News

European Commission adds New Exemptions to RoHS Directive

in News

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!

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Results of the mHealth in Europe Consultation

in News

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

in News

On March 5th 2015 the Court of Justice of the European Union published its Decision in In Joined Cases C‑503/13 and C‑504/13, concerning pacemakers and Implantable Cardioverter Defibrillators.

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EU Medical Devices Legislation – An Update

in Industry News Medical Devices, News

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

in Industry News Medical Devices, News

The Medicines and Healthcare Products Regulatory Agency (MHRA) regulates medicines and medical devices in the UK. Together with other National Authorities, they started a pilot project on the implementation of an EU vigilance reporting portal for medical devices. Read more


Transatlantic Trade and Investment Partnership: Steps towards faster access to Medical Devices

in Industry News Medical Devices, News

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.

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NEW list of harmonized standards for medical devices

in Industry News Medical Devices, News

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:

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Progress on upcoming regulations on Medical Devices

in Industry News Medical Devices, News

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.

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European Commission investigates the safety of Metal-on-Metal hip implants

in Industry News Active Implantable Medical Devices, News

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.

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New IEC 60601-1-2: 4th Edition for Medical Electrical Equipment

in Industry News Medical Devices, News

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.

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NEW Revision to ISO 13485:201x postponed to 1Q 2016

in News

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 Industry News Active Implantable Medical Devices, Industry News In-Vitro Diagnosis, Industry News Medical Devices, News

img_news_bluguideIn 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

in Industry News Medical Devices, News

Which expectations?

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

in Industry News Active Implantable Medical Devices, Industry News In-Vitro Diagnosis, Industry News Medical Devices, News

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

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New version of the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices

in Industry News Medical Devices, News

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.

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Should Original Equipment Manufacturers obtain CE Marking?

in Medical Device Compliance - FAQs, News

Obtaining the CE Marking provides a great strategic advantage for any manufacturer! This is true whether you are an Original Equipment Manufacturer (OEM) or an Original Brand Labeler (OBL).

Conclusion:
If you are an OEM manufacturer, obtain your own CE Marking today!

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Obelis, a Regulatory Partner for Horizon 2020 projects

in Industry News Active Implantable Medical Devices, News

Obelis is honored to announce its participation in the largest European project for Research and Innovation run by the European CommissionHorizon 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);

Future Expectations

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

in Industry News Active Implantable Medical Devices, News

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)

Img_news_Irish Authorities restructure

VisitHPRA’s Website

Why now?

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:

  • Labeling
  • Notification
  • 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;
  • Re-formulation;
  • Product recall or withdrawal;

Future Expectations

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

in Industry News Active Implantable Medical Devices, Industry News In-Vitro Diagnosis, Industry News Medical Devices, News

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!

in Industry News In-Vitro Diagnosis, News

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.

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Does the NEW RoHS 2011/65/EC Directive Apply to Medical Devices?

in Industry News Active Implantable Medical Devices, Industry News Medical Devices, Medical Device Compliance - FAQs, News

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.

Scope:

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.

Limits: 

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 %)

Transition: 

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.)

Authorized Representative:

  • 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.

 

Exemptions:

  • 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.

 

Labeling:

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.

Record Retention:

  • 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

in Industry News Active Implantable Medical Devices, Industry News In-Vitro Diagnosis, Industry News Medical Devices, News

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).

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Public workshop by EC on NEW medical device regulations

in Industry News Active Implantable Medical Devices, Industry News In-Vitro Diagnosis, Industry News Medical Devices, News

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:

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Ireland EU Presidency, to influence Medical Device Regulations

in Industry News Active Implantable Medical Devices, Industry News In-Vitro Diagnosis, Industry News Medical Devices, News

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).

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What is the Code of Conduct for Notified Bodies?

in Medical Device Compliance - FAQs, News

TEAM-NB is the European Association of Notified Bodies for Medical devices. It is a non-profit organization in which the members are Notified Bodies (EU bodies accredited to certify for CE marking). It has recently published the version 3.0 of the code of conduct for Notified Bodies.

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How and whether to Audit Authorized Representatives?

in Editorial - Position Papers, News, Publications

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”?

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What is the best way of selecting a Notified Body?

in Medical Device Compliance - FAQs, News, Publications

Notified Bodies are organizations accredited by national EU competent authorities with the aim of supporting the manufacturer by carrying out conformity assessment procedures and issuing conformity certificates, thus supporting the manufacturer to affix the CE marking to their medical devices. Such conformity procedures and certificates are required under the “New Approach” Directives for medical devices – MDD 93/42/EEC, AIMDD 90/385/EEC and IVDD 98/79/EC.

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Are disinfectant products classified as medical devices?

in Medical Device Compliance - FAQs, News

When considering the characteristics of a disinfectant product for the purpose of product classification, manufacturers may conclude that their products fall within the scope of a medical device or an accessory to a medical device.

The MDD 93/42/EEC, Annex IX, rule 15 dictates:
– All devices intended specifically to be used for disinfecting medical devices are in Class IIa. ►M5 Unless they are specifically to be used for disinfecting invasive devices, in which case they are in Class IIb.

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Promotion & advertising rules for Medical Devices by EU Directives

in Industry News Medical Devices, News

At many occasions, medical device professionals are faced with uncertainty and confusion when initiating promotions of medical devices. This is due to the fact that EU legislation provides little guidance and direct rules on the promotion or sampling of medical devices within the European Market

The common mistake is the assumption that such matters are not regulated – the assumption is of course erroneous as the promotion of medical devices is governed by several EU Directives, most of which are of general application, as well as the EU member states national laws implementing such Directives. Ultimately, the real challenge resides in the identification of the applicable provisions and their implementation to the specific cases.

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Impact on the Authorized Representative by NEW medical device proposals

in Industry News Active Implantable Medical Devices, Industry News In-Vitro Diagnosis, Industry News Medical Devices, News

The new proposal on medical devices and the new proposal on in-vitro diagnostics medical devices as presented during the press conference of September 26th 2012, by the EU Commissioner for Health and Consumer Policy, John Dalli bring important changes to the role & responsibilities of the authorized representative.

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Obelis officially welcomes NEW Proposals of European Medical Device Legislation

in Industry News Active Implantable Medical Devices, Industry News In-Vitro Diagnosis, Industry News Medical Devices, News

Obelis European Authorized Representative Center (O.E.A.R.C.), 24 years in business and operating as one of the largest regulatory centers in Europe today, providing CE marking advisory services and European Authorized Representative services – officially welcomes the new proposals for new regulations on medical devices and in-vitro diagnostics medical devices as presented during the press conference, by the EU Commissioner for Health and Consumer Policy, John Dalli.

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Review of Press Conference on NEW Proposals of European Medical Device Legislation

in Industry News Active Implantable Medical Devices, Industry News In-Vitro Diagnosis, Industry News Medical Devices, News

With over 500,000 medical devices on the European market and the recent PIP fraud incident, amending the current European legal frame work on medical devices was inevitable;

On the 26th of September 2012, Mr. John Dalli, EU Commissioner for Health and Consumer Policy, presented in a 25 minute press conference of September 26th 2012, the main principles within the proposals for new regulations for medical devices and in-vitro diagnostics medical devices adopted by the European Commission.

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Eucomed welcoming medical device proposals with reservations

in Industry News Active Implantable Medical Devices, Industry News In-Vitro Diagnosis, Industry News Medical Devices, News

Eucomed, the European medical technology industry association has expressed its welcome to the adoption of the proposals for new regulations for medical devices and in-vitro diagnostics medical devices by the European Commission.

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Update on Medical Device Regulations in Switzerland

in Industry News Active Implantable Medical Devices, Industry News In-Vitro Diagnosis, Industry News Medical Devices, News

The European Economic Area (EEA) is formed by the 27 member states of the European Union as well as the 3 EFTA countries, Iceland, Norway & Lichtenstein (view map of the EEA ) – as such, one can wonder, what is the status of Switzerland within this league of nations and how medical devices are regulated in this market?

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Commission Proposal for a NEW REGULATION on Medical Devices and In-Vitro Diagnostic Medical Devices

in Industry News Active Implantable Medical Devices, Industry News In-Vitro Diagnosis, Industry News Medical Devices, News

On 26th Sept, 2012 the Commission has adopted a Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and a Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on in vitro diagnostic medical devices as announced during the press conference by John DALLI, Member of the EC in charge of Health and Consumer Policy.


The EU Regulation 722/2012 on utilizing tissues of animal origin

in Industry News Active Implantable Medical Devices, Industry News Medical Devices, News

The EU Regulation 722/2012 on AIMDD 90/385/EEC and MDD 93/42/EEC utilizing tissues of animal origin was published in the Official Journal L212 on 09 August 2012, entered into force on the 28 August 2012 and applicable from 29 August 2013. As a regulation, it does not need to be transposed into national legislations by the individual EU states.

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NEW WEEE Directive’s Affects on Medical Devices

in Industry News Active Implantable Medical Devices, Industry News In-Vitro Diagnosis, Industry News Medical Devices, News

How does WEEE apply to Medical Devices?

As opposed to the WEEE Directive 2002/96/EC & 2003/108/EC, which states that Medical Devices (regulated under MDD 93/42/EEC, IVD 98/79/EC, AIMDD 90/385/EEC falling under WEEE do not require achieving any recycling collecting target, the repealing WEEE Directive 2012/19/EU tightens the legislation and sets tangible objectives:

  • From 13th August 2012: Medical Devices are subjects to a recovery target of 70% and a recycling target of 50%;
  • From 15th August 2015: Medical Devices are subjects to recovery target of 75% and a recycling target of 55% respectively;
  • From 15th August 2015: Medical Devices (falling under category 4: Large equipments) are subjects to recovery target of 85% and a recycling target of 80% respectively; and Medical Devices (falling under category 5: Small equipments) are subjects to recovery target o 75% and a recycling target of 55% respectively;

The above indicated objectives make all Medical Device manufacturers, distributors, vendors and consumers take the necessary steps, if necessary, to fulfill the new WEEE requirements.

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New WEEE Directive 2012/19/EU (Waste of Electric & Electronic Equipments) is published

in News

What is the objective?

The utmost aims of the WEEE Directive are to reduce the amount of waste electrical and electronic equipment that piles up in landfills and to enhance a more efficient environmental protection. The Official Journal of the European Parliament has published the NEW WEEE Directive 2012/19/EU on 24 July 2012; nearly ten years after the first WEEE Directive 2002/96/EC & 2003/108/EC

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Post Marketing Surveillance on Medical Devices – US FDA Working Groups

in News

Two public meetings were organized by the United States Food & Drug Administration (FDA) on post market Surveillance System and the good use of registries in post market.

The 1st meeting was held on September 10th, 2012 with the purpose to solicit public feedback regarding FDA’s proposal to strengthen the national medical device post market surveillance system.

The 2nd meeting took place on the 12th and 13th September 2012. The purpose of this meeting was to discuss best practices for use of registries with medical device data for post market surveillance, clinical studies, and evidence appraisal.

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New lists of harmonized standards for medical devices published by EU Commission

in Industry News Active Implantable Medical Devices, Industry News In-Vitro Diagnosis, Industry News Medical Devices, News

On August 30th 2012, The EU Commission released 3 new lists of EU Harmonized Standards for medical devices under the Medical Device Directives (MDD 93/42/EEC, IVD 98/79/EC, AIMDD 90/385/EEC).

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Cyprus took over EU Presidency – The role of the EC Rep

in News

The role of the rotating Presidency of the Council of the European Union is, from time to time, not perfectly clear even for a European Member State not even mentioning a non-EU country, to whom it may appear as a function without any effects.

The reality is, however, the contrary. The Presidency’s role and activity during the 6 months can have a significant impact on both EU and non-EU members.

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Revision of the IEC 60601-1 Regarding Medical Devices, 3rd Edition

in Industry News Active Implantable Medical Devices, Industry News In-Vitro Diagnosis, Industry News Medical Devices, News

The International ICE 60601-1 standard and its 3rd revision regarding the safety and effectiveness of medical electrical equipment are of crucial importance to the manufacturers of such medical devices. More so since the 3rd revision will come into force starting the 1st of June 2012.

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Medical Devices in Distribution Channel Complying with IEC 60601-1, 3rd edition?

in Industry News Active Implantable Medical Devices, Industry News In-Vitro Diagnosis, Industry News Medical Devices, News

Manufacturers incorporating electric components to medical devices may find a dilemma when addressing the conformity to the 3rd edition of the IEC 60601-1, in reference to medical devices already on the distribution channel or such devices about to be shipped out of the factory. What does the standard mean? What do you have to do as manufacturers of medical devices and systems to still be able to distribute your products on the European Market come June 2012 (when the 3rd edition of IEC 60601-1 shall be fully applicable).

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New Electronic Labeling for Medical Devices

in Industry News Active Implantable Medical Devices, Industry News Medical Devices, News

A new Regulation (EU 207/2012) on electronic instructions for use of medical devices has been recently adopted by the European Commission and it will come into full force starting 1st of Marc 2013.

Apart from the CE marking affix requirements and the designation of a European Authorized Representative (EAR) for all non-EU manufactures of medical devices underlined by the MDD 93/42/EEC and AIMDD 90/385/EEC, the new Regulations brings several instructions for manufacturers on how to make available the electronic labels of products.

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New Agency for Medical Device Registration in France

in Industry News Active Implantable Medical Devices, Industry News Medical Devices, News

On April 29th 2012, France published in its official journal about the creation of a new agency, the National Agency for the Safety of Medicines and Health Products (MSNA), aimed to replace entirely its current regulatory agency, Afssaps, within a few months.

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Registration TAX on Medical Devices Cancelled by Italian MoH

in Industry News Medical Devices, News

Since 2007, all classes of medical devices to be sold on the Italian territory are to be registered with the Italian Ministry of Health Database allowing them access to the public and private sectors (Class I devices are exempt unless required to be sold to the public sector, in which case, they must be registered as well).

As of January 24th, 2012, a new rule was introduced, waiving the required 100 Euros Registration Tax on medical devices registered in Italy. This was mainly due to the increase of 5.5% of the fee for promotional expenses. This new law came into force upon its publication in the Gazzetta Ufficiale, on the 23rd of March, 2012.

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Medical Devices Workshop in Sao Paulo by EG Mont & Obelis

in News

With a collaboration of over a decade, OBELIS and its Representative in Brazil, EG MONT, are proud to launch a resourceful workshop on the 23rd of May, 2012 in Sao Paulo.

As a special support to manufacturers exhibiting or visiting Hospitalar 2012 the Workshop will cover current issues and processes on the implementation of EU directives, EU harmonized standards and detailed steps to be taken by manufacturers in order to attain the CE marking affixed on their medical devices.

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European Parliament Issued a Resolution on PIP

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The PIP resolution (Poly Implant Prothese, the French company that manufactured substandard breast implants) which was proposed by The Environment and Public Health (ENVI) Committee of the European Parliament was recently adopted with a unanimous vote.

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Obelis Obtains ISO 13485:2003 Certification

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In addition to the ISO 9001:2008 certificate obtained since May 2001, Obelis European Authorized Representatives Center (O.E.A.R.C.) has obtained its ISO 13485:2003 certification in April 2012, attesting to the high level of quality services provided to its clients.

ISO 13485:2003 sets prerequisites for quality management systems, evidence to a company’s capacity to manufacturer medical devices and/or provide related services aimed at consistently meeting customer and regulatory requirements.

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New MEDDEV 2.12-1/rev7 on Vigilance Systems published

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The new MEDDEV 2.12-1/rev7 Guidance document released in March 2012 has updated the requirements related to the European system for the notification and evaluation of incidents and field safety corrective actions (FSCA) involving medical devices. The revised guidance will be applicable as of June 15th 2012.

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