The Clinical Trial Regulation will come into operation in 2018 and replace the existing EU Clinical Trial Directive (EC) No. 2001/20/EC. This regulation will change the way clinical trials are conducted in the European Union (EU) by harmonizing the assessment and supervision processes for clinical trials throughout the EU via an EU portal and database which will be maintained by the European Medicines Agency (EMA) in collaboration with the Member States and the European Commission. EMA will make information stored in the database publicly available subject to transparency rules. Read more
The New Clinical Trial Regulation & Its Benefits
Obelis attends GLAM Consortium Meeting
Obelis Chief Compliance Officer, Mrs. Sandra Ferretti, and Senior Regulatory Expert, Mrs. Louise Olliver, attended GLAM consortium meeting, which took place between 18th and 19th May 2017. GLAM is a European Union funded project for development of innovative In-vitro diagnostic devices. The meeting was held at Novellic – Belgrade, one of the consortium partners, who in charge of manufacturing the prototype of the laser multiplex device detecting various cancers, all in one testing procedure, as well as serving as companion device. Read more
It is official: New EU MDR & IVDR enter into force
On 5th May 2017, the new EU Medical Devices and In-Vitro Diagnostics Devices Regulations have been finally published in the Official Journal of the European Union. This means that the new Regulations will officially enter into force 20 days after their publication (hence on 25th May 2017) and replace currently existing directives MDD 93/42/EEC, AIMD 90/385/EEC and IVDD 98/79/EC. Read more
New Medical Devices & IVD Regulations adopted by the European Parliament
On 5th April 2017 the European Parliament published an official press release announcing that New Medical Devices and In-Vitro Diagnostics Devices Regulations have been finally adopted. This vote is the final step in the long-lasting process to update existing MDD & IVD legislations, which started in the 90s. Final texts of new Regulations are expected to be published in the Official Journal in May 2017.
Obelis at Medica 2016
Obelis Group exhibited for the 13th consecutive year at Medica Trade Fair, one of the biggest medical industry fairs in the world. The exhibition took place in Messe Dusseldorf (Germany) between 14th and 17th December 2016. Obelis’ team, comprised of 13 experts, offered free EU Compliance Consultancy sessions, ran an EROMED seminar and met with Obelis clients. Read more
Obelis to hold EROMED seminar at MEDICA 2016
Obelis Group will hold an EROMED seminar at the MEDICA trade show, taking place from the 14th November till 17th November in Messe Düsseldorf, in Germany. The seminar, which is entirely free of charge, will be conducted at the Obelis booth (Hall 17, Stand D59), every day at 11 am and 3 pm. It will focus on the new proposal on EU legislation on Medical Devices and its impact on the compliance path and the CE marking process. Read more
Obelis Attends Inauguration of CURAM (Center for Research in Medical Devices)
Obelis Chief Compliance Officer, Mrs. Sandra Ferretti, participated in the official inauguration of CURAM – Center for Research in Medical Devices, which took place on Monday, the 26th of September 2016 in Galway, Ireland. The event, co-organised by Dr James J. Browne, the President of NUI Galway and Professor Abhay Pandit, the director of CURAM, brought together world-class academic, medical devices industry and clinical partners. Read more
MEDDEV 2.7/1 – new guidelines on clinical evaluations
On the 29th of June 2016, the European Commission released a new version of MEDDEV 2.7/1, entitled “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directive 93/42/EEC and 90/382/EEC”. The recently issued file replaces the 2009 version. It outlines clear guidelines for both manufacturers and Notified Bodies on how to conduct a clinical evaluation of medical devices. Read more
EU to release NEW Medical Device Regulations!
In June 2016, the European Parliament released the consolidated texts of the new EU Regulation Proposals on Medical Devices and In-Vitro Diagnostics Devices. The texts, published on the European Parliament website, reflect the position agreed by the European Parliament and the Council of the European Union.
New Medical Devices and In-Vitro Diagnostic Regulations – Status of the Ongoing Discussions
Obelis Launches a Bulgarian National Registration Service
In accordance with the Law on Medical Devices, adopted by the Bulgarian Parliament during its session on June 12, 2007, and as promulgated in the Bulgarian State Gazette No. 46, some categories of medical devices must be registered with the Bulgarian Drug Agency (BDA). This registration is mandatory for medical devices that enter the EU internal market through, or if they are being manufactured in, the territory of Bulgaria.
Common Approach on the Medical Devices Legislative Package
On October 5, 2015, the Ministers of the EU countries agreed, after almost three years of discussions, on a general approach on the medical devices legislative package. This agreement is a major step towards ratification of new regulations on medical devices and in vitro medical devices that would ensure a higher level of health and safety protection for EU citizens as end users of these devices.
Obelis Launches the Croatian National Registration Service
New List of MDD Harmonized Standards Published by the European Commission
Commission Opinion on Prohibiting the Use of Permanent Dermal Fillers for Aesthetic Purposes
On July 11, 2014, the Dutch authorities notified the European Commission of the draft decree amending the Medical Devices Decree (Besluit Medische Hulpmiddelen), which aims to prohibit the use of permanent dermal fillers for anything other than reconstructive purposes.
Electronic File Submission to the Belgian Agency for Medicines and Health Products
Notification files for Class I Medical Devices, kits and procedure packs can currently be submitted in an electronic format to the Belgian Federal Agency for Medicines and Health Products (FAMHP).
The completion of the Notification procedure constitutes a prior condition to ensure the compliancy of Medical devices with the essential requirements of the MDD Directive; and therefore is a necessary step in order to affix the CE marking and sell the devices freely within the EU Market. Read more
Reference countries for FREE SALES CERTIFICATE
A Free Sales Certificate (FSC) also referred to as “Free Trade Certificate” or “Certificate for Export” is an international export document. The certificate is intended to serve as evidence that the goods (medical devices, cosmetics, pharmaceuticals, etc.) meet the health and safety requirements of the exporting market and can therefore be made available on the importing market. Read more
Final Opinion on the Safety of Medical Devices containing DEHP (phthalate)
After months of public consultation, The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has now published the final Opinion on the safety of medical devices containing DEHP-plasticized PVC or other plasticizers on neonates and other groups that are possibly at risk. Read more
IMDRF proposes QMS Principles for Software as a Medical Device
In April 2015, the International Medical Device Regulators Forum (IMDRF) released a new guidance document on the application of Quality Management Systems (QMS) for software as a Medical Device (SaMD). Public consultation was open until 2015 June and final document is supposed to be published in October 2015. Read more
EU Council agrees on a General Approach for Medical Devices and IVDs Regulations
On 19 June 2015 the Council of the European Union reached a general consensus on two draft Regulations aimed at modernising EU rules on Medical devices and In vitro Diagnostic Medical Devices. These new Regulations, once adopted, will replace the current MDD 93/42/EEC and IVDD 98/79/EC directives. Read more
Europe moves forward on New and Emerging Technologies
New EU Rules on Human Tissues and Cells
On April 8th 2015 the European Commission adopted new rules aimed at ensuring high standards of quality and patient safety regarding human cells and tissues distributed in the European Union. Read more
European Court of Justice to Clarify Liability for Medical Device
Germany’s Federal Supreme Court is currently seeking clarity from the Court of Justice of the European Union (CJEU) on the liability and responsibilities of Notified Bodies under the Medical Devices Directive 93/42/EEC. On 9th April 2015 the German court decided to refer a liability case involving a breast implant dispute to the CJEU and has asked the CJEU to provide clarification on the interpretation of Notified Body liability for medical devices in the EU. Read more
European Parliament Rejects the Inclusion of Health in the TTIP Talks
On April 14th 2015 Members of the Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) approved an Opinion on recommendations to the European Commission on the negotiations for the Transatlantic Trade and Investment Partnership (TTIP). They voted in favour of the exclusion of five health-related topics from the TTIP negotiations between the EU and the United States. Read more
European Commission adds New Exemptions to RoHS Directive
On April 10th 2015, two new EU Restriction of Hazardous Substances exemptions were published in the Official Journal of the EU.
These two new exemptions, along with the expiration dates, are applicable to “Medical devices” and “Monitoring and control instruments including industrial monitoring and control instruments” category 8 and 9 of the Annex IV to RoHS Directive 2011/65/EU.
Are you aware of what substances and until when their usage was exempted? Check it out below!
Results of the mHealth in Europe Consultation
On the 12th January 2015, the European Commission published the results of the consultation on the Green Paper on mobile health. Public Authorities, healthcare providers, patients’ organisations and web entrepreneurs, inside and outside the EU, gave feedback on eleven issues related to the uptake of mobile Health (mHealth) in the EU. Read more
European Court of Justice introduces Product Batch Liability
EU Medical Devices Legislation – An Update
Reform of the Medical Device regulatory framework, where are we?
Published for the first time in 2012, the EU Commission’s proposal is stuck as EU Member States cannot agree on key point of the file. Read more
Early Implementation of an EU Vigilance Portal
Transatlantic Trade and Investment Partnership: Steps towards faster access to Medical Devices
According to recent reports, it appears clear that the future Transatlantic Trade and Investment Partnership (TTIP) between the European Union and the United States will most likely entail a higher level of reciprocal recognition and an easier circulation of Medical Devices between the two sides of the Atlantic.
Following the conclusion of the 6th and 7th rounds of negotiations, held respectively in July 2014 and October 2014, it seems clear that both, the European Union and the United States are eager to work towards recognising each other’s procedures for the approval and control of Medical Devices and to improve their cooperation in this area.
NEW list of harmonized standards for medical devices
The European Commission has published the new list of European standards relating to medical devices.
On 16th of January 2015 The European Commission published a number of Communications providing an updated list of harmonized standards in the framework of the following Council Directives:
- Medical Devices Directive 93/42/EEC
- In-vitro Diagnostic Medical Devices 98/79/EC
- Active Implantable Medical Devices 90/385/EEC
Progress on upcoming regulations on Medical Devices
On December 1st 2014 The European Council took note of the progress report of the Italian presidency on the two proposals for new regulations on medical devices and in vitro diagnostic medical devices.
The report noted that considerable progress has been achieved on these files under the Italian presidency. However, further discussions are needed for the Council to agree its position.
European Commission investigates the safety of Metal-on-Metal hip implants
The European Commission asked the Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) for a scientific opinion to assess the safety of Metal-on-Metal (MoM) joint replacements with a particular focus on hip implants. The final opinion has been adopted on September 24th 2014.
The opinion aims to assess whether there are any health concerns linked to the use of MoM implants in arthroplasty. It also seeks, where possible, to provide indications on design of the devices, on patient groups and to identify needs for further research.
New IEC 60601-1-2: 4th Edition for Medical Electrical Equipment
In February 2014, the International Electrotechnical Commision introduced the 4th edition of IEC 6061-1-2:2014 for medical electrical equipment. The fourth edition of this harmonized standard cancels and replaces the third edition of IEC 60601-1-2, published in 2005, and implies the significant technical revisions such as new risk analysis and immunity requirements.
The new edition may have a dramatical impact to the medical industry and presents several challenges relating to the design, EMC testing and documentation to the medical devices.
So what are the new changes? And how this new edition will affect your business? Here we look at the recent 4th Edition and its effect on the EMC Compliancefor medical devices.
NEW Revision to ISO 13485:201x postponed to 1Q 2016
The publication of the next version of ISO 13485 is postponed to 2016. Welcome ISO 13485:2016!
During the last meeting of the Technical Committee Working Group held in July, the published draft version of ISO 13485 was submitted to the vote of the Working Group members. The draft was not approved.
There will be a new round of comments / changes / approval, which makes the objective of publishing the final version in 2015 very unlikely. Read more
New version of the Blue Guide 2014. What is new?
In April 2014, the European Commission finally published the revised Blue Guide on the implementation of EU products rules (The “Blue Guide”). This updated version of the Blue Guide reflects the modernization and harmonization of the EU legislative framework for marketing of products.
The Concept and Objectives of the revision
The New Blue Guide updates the previous edition of the Blue Guide (Guide to the implementation of the directives based on the New Approach and the Global Approach), published in 2000. Since then, as it is stated in the new Blue Guide, it has become one of the main reference documents explaining how to implement the legislation based on the New Approach, now covered by the so-called New Legislative Framework (NLF). Read more
New EU Rapporteur for the Medical Devices Revision Package
On September the 17th 2014, the European Parliament appointed Glenis Wilmott – UK member of the Labor Party – as new rapporteur for the ongoing revision of the Medical Devices Legislation.
Mrs. Willmott will be responsible for guiding the new rules through the European Parliament as well as negotiating with the Commission and national governments within the Council. Read more
New package of measures for marketing of products
EU Commission revises 700 Old Approach directives and 27 New approach Directives
The Package of measures known as the “New legislative framework” was published in the Official Journal on 13 August 2008. The measures are designed to help the internal market for goods work better and to strengthen and modernize the conditions for placing a wide range of industrial products on the EU market.
The target of the New Legislative Framework is:
- Improve market surveillance rules to better protect consumers and professionals from unsafe products
- Boost the quality of the conformity assessment of products
- Clarify the meaning of CE marking
- Define roles of economic operators
New version of the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices
To facilitate the interpretation of the Directive on Medical Devices 93/42/EEC with regard to classification and borderline medical devices, a Medical Devices Expert Group chaired by the European Commission was established in order to prepare a guidance manual on this matter. The development of this manual has also been triggered by the need for a common approach within the EU and amongst stakeholders.
Should Original Equipment Manufacturers obtain CE Marking?
Obelis, a Regulatory Partner for Horizon 2020 projects
Obelis is honored to announce its participation in the largest European project for Research and Innovation run by the European Commission – Horizon 2020. This, in continuous to Obelis’ activities under the FP7 program.
What is Horizon 2020?
Horizon 2020 represents the largest European project for Research and Innovation with a budget of almost 80 Billion euros. The program, available for 7 years (2014-2020) is a financial instrument used by the European Commission order to ensure global competitiveness across the entire European Market.
Being an extension of the earlier FP7 (7th Framework Program for Research and Technological Development), Horizon 2020 aims, as well, at increasing the number of jobs and at maintaining leadership in the global knowledge economy, but more than that, it promises a more market oriented approach, by taking innovative ideas from the lab to the market.
The Horizon 2020 program would normally include the following process:
- Proposal Submission
- Allocation of Partners
- Experts Evaluation
- Grant Agreement
What is Obelis Role?
Obelis partners with different project leaders, all across the European Union towards supporting their projects with advice and consultancies on the correct regulatory and compliance process with EU legislation.
Obelis role in such projects would normally focus on the following objectives:
- Setting up the project technical documentations, towards compliance with the essential requirements of the applicable EC legislations.
- Preparing the project towards Certification (CE Marking & EN/ISO 13485);
Providing CE Marking advisory services on medical devices for over 25 years, allowed Obelis to not only support the medical device industry at product launch but also at the initial stages of design and development.
Being a continuous supporter of the single market, Obelis has also been a strong promoter of the EU Research and Innovation programs. As with previous research projects, Obelis aims to continue providing regulatory advice to Horizon 2020 projects, yet to come.
If you would like to know more on the Horizon 2020 program, please do not hesitate to contact us.
Irish Authorities restructure
On July 1st 2014, the Irish national regulator for medicines, medical devices, cosmetics and other health products will be named HPRA (Health Products Regulatory Authority) instead of its former name – IMB (Irish Medicines Board)
According to the HPRA, the new name more clearly reflects the wider scope of functions and responsibilities assigned to the regulatory authority in reference to its initial status established in 1996, towards regulating only human & veterinary medicines.
As such, the HPRA is officially responsible to regulate the following range of sectors on the Irish market, including: cosmetics, medical devices, controlled drugs, clinical investigations and more.
Principle activities of HPRA towards Cosmetics
Under the competencies/services of the HPRA:
- Operating an effective and broad reaching market surveillance program
- Investigation of safety concerns arising during cosmetic product use.
- Inspection of manufacturers and distributors of cosmetic products.
- Participation in international activities, including relevant EU working groups.
- Generation of Certificates of Free Sale.
How will HPRA monitor Cosmetics?
Under its market surveillance activities, the HPRA shall conduct annual programs for products being sampled for analytical testing and review. HPRA market surveillance activities will focus on products which were reported to lead to serious undesirable effects (SUEs) or products reported through the EU rapid alert network (RAPEX) to all EU Member states.
Cooperation with Responsible Persons
The HPRA will work closely with Responsible Persons towards the key requirements of which may include but are not limited to:
- Product information file (PIF)
- Good Manufacturing Practices (GMP)
- Communication of serious undesirable effects
- Sampling, analysis and Traceability within the supply chainCorrective actions in the event of cosmetic product non-compliance
The HPRA will work closely with Responsible Persons towards corrective and/or preventative measures to ensure consumer safety – such as:
- A change in usage instructions;
- Updates to product labeling;
- Additional precautions for use;
- Product recall or withdrawal;
The HPRA will continue to operate under the regulatory framework of the European Cosmetic Regulation EC 1223/2009 towards enforcing it by monitoring the safety and compliance of cosmetic products. The HPRA will rely on effective and pro-active post market surveillance activities which will focus on sampling and analysis alongside a close work with Responsible Persons.
If you would like to know more on the Irish Health Products Regulatory Authority, please contact us.
More Supervision on Notified Bodies by NEW 920/2013 Regulation
On September 24th 2013, The European Commission has published the Implementing Regulation 920/2013 on the designation and the supervision of Notified Bodies that sets more stringent requirements for the designation and surveillance of Notified Bodies (NB).
The new measures were adopted as a part of the European Commission Joint Plan for Immediate Action, whose aim is to restore confidence in the Medical Devices sector following the Poly Implant Prothèse breast implant scandal.
What’s new in the regulation:
The Regulation consists of 10 Articles and 2 annexes.
The main novelties of this legislation are focused on the:
- Introduction of a joint assessment procedure for the designation of Notified Bodies (EU bodies accredited to certify theCE marking), involving experts from the European Commission and from the designating authorities of other Member States. Moreover, the designation of NB becomes limited in time and needs to be regularly renewed.
- Clarification of the essential knowledge and experience requirements for the staff of the NB.
- Obligation to conduct regular monitoring and surveillance of NB in order to ensure that they are constantly compliant with the relevant Organizational and General Requirements identified in Annex II of the Implementing Regulation.
- Possibility to perform unannounced on-site audits of NB.
- Exchange of experience between designating authorities on relevant questions concerning the interpretation of provisions of Directive 90/385/EEC and Directive 93/42/EEC.
- Enhanced cooperation between the European Commission and National Competent Authorities (the Assessment Reports shall be made available, upon request, to all other Member States).
Impact on the Authorized Representative
The Implementing Regulation 920/2013 reaffirms the distinction of roles between Notified Bodies and Authorized Representatives:
Article 1.3 of Annex I (on the Interpretation of criteria set out in Annex 8 to Directive 90/385/EEC and in Annex XI to Directive 93/42/EEC) explicitly states that “Conformity assessment body, its top management and the personnel responsible for carrying out the conformity assessment tasks shall not offer or provide or have offered or provided, during the last three years, consultancy services to the manufacturer, his authorized representative, a supplier or a commercial competitor”.
The new Regulation, therefore acknowledges the role of the European Authorized Representative as provider of consultancy services and regulatory updates to MD manufacturers.
Expectations for the future implementation
The implementation of the provisions contained in Regulation 920/2013 will ensure a better supervision of Notified Bodies and of their activities and an improved flow of information between the competent authorities and Notified Bodies both at national and EU level.
If you would like to know more on the new Regulation on the Designation and Supervision of Notified Bodies, please contact us
Italy Decree on online registration of IVDs!
On June 5th 2014, Italy enacted the Ministerial Decree of 23 December 2013 – requiring all manufacturers of In-Vitro Diagnostics Medical Devices, intending to place their devices on the Italian market, to have their devices registered on the Italian Ministry of health on-line database.
The NEW Decree was enacted towards improving market surveillance and traceability as well as improving the monitoring of public hospitals and other public sanitary structures.
Does the NEW RoHS 2011/65/EC Directive Apply to Medical Devices?
The recast of the Restriction of Hazardous Substances (RoHS) Directive was published in the official journal of the European Commission on the 8th of June 2011 as 2011/65/EU.
With the exception of the items listed in Article 2.4, the RoHS Directive applies to all Electrical & Electronic Equipment.
Medical devices (under 93/42/EEC) and IVD devices (per 98/79/EC) are now included. They are both part of the general group called ‘medical devices’ in the directive. Active implantable medical devices (under AIMDD 90/385/EEC) remain excluded from the scope of the 2011/65/EU.
The maximum concentrations in homogenous materials are limited, by weight, to the following:
Lead (0.1 %)
Mercury (0.1 %)
Cadmium (0.01 %)
Hexavalent chromium (0.1 %)
Polybrominated biphenyls (PBB) (0.1 %)
Polybrominated diphenyl ethers (PBDE) (0.1 %)
Devices must bear a CE marking and have a declaration of conformity for the RoHS Directive from:
- 22nd of July 2014 for Medical Devices.
- 22nd of July 2016 for In-Vitro Diagnostic Medical Devices.
NOTE: A single CE marking and declaration are acceptable. (You will need to explain the dual meaning of the CE marking in the instructions for use and clarify that, if used, the Notified Body number only applies to the MDD or IVDD related issues.)
- Means any natural or legal person established within the European Union who has received a written mandate from a manufacturer to act on their behalf in relation to specified tasks (RoHS 2011/65/EU Article 2.7);
- A Non-EU manufacturer (not having a registered address in the EU) will be required to nominate an Authorized Representative in order to obtain the CE marking.
- Cables and spare parts needed for the repair or reuse of devices may continue to be distributed for devices placed on the market prior to the transition date.
- Exemptions available to all devices are listed in Annex III. Specific exemptions for medical devices are listed in Annex IV.
- Exemptions for medical devices will be valid for up to 7 years.
- Requests for exemptions:
- Must be filed with the Commission and include all information listed in Annex V. Most notably, the request must include an analysis of possible alternative substances, materials or designs.
- Renewals must be requested at least 18 months before the existing exemption expires.
The labeling requirements are likely to have been already addressed by MDD or IVDD requirements. However, a review of the requirements in Articles 7.g, 7.h9.d and 10.a will be needed for confirmation.
- Records must be retained for 10 years after a device is placed on the market. Note that this may be longer than required by the MDD 93/42/EEC or IVDD 98/79/EC.
- Records to retain include technical documentation confirming compliance with the RoHS Directive and a register of non-conforming products and product recalls.
Regulatory updates on the standard EN 980
The European Commission (EC) has published on January 24th, 2013, the list of EU Harmonized standards applicable to medical devices. It appears that two harmonized standards have gone missing: EN 980 and EN ISO 15223-1 are not on the list. Those standards are very important for medical devices manufacturers, as their goal is to harmonize the rules regarding symbols used on labels (in addition to the language requirements).
The Commission explained that the disappearance of EN 980 was a mistake: EN ISO 15223-1 was supposed to be harmonized and to eventually replace EN 980 all together. However, the Commission decided otherwise, as the EN ISO 15223-1 seemed not to provide an overall standard to the three medical devices directives – MDD 93/42/EEC, AIMDD 90/385/EEC & IVDD 98/79/EC).
Public workshop by EC on NEW medical device regulations
The NEW proposals for regulations for medical devices and in-vitro diagnostics medical devices, adopted by the European Commission last September (proposal 2012.541 & proposal 2012.542) were discussed at a public workshop held by the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI), on February 26th 2013.
These NEW proposals are intended to replace the current MDD 93/42/EEC, AIMDD 90/385/EEC & IVDD 98/79/EC and to be adopted and accepted by the EU Parliament & the Council of European Union is (under most cases) under an Ordinary Legislative Procedure (OLP).
Obelis’ notification officers, in charge of the pre-market notification of medical devices & in-vitro diagnostic medical devices as European Authorized Representative Center (OEARC) of such Non-EU manufacturers, participated to this workshop to provide a summary of the main topics presented:
Ireland EU Presidency, to influence Medical Device Regulations
On January 1st 2013, Ireland took over the presidency of the Council of the European Union under the presidency trio of 2013-2014 (Ireland, Lithuania & Greece). Ireland presidency will be between, January 1st 2013 till June 30th 2013. This will be the 7th time Ireland holds this office and it coincides with the 40th anniversary of Ireland joining the European Union (1973).
What is the Code of Conduct for Notified Bodies?
How and whether to Audit Authorized Representatives?
TEAM-NB is the European Association of Notified Bodies for Medical devices. It is a non-profit organization which its members are Notified Bodies (EU bodies accredited to certify for CE Marking). It has published on November 7th 2012, a position paper titled “How and whether to audit Authorized Representatives”?