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
Industry News Medical Devices
Final Opinion on the Safety of Medical Devices containing DEHP (phthalate)
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
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
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
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
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.
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 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
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
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
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.
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
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).
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:
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).
Promotion & advertising rules for Medical Devices by EU Directives
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.
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.
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.
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.
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.
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?
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
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.
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.
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).
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.
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).
New Electronic Labeling for Medical Devices
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.
New Agency for Medical Device Registration in France
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.
Registration TAX on Medical Devices Cancelled by Italian MoH
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.
Animal by-products EU regulation on Medical and Cosmetic products
in Industry News Active Implantable Medical Devices, Industry News In-Vitro Diagnosis, Industry News Medical Devices, News, Publications
Regulation EC 1069/2009 and its implementing Commission Regulation 142/2011 – in effect as of 4th March, 2011 – lay down the public and animal health rules for animal-by-products (ABPs) and derived products to prevent and minimize risks to health deriving from these products.
By definition: ‘animal by-product’ means entire bodies or parts of animals, products of animal origin or other products obtained from animals, which are not intended for human consumption (Article 3). These include: fallen stock on farms, wild animals when they suspected of being diseases, slaughterhouse waste, skins, feathers, blood, or meat, fish, milk and eggs when they are interned for human consumption. (Article 8, 9, 10);
Due to the increasing number of incidents, when serious diseases (TSE, BSE, swine fever) started to spread in a consequence of the lack of risk control, the preceding Regulation (EC 1774/2002) has been thoroughly revised. As a result, the current Regulation:
- Gives a more comprehensive scope and more apparent framework to the Regulation;
- Defines animal-by-products in a more transparent way;
- Clarifies the products exempted from the control of this Regulation;
- Improved the categorization of ABPs in line with risks:
- Category 1 material (e.g. animals killed in the context of TSE eradication measures)
- Category 2 material (e.g. manure, non-mineralized guano and digestive tract content)
- Category 3 material (e.g. carcasses and parts of animals slaughtered)
Consequently, the Regulation provides a greater overall legal certainty for the given substance. It has an impact on any person or business using, disposing, storing, handling or transposing animal-by-products.
Applicability for Medical Devices, In-vitro diagnostic medical devices & Cosmetics
One the most significant change that the Regulation introduces is the concept of end point in the manufacturing of animal by-products, beyond which the processed products are no longer subject to the requirements of the Regulation, due to the eliminated potential risks via heat or chemical substances. (Article 5 /Rec.22). Consequently, certain finished products such as cosmetics, medical devices and in vitro diagnostic kits are excluded from the scope of Regulation 1069/2009 in this way to reduce operational burdens, e.g. labeling or record-keeping.
The following derived products may be placed on the European market, regulated by certain Community legislation other than that of Regulation 1069/2009 (see Article 33):
- Cosmetic products as defined in Article 1(1) of Directive 76/768/EEC – See Compliance Page;
- Active implantable medical devices as defined in Article 1(2)(c) of Directive 90/385/EEC – See Compliance Page;
- Medical devices as defined in Article 1(2)(a) of Directive 93/42/EEC – See Compliance Page;
- In-vitro diagnostic medical devices as defined in Article 1(2)(b) of Directive 98/79/EC – See Compliance Page;
According to Article 34 importing, collecting animal-by-products for manufacturing the above mentioned devices, their respective Directives should be taken into account. Should not these Directives provide steps to control potential risks deriving from animal-by-products then Regulation 1069/2009 shall be applicable. However, intermediate products intended for the manufacture of medical products, veterinary medicinal products, medical device, active implement medical devices, in vitro diagnostic medical devices or laboratory reagent are subject to the obligations imposed by Regulation in question.
To conclude the above, Regulation 1069/2009 and Commission Regulation 142/2011 does not apply to finished products under the respective scopes of the:
- Scope of MDD 93/42/EEC
- Scope of AIMDD 90/385/EEC
- Scope of IVDD 98/79/EC
- Scope of Cosmetics under the 76/768/EEC and repealing regulation EC 1223/2009,
Since they are not considered as ‘animal by-products not intended for human consumption’. Therefore; they are not subjected to any veterinary checks under Council Directive 97/78/EC that lays down the principles governing the organization of veterinary checks on products entering the Community from third countries.
EU Regulation on Animal by-products affects Medical Devices & Cosmetics
in Industry News Active Implantable Medical Devices, Industry News In-Vitro Diagnosis, Industry News Medical Devices, News
Regulation 1069/2009 and Commission Regulation 142/2011 does not apply to finished products under the respective scopes of the:
- Scope of MDD 93/42/EEC
- Scope of AIMDD 90/385/EEC
- Scope of IVDD 98/79/EC
- Scope of Cosmetics under the 76/768/EEC and repealing regulation EC 1223/2009,
Since they are not considered as “animal by-products not intended for human consumption”. Therefore; they are not subjected to any veterinary checks under Council Directive 97/78/EC that lays down the principles governing the organization of veterinary checks on products entering the Community from third countries.
To review the complete analysis under our publication page – Click here;
Italy Registration Update: Class I Medical Devices
Background
According to Italy’s Decree of Feb. 20, 2007, all classes of medical devices introduced in Italy after May 1, 2007 must be registered in the Italian Ministry of Health Database. It has been confirmed by the Italian Ministry of Health that manufacturers of Class I Medical Devices with an EC Rep established outside of Italy are not obligated to complete such registration.
CRITICAL Update
While this may seem to be an improvement to the current system for Class I manufacturers, it is not necessarily in their best interest. If a manufacturer decides not to register its Class I device, the device is only authorized to be sold in the private sector, thus drastically reducing market potential and sales. With Class I registration, devices may be sold to both the public and private sectors.
Commission Decision on the European Databank on Medical Devices
Commission Decision of 19 April 2010 on the European Databank on Medical Devices.
Articles 5 and 6 – Competent Authorities will have just under 2 years (until 30 April 2012) to enter information on manufacturers, ARs and devices for all medical devices currently on the market and those going on until 1st May 2011.
New Guidance on classification has been published
The NEW Guidance Document (MEDDEV) on the classification of Medical Devices has been published by the European Commission, DG HEALTH AND CONSUMER Directorate B , Unit B2 “Cosmetics and medical devices”.
Legal Challenges at time of Non-Renewal of a CE certificate
By Dr. Peter N. Ruys – Senior Regulatory Expert for Obelis s.a.
In order to place a medical device on the European Market a manufacturer needs to be in conformity with the applicable European regulation. In this case in compliance with the Medical Device Directive.
One of the requirements for upper Class devices (Class IIa, IIb or III) is to obtain a CE certificate issued by a European Notified Body – the CE certificate has a time and activity related validity. Based upon his certificate the manufacturer is allowed to place medical devices in the European market.
What happens if the CE certificate is NOT renewed?
1. Is the manufacturer allowed to place NEW devices on the market?
2. What about the existing devices already on the market? Should the manufacturer recall his devices? What are the manufacturer’s responsibilities?
3. Can the manufacturer change his claim and therefore affix the CE marking based on another Directive?
Obelis Senior Regulatory Expert, Dr. Peter Ruys provides his view on these important questions;
New Portuguese National Law Transposing the 2007/47/EC announced
The Portuguese Health Products Directorate (Infarmed – Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.) announced this week that the new national Decree-Law 145/2009 transposing the European Directives for medical devices (Dir 93/42/CEE and 90/385/CEE) came into force as of March 21st 2010.
Medical Devices to Comply with the PPE 89/686/EEC
By the 2007/47/EC which came into full force as of March 21st 2010, face masks may have to comply from with the essential safety requirements of the MDD 93/42/EEC as Class I medical devices AND also with the essential safety requirements of the PPE 89/686/EEC.
