(s) of devices an establishment is manufacturing or marketing. The regulations for medical device listing are provided in 21 CFR 807.

Each generic category is represented by a separate classification regulation found in Title 21 Code of Federal Regulations Parts 862-892 or FDA assigned device name. Each regulation number or device name is associated with one or more product codes. Regulation numbers with more than one product code identifies the product in further detail. For example, "Manual Surgical Instruments for General Use," 21 CFR 878.4800, contains several product codes including GAB (disposable suturing needle), GDX (scalpel), HTD (forceps) and HRQ (hemostat).

Listing of a medical device is not approval of the establishment or a device by FDA. Unless exempt, premarketing clearance is required before a device can be marketed (placed into commercial distribution) in the U.S.

All device types classified as exempt from the Premarket Notification 510(k) requirements are subject to the limitations of exemptions. Limitations of device exemptions are found in the device classification chapters in 21 CFR xxx.9, where xxx is replaced with Parts 862-892 (e.g., 862.9, 864.9, etc.). Please be aware that it is your responsibility to ensure that you meet the exemption criteria and that your device does not exceed the limitations of exemption. If your device exceeds the limitations of exemption, you must submit a 510(k) and receive a letter from FDA stating that your device may be commercially distributed in the U.S. prior to marketing your device.

While there is no separate fee for listing your device, device listing is completed as part of the annual registration process. Many device establishment types are subject to an annual registration fee.

Who Must List

An owner/operator of an establishment not exempt under 21 CFR 807.65 who is engaged in the manufacture, preparation, propagation, compounding, assembly or processing of a medical device intended for commercial distribution (marketing) is required to list its device with FDA within 30 days of entering the device into commercial distribution in the U.S. This includes manufacturers, repackagers and relabelers, specification developers, reprocessors of single-use devices, remanufacturers, U.S. manufacturers of export only devices, and manufacturers of accessories and components that are ready to be used for any intended health-related purpose and are packaged or labeled for commercial distribution for such health-related purpose (that is, manufacturers of components or accessories that are intended to be sold or leased directly to the end user.) (21 CFR 807.20). Foreign manufacturers and foreign exporters must list their devices prior to importing into the U.S.

Domestic contract manufacturers and contract sterilizers are required to register their establishment and list their devices if they commercially distribute the devices. Initial importers located in the U.S. are required to register their establishment; they are not, at this time, required to list their devices.

The following establishment types are required to list their devices:

Contract Manufacturer

Manufactures a finished device to another establishment's specifications and places the device into commercial distribution.

Contract Sterilizer

Provides a sterilization service for another establishment's devices and places the device into commercial distribution.

Manufacturer

Makes by chemical, physical, biological, or other procedures, any article that meets the definition of "device" in section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act.

Remanufacturer

Processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or in any way changes the intended use.

Repackager and / or Relabeler

Repackager: Packages finished devices from bulk or repackages devices made for the establishment by a manufacturer into different containers (excluding shipping containers).

Relabeler: Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name.

Specification Developer

Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment's name by a contract manufacturer.

Foreign Exporter

Exports or offers for export to the United States, a device manufactured or processed by another individual, partnership, corporation or association in a foreign country, including devices originally manufactured in the U.S. A foreign exporter must have an establishment address outside the U.S.

Reprocessor of Single-Use Devices

Performs remanufacturing operations on a single-use device.

U.S. Manufacturer of Export Only Devices

Manufactures medical devices that are not sold in the U.S. and are offered solely for export to foreign countries.

Note: Initial distributors (importers) located in the U.S. are not required to list their devices. However, they are required to register their establishment. Refurbishers and domestic distributors are not required to list their devices or register their establishment.

When to List

When an owner/operator of a domestic establishment enters into an activity that requires registration, device listing much be completed at the time of registration for the establishments that are required to list as discussed above under "Who Must List."

The owner/operator must also submit a device listing when it introduces a device into commercial distribution that has a classification name or product code that is not currently listed.

Foreign establishments must to submit device listings prior to exporting their devices to the United States. Registered establishments are also required to review and update their listing information once per year, during the registration period of October 1st to December 31st of each year. You can update your device listing(s) at any time. We encourage you to update your device listings at time the change occurs.

Sunglasses, Spectacle Frames, Spectacle Lens and Magnifying Spectacles

Sunglasses, spectacle frames, spectacle lens, and magnifying spectacles are medical devices exempt from the Premarket Notification 510(k) submission to the Food and Drug Administration (FDA). Although these devices are 510(k) exempt, several other FDA regulations apply:

• U.S. manufacturers and initial U.S. distributors (importer) must register their establishment with FDA;
• foreign manufacturers must register their establishment with FDA and name a United States Agent;
• manufacturers must list their device with FDA.
• manufacturers must meet Quality System (QS) requirements,
• the lens for spectacles and/or sunglasses must be certified as impact resistant.

How to List

All listing information (new, updates or annual review) must be submitted electronically unless FDA grants you a waiver. Electronic registration and listing is completed through FDA’s United Registration and Listing System (FURLS).

Updating Listing Data The official correspondent of each establishment is responsible for keeping their listing records current. You can update your device listing(s) at any time through FURLS.

The owner/operator must submit a device listing when it introduces a device into commercial distribution that has a classification name or product code that is not currently listed. We encourage you to update your device listings at time the change occurs. Updating is required when one of the following occurs: All models or variations of a listed device is removed from commercial distribution. That is, the product is discontinued. The commercial distribution of a previously-discontinued device is resumed. There is a change in the type of activity performed on a device, such as where it is being manufactured. You are encouraged to identify proprietary names or trade names to distinguish various models of the same device.

<< Content copyright US FDA and obtained from the US FDA website at www.fda.gov >>

What is the practical impact for a medical device manufacturer that has a UK-based Authorized Representative?

This is going to have a huge impact if a manufacturer has their Authorized Representative (EU AR) currently based in the UK. 

As indicated in the European Commission notice, there is an Implication of the Brexit is that an UK office based AR will no longer be valid under EU law. We suggest that manufacturers must discuss the situation with their AR. Alternatively, contact a professional (qualified, registered, and has an PRRC in their team) AR service provider.

The significant impact for manufacturers is that all product labeling must identify the Authorized Representative, including their address and contact information. If a company sells thousands of products with a UK AR, the change to labeling alone is a significant impact.

If you are based in the UK, it’s important to remember that we anticipate that as of March 30, 2019, you will need to appoint an EU-based Authorized Representative, and that AR needs to be added and/or updated on your product labeling.

What we do?

We assist manufacturers and consultants by delivering integrated business solutions, which include European Authorized Representative (AR) services (MDR / IVDR) and Legal Representative Services (pharma companies).  We act as legal entity towards the European Competent Authorities to ensure all issues will be handled effectively and in compliance of the European requirements. 

We representate your company to all member states of the European Union (EU) as required by law: 'Act and to be addressed by authorities and notified bodies in the EU instead of you as manufacturer, with regard to the obligations of the manufacturer under EU Directive, as and when required ‘.  

A manufacturer of a medical device or of an in vitro diagnostic device cannot simply have a post office box located in the EU, but is obliged by EU law to appoint an authorized representative to competent authorities. In this way, there is no need to open an office within the EU.

As your EU Authorized Representative (AR) we are legally responsible and accountable for:

• Retention of all technical documentation and certificates so that this can be readily provided  to both Competent Authorities (CA) and Notified Bodies (NB)
• Notification and reports concerning Post-Market Clinical Follow-up (PMCF) issues, (i.e. incident reporting, product recalls and Field Safety Corrective Actions (FSCA) to any CA according to the local requirements and to Meddev guidelines in each EU Member state
• Notification of significant changes of your medical device to any CA
• Notification of clinical investigations to any CA
• Maintenance of clinical reports required by any CA

As your EU AR it is required that our contact information must be included in all product related communication materials, such as product labels, IFU, inserts, and manuals.

As your EU AR we

• represent you as a non EU manufacturer to all EU member states, including UK after the Brexit
• submit to the electronic system information as referred to in Annex V (part A) before your medical device is placed on the market and or before applying to a notified body (MDR requirement)
• notify you when your CE-marked medical devices is registered as approved by any Competent Authority
• maintain your technical product documents and files, as required by the MDR (art 9,3)
• provide Competent Authorities all information and documents necessary to demonstrate the conformity of your medical device
• cooperate with the Competent Authority on any corrective action
• notify EU Competent Authorities in case of severe adverse event (SAE) and serious incidents
• interface on your behalf between Competent Authorities, Notified Body and your distributors or end-users
• monitor changes in regulatory requirements and contact you when there are issues that deserve your attention
• perform an annual review of your technical file content to confirm the accuracy of the data
• Co-sign the Declaration of Conformity (DoC)
• support you to arrange covering product liability as required in the MDR

Optional services we can provide may include the following:

• Post market Vigilance and feedback
• Apostille and legalization of Free Sales Certificates (FSC)
• Post market clinical evaluation
• Handling notifications of clinical investigations
• Supply chain control
• Preparations for unannounced audits or inspections
• Product liability insurance
• Risk management
• Logistics solutions

 MRM is proud to be a full Associate of EAAR  , which stands for Quality, Reliability, and Professionalism. 

If you already have an EU AR, but would like to maximize the services you receive, then engage MRM; we provide a smooth and transparent transition. Our transition procedure is seamless and simple. Please contact  This email address is being protected from spambots. You need JavaScript enabled to view it. for a quotation.  

ISO 13485:2016 (ISO/TC 210)

The new ISO 13485:2016 (Published February 25, 2016) specifies an effective framework to implement and to be in compliance of regulatory requirements specific for medical technology organizations and or related service providers.

Implementation of ISO 13485:2016 ensures effectiveness of operational processes such as research, design & development, production, installation, delivery of medical devices. Further, adequate implementation ensures the medical devices are safe for their intended purpose. The ISO 13485:2016 is also applicable across the whole supply chain and seeks the entire lifecycle of a medical device.

Implementation of ISO 13485:2016 ensures compliance with regulatory requirements, adequate risk management, and best practice for quality and safety.

In the process of implementation we’ll suggest to consider to implement also relevant key requirements of the Medical Device Regulations (MDR) and the In Vitro Diagnostic Regulations (IVDR). The impact of the mandatory requirements of ISO 13485:2016, the MDR (MDD and AIMDD) and the IVDR (IVDD) is significant! Consequently requires these standards higher investments from medical technology manufacturers and related companies to be in compliance with the new EU regulations & requirements.  Although the transition period of maximum three years we advise you to anticipate on these changes in a pro-active and timely manner to avoid having CE certificates suspended or revoked.

In summary, there are basically five sections in the standard of the ISO 13485 where major changes have been made:

Regulatory requirements

The first section establishes an emphasis on regulatory requirements that we see across the standard. This includes not only the local requirements that apply to your facility, but if you are an organization that commercializes its products globally, you also need to take into consideration all relevant international requirements. There are many references to this throughout the ISO 13485:2016 standard.

Risk management

Another theme that permeates the standard is the need to incorporate risk management into all the main quality system processes within your organization. Almost everything you do needs to be based on that risk, justifying that what you are doing is adequate and conforms to what you defined as part of your design and production activities.

Validation, verification, and design transfer 

The ISO 13485:2016 standard puts a lot more structure into place surrounding these activities. You must have plans in place and documented evidence to show what you have been doing for validation, verification, and design transfer activities.

Outsourced processes and supplier control

The ISO 13485:2016 standard asks organizations to do a lot more when it comes to outsourcing processes and putting into place controls for assessing your suppliers — again based on risk.

Feedback

Finally, the ISO 13485:2016 requires you to monitor and measure the performance of your quality management system not only during production, but also post-market. You also have to incorporate those activities as part of your risk management process.

Interconnection of other requirements

The linkage between all the different clauses within the standard is improved. Everything is more interconnected. Expectation is that you have systems in place that allow you to demonstrate conformity across the requirements in a more streamlined manner. For example, there is not just one section that discusses risk-management or regulatory requirements or CAPA — instead we see these topics addressed throughout the standard. It is a much more integrated approach.

If you need support, training and or if you would like to maximize your QA / RA services you, please contact  us via This email address is being protected from spambots. You need JavaScript enabled to view it.. 

Als producent van een medisch hulpmiddel bent u eindverantwoordelijk dat uw CE gemarkeerde medische producten in overeenstemming zijn en blijven met die EU Directieven die van toepassing zijn. Het maakt hierbij niet uit of u de productie van een deel of van componenten aan anderen uitbesteedt hebt.

CE Markering

Verkrijgen van een CE markering vereist een tweetal items: veelal ISO 13485 certificatie van het kwaliteitssysteem; en review van het Technisch Dossier.

Het kwaliteitssysteem is primair gericht op controles in ontwikkeling en productie en vereist daarmee ook het ontwerpen van standaard procedures (SOP's). Tijdens het certificatieproces zal de Notified Body (NB) de mate van overeenstemming tussen de werkelijkheid en de SOP's verifiëren en beoordelen.

Training van personeel, identificatie en traceerbaarheid van producten, specificaties in het ontwerp, borging in productie en risico management zijn belangrijke onderwerpen die in het kwaliteitssysteem geborgd dienen te zijn en ook bijzondere aandacht krijgen van de NB.

Het Technisch Dossier dient te bestaan uit overzichten van informatie en data die aantonen dat het medisch product voldoet aan geldende veiligheid- en prestatie-eisen die in verschillende standaarden zijn vastgelegd. Typische aanvullende informatie die in het technisch dossier behoort opgenomen te zijn: biocompatibiliteit, sterilisatie en productprestatie.

Het risico management dossier omvat een samenvatting zoals deze is vastgelegd in de ISO 14971; en een klinisch evaluatierapport gebaseerd op literatuuronderzoek of data verkregen bij uitgevoerd onderzoek dan wel via clinical trials.

Risico Classificatie in het EU Proces en de impact op de CE Markering

In de EU kennen we een viertal risicoklassen, namelijk I (Is - Im), IIa, IIb, III. De beschrijving van ' beoogd gebruik' - ofwel de medische claim - bepaald uiteindelijk de risicoclassificatie. Dit is van belang omdat de notified body uiteindelijk akkoord geeft of de producent een literatuuronderzoek mag uitvoeren of een prospectief clinical trial. Deze beslissing is uiteraard van belang op het te doorlopen tijdspad, waarbij het tijdspad bij enkel een literatuuronderzoek aanzienlijk korter is. Het is verstandig om vooraf al met de (kandidaat) notified body contact op te nemen om ze in een vroeg stadium te betrekken bij het te volgen traject. Dit is niet alleen van belang voor het tijdspad maar ook voor het project budget.

Minder Data, Minder Tijd

Om een CE markering te kunnen en mogen plaatsen moet de producent aantonen dat een medisch hulpmiddel veilig is en presteert zoals beschreven in de handleiding (IFU).

Het presteren van het hulpmiddel kan redelijk snel aangetoond worden, namelijk door bijvoorbeeld een beperkt en niet gerandomiseerd klinisch onderzoek uit te voeren.

Vreemd genoeg vallen deze vereisten in scherp contract met de Amerikaanse klinische vereisten voor veel medische hulpmiddelen waarbij veelal een gerandomiseerd trial de norm is. Zodra de nieuwe 'Medical Device Regulations' (MDR) van kracht is zal deze significante veranderingen met zich meebrengen in het Europese regulatieve landschap. De criteria voor klinische evidentie zullen dan explicieter zijn.

Kortere Tijdslijnen

Gezien het redelijk eenvoudige classificatieproces en de focus op veiligheid en prestaties, kan een CE-markering meestal in een relatief korte tijd verkregen worden. Als de producent een kwaliteitssysteem heeft dat in overeenstemming is met de ISO 13485 en het Technisch Dossier is volledig, dan kan de tijdlijn variëren van twee tot drie - vier maanden vanaf het moment dat de audit uitgevoerd en het dossier ingediend is.

Gebruikmakend van EU data in de US

Als de producent de CE-markering met een kleine klinische trial kan verkrijgen, kunnend verkregen data en gegevens ondersteunend zijn bij de FDA.

De EU-gegevens kunnen vaak als ondersteuning bij een trialopzet worden gebruikt om de steekproefomvang te bepalen. In bepaalde omstandigheden kunnen deze meegenomen worden om te voldoen aan de Amerikaanse eisen. De rol van Europese data en gegevens bij de Amerikaanse aanvraag moet worden beoordeeld door de FDA tijdens een 'pre-submission' bespreking in het IDE-proces.

Wanneer geprobeerd wordt om EU data en gegevens te gebruiken is het van vooraf belangrijk te realiseren of de EU onderzoekssite op een eerder moment door de FDA beoordeeld is geweest bij uitgevoerde studies die bij de FDA zijn ingediend. Je wilt immers niet dat je studie een leerervaring van de site wordt.

Belangrijke Selecties

Selectie van de notified body is een belangrijke beslissing, omdat tussen de producent en de notified body overeenstemming bereikt moet worden met betrekking tot de classificatie en of er een literatuuronderzoek dan wel een prospectieve trial vereist is.

Aanvullend, als de producent geen fysiek kantoor in de EU heeft moet deze een Authorized Representative (AR) aanwijzen.  Deze AR is verantwoordelijk voor productregistraties en vigilantie rapportages. Contactgegevens van de AR dienen op het label en IFU terug te vinden zijn.

Onze dienstverlening omvat o.a.

• Ondersteuning bij product classificatie en hulp bij de identificatie van de juiste standaarden bij een medische hulpmiddel (AIMDD - MDD > MDR; and IVD > IVDR)
• Opstellen en review van het technische product dossier ter verkrijging van de CE markering
• Verificatie van de Essentiele Eisen
• Implementatie, modificatie en onderhoud van het kwaliteitsmanagementsysteem - veelal ISO 13485
• Authorized Representative services in de EU
• Risicomanagement (ISO 14971)
• Opzet van vigilance en post -market surveillance procedure - inclusief 'Post Market Clinical Follow Up' (PMCF)
• QP Services - synoniem voor 'person responsible for regulatory requirements'
• Logistic Management
• Product aansprakelijkheid

 (June 11, 2015)

It is expected that the Final DIS (FDIS.2) of the ISO 13485:201x will be approved during the ISO/TC 210 WG1 meeting scheduled in November 14-20, 2015 (Denver, US). So, final publication of the medical device ISO 13485 scheme will be properly somewhere in Q1/2016.

There’s good and bad news related to the publication. The bad news is that 13485:201x will be published after the ISO 9001:2015 as scheduled in September 2015. One of the aims of ISO TC 210 WG1 was to align ISO 13485 with ISO 9001, which is the baseline for any standard related to quality. The FDIS of the ISO 13485 is not fully aligned yet.

The good news is that the delay gives quality managers time to better prepare for the transition to 13485:201x. The proposed revisions are considerable, and it’s important for medical device companies to start preparing now. Even though the standard will continue to evolve as it moves toward publication, a high percentage of what the DIS currently contains will likely end up in the final version.

Also good news is that publication of the ISO 13485 will be properly at the same time as the publication of the Medical Device Regulations (MDR) and the In Vitro Diagnostic Regulations (IVDR). The impact of the changes of MDR and the IVDR is significant and requires higher investments from manufacturers and other companies to be in compliance with the new EU regulations & requirements.  Companies, in particularly manufacturers, need to anticipate and prepare to deal with proposed changes in a pro-active and timely manner to avoid having CE certificates suspended or revoked. We advise you to be prepared on time!

In summary, there are basically five sections in the draft standard where major changes have been made:

1. Regulatory requirements: The first section establishes an emphasis on regulatory requirements that we see across the rest of the draft standard. This includes not only the local requirements that apply to your facility, but if you are an organization that commercializes its products globally, you also need to take into consideration all relevant international requirements. There are many references to this throughout the draft standard.

1. Risk management: Another theme that permeates the draft standard is the need to incorporate risk management into all the main quality system processes within your organization. Almost everything you do needs to be based on that risk, justifying that what you are doing is adequate and conforms to what you defined as part of your design and production activities.

1. Validation, verification, and design transfer:  The draft standard puts a lot more structure into place surrounding these activities. You must have plans in place and documented evidence to show what you have been doing for validation, verification, and design transfer activities.

1. Outsourced processes and supplier control: The draft standard asks organizations to do a lot more when it comes to outsourcing processes and putting into place controls for assessing your suppliers — again based on risk.

1. Feedback: Finally, the draft requires you to monitor and measure the performance of your quality management system not only during production, but also post-market. You also have to incorporate those activities as part of your risk management process.

1. Interconnection of other requirements. The linkage between all the different clauses within the standard is improved. Everything is more interconnected. Expectation is that you have systems in place that allow you to demonstrate conformity across the requirements in a more streamlined manner. For example, there is not just one section that discusses risk-management or regulatory requirements or CAPA — instead we see these topics addressed throughout the standard. It is a much more integrated approach.

If you would like to maximize your QA / RA services you, please contact  us via This email address is being protected from spambots. You need JavaScript enabled to view it.

On the 19^th of June 2015, the Council agreed the substance of its negotiating stance on two draft regulations aimed at modernizing EU rules on medical devices and in vitro diagnostic medical devices. This is a step towards providing the presidency with a mandate to start talks with the European Parliament with a view to reach an agreement as early as possible.

The two draft regulations on medical devices cover a wide range of products, from sticking plasters to hip replacements, pacemakers and laboratory tests for assessment of medical interventions.  

The main objective of the two draft regulations is to ensure that medical devices are safe. This would be achieved by strengthening the rules on placing devices on the market and tightening surveillance once they are available.  

"We are pleased that under the Latvian presidency major progress could be achieved to strengthen the rules on medical devices. Today's agreement is a decisive step forward to improve patient safety and strengthen European competitiveness. Further work both within the Council and between the Council and the European Parliament is, however, needed to ensure that the benefits of the new rules are put into practice", said Guntis Belēvičs, the Latvian minister for health and President of the Council.  

Placing on the market

Unlike pharmaceuticals, medical devices and in vitro diagnostic medical devices are not subject to pre-market authorization. Instead, they undergo a conformity assessment to establish whether they meet the applicable standards before they are placed on the market. Depending on the risk posed by a product, the assessment may involve a so-called notified body. This is an independent body with specific expertise for certain types of medical devices which assesses whether these medical devices meet the relevant standards.  

The Council further tightened the rules for the designation of notified bodies, for the monitoring of their assessment activities by national competent authorities and for co-operation of those competent authorities. The new rules would also give notified bodies the right and duty to carry out unannounced factory inspections.  

Post-market surveillance 

The Council added explicit provisions on manufacturers' responsibilities for the follow-up of the quality, performance and safety of devices placed on the market.  

More transparency for patients 

The draft regulations seek to provide patients more transparency on the available devices, and increase their traceability.

 Patients who are implanted with a device would be given key information on the product, including any precautions which might need to be taken. Manufacturers of high-risk devices would have to make publicly available a summary of their safety and performance, with key elements of the clinical data. 

Increased traceability 

Manufacturers of medical devices would have to fit their products with a unique device identification to ensure traceability. Manufacturers and importers of both categories of products would have to register themselves and the devices they place on the EU market in a central database. An EU portal would be set up where manufacturers would have to report serious incidents and corrective actions they have taken to reduce the risk of recurrence. The Council took particular care to ensure that the traceability and identification rules can be implemented in practice. 

Next steps 

The agreement on the substance of the Council's negotiating stance will allow the next presidency to take contact with the European Parliament to prepare negotiations between the two institutions. Once the Council has finalized some outstanding technical work concerning the preamble of the two draft regulations, negotiations between the institutions will be able to start. 

• Presidency proposal of 11 June 2015 for a regulation on medical devices
• Presidency proposal of 11 June 2015 for an annex to the regulation on medical devices
• Presidency proposal of 12 June 2015 for a regulation on in vitro diagnostic medical devices
• Presidency proposal of 12 June 2015 for an annex to the regulation on in vitro diagnostic medical devices
• Reform of the EU rules for medical and in vitro devices

(June 10, 2015)

Our analysis of recent published survey - which was initiated by the European Association Medical Device Notified Bodies (TEAM NB) - identified continuous trends towards of: 

• increasing number of certificates being withdrawn; 
• decreasing number of new conformity certificates issued; and 
• increasing number of staff (fte's).

A more in-depth analysis shows statistical significant correlation between 'certificates withdrawn' and 'number of staff NB' .

Analysis of abovementioned identified trends and correlation gives us the following explanations of these features:

• All notified bodies are auditing with stricter enforcement against the EU medical device directives (MDD, AIMDD, IVDD).
• There is a stricter enforcement of various regulatory requirements by National Competent Authorities (CA) and notified bodies, i.e.
• additional requirements on clinical data in the content of clinical evaluation reports;
• requirements relating to planning regarding post-market clinical follow up;
• increased number of unannounced inspections and audits;
• increased control of outsourced processes and supply chain management; 
• increased control of post market.
• Manufactures and stakeholders experiencing increased unexpected costs of product certification caused by i.e.
• total audit days, 
• additional consultancy support, and 
• enhance workload of the QA / RA representative.

These causes may lead to a increased number of non-payment of performed audit  and or delay in payment invoices of NB.

• An limited number of mergers and acquisitions may had influence on identified trend data.
• Discontinuation of business activities due strategic economic decisions by manufacturers and or their investment companies.
• Analysis of internal notified body processes and subsequently 'process improvements' to be in compliance with the new Medical Device Regulations (MDR), In Vitro Diagnostic Regulations (IVDR), and ISO 13485:2016. 
• Outcome of internal notified body training sessions as a significant step in further professionalization of medical device auditors and their staff. 

One cause of all these changes can be found in i.e. the Poly Implant Prostheses (PIP) breast implant scandal what highlighted the consequences of extreme non-compliance. In this particular case the criminal approach of the manufacturer severely impacted the health and wellbeing of many women. It is therefore not surprising that stricter enforcement and additional rules for the market surveillance and the quality and power of inspections/product testing are revisited in the new MDR, IVDR, and the ISO 13485:2016. 

The call for stricter rules to ensure the validity and power of clinical data is not new. The initial intention to promote harmonization of the requirements and approvals of clinical investigations was present in the implementation of the amended EU Directives in 2007 in the laws of the EU member states with due date March 2010.  Nevertheless, there is still considerable inconsistency in the approach and requirements of competent authorities and ethics committees in the different member states. An enhanced degree of regulatory harmonization in the EU to remain an attractive environment for international clinical studies may be an add value in the development process of innovative medical devices. 

Companies, in particularly manufacturers, need to anticipate and prepare to deal with the new situation and with proposed changes in the MDR, IVDR and ISO 13485 in a pro-active and timely manner to avoid having CE certificates suspended or revoked because they were unable to comply with the new regulatory requirements in time. These changes will require significantly higher investment from companies to be and to maintain in compliances of EU regulatory requirements.   

We 're looking forward to support you in implementing all new regulatory requirements in your organization on a sustainable methodology. Our total service concept is build on Training, Project Management Technical File / Quality Management, Communication, and Consultation. We understand that you as medical device company need to be prepared on time to abovementioned changes to protect your assets and to manage your organization in a effectively and efficient way.  The 'classical' role of QA / RA representative will be diminished and a need for professional and integrated support will be helpful.