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
Industry News In-Vitro Diagnosis
EU Council agrees on a General Approach for Medical Devices and IVDs Regulations
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 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
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.
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).
Impact on the Authorized Representative by NEW medical device proposals
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
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
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
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
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
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.
NEW WEEE Directive’s Affects on Medical Devices
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
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
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?
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).
Animal by-products EU regulation on Medical and Cosmetic products
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
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.
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