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‘market surveillance’ means the activities carried out and measures taken by competent authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection;
Mainly MDR Section 3 Market surveillance, Article 101-102, 110, 113
Mainly IVDR Article 6.3., 10.7., 10.8., 10.11, 10.13, 11, 13, 14, 16.4., 20.1., 22.2., 28, 31.6., 36, 42, 47-50, 54, 58.2., 78.4., 80, 81.2-3., 82-97, 102, 110.9., Annex I 20.4.1.(af), Annex III 1. (b), Annex VII 1.1.6. (g), 1.2.6., 1.3.1., 4.5.5., 4.10., Annex IX 5.2., 6, Annex X 3. (k), 5.5., 6., Annex XI 6., Annex XIV 1.7., 1.16., 4.6. and Chapter II 3.
‘health institution’ means an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health;
Mainly MDR Article 5.5., 17.3.-4., 18.2., 25.2. (c), 27.1. (c), 27.9, 121, Annex XIII
‘health institution’ means an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health
Mainly IVDR Article 5.4., 5.5., 22.2(c), 24.1. (c), 24.9., 111
‘importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market;
‘economic operator’ means a manufacturer, an authorised representative, an importer or a distributor;
Mainly IVDR Article 10.11., 13, 14.2.-5., 16, 22, 27-28, 110.8., Annex III 1. (a), Annex VI Part A
‘importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market;
Mainly MDR Article 13, 16, 25, 30,31, Annex VI
‘economic operator’ means a manufacturer, an authorised representative, an importer or a distributor;
‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service;
Mainly IVDR Article 10.11., 13.6., 14, 16, 22, 27.2., Annex III 1. (a)
‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service;
Mainly MDR Article 10.12., 13.6., 14, 16, 25, 30, Annex XIII
‘authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under this Regulation;
‘economic operator’ means a manufacturer, an authorised representative, an importer or a distributor;
Mainly IVDR Article 10.7.-8., 11, 12, 13.2., 13.6-8., 14.2., 14.4-6., 15.6., 22, 27-28, 47.2., 55.1., 85, 90.1., 110. 8., Annex I 20.2. (d), Annex IV 1., Annex VI Part A, Part B 7., Annex VII 1.2.3., 4.3., Annex IX 2.1.-2., Chapter III 2., 6.,7., Annex X 2., 6. 7, Annex XI 6., Annex XII Chapter II 2., Annex XIV 1.2.
‘authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under this Regulation;
Mainly MDR Article 11, Article 12, Article 15(6), Article 25, Article 30, Article 31, Article 60, Article 90, Article 95,.. Annex VI, Annex XIII
‘manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trade mark;
Mainly MDR Article 10, 15, 18, 25, 29, 30, Chapter V, Annex I-VI, Annex VII-XVI
‘manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trade mark;
‘economic operator’ means a manufacturer, an authorised representative, an importer or a distributor;
UK
Switzerland
UK
Switzerland
European database on medical devices (Eudamed)
Mainly IVDR Article 23, 26, 28-30, 113.3. (f)
Medical Device Coordination Group – MDCG
Each Member State shall appoint to the MDCG, for a three-year term which may be renewed, one member and one alternate each with expertise in the field of medical devices, and one member and one alternate with expertise in the field of in vitro diagnostic medical devices.
Mainly MDR Article 103- Article 107
Documents
Meetings (Minutes /Agendas)
Procedural aspects
‘notified body’ means a conformity assessment body designated in accordance with this Regulation;
Mainly MDR Chapter IV, Article 58, Annex VII, Annex XII
‘notified body’ means a conformity assessment body designated in accordance with this Regulation;
Mainly IVDR Article 10.11., 11.6., 11.7., 16.4., 18.5., 26, 28, 29, Chapter IV & V (Articles 31- 55), 78.4., 80-81, 83-84, 87.9., 90, 94-95, 110, Annex IV 8., Annex VI 2., Annex VII, Annex IX-XI, Annex XIV 1.15.,
‘post-market surveillance’ means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;
Mainly MDR Articles 8, 9, 10.9.-10., 15.3, 32.2., 61.9., 83-92, 120.3, Annex I 3., Annex III, Annex VII 4.5.2.-11., Annex IX, Annex XIV
‘Unique Device Identifier’ (‘UDI’) means a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market;
Mainly MDR Article 27, 28, Annex VI
GS1
European database on medical devices – Eudamed
Mainly MDR Articles 26, 28, 29, 30, 33-34, 57, 92, 100, 108
‘clinical evaluation’ means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;
Mainly MDR Chapter VI, Article 54, Annex XIV, Annex XV
It shall apply from 26 May 2021. Derogations in MDR Article 123. 3
Mainly MDR Article 120 and Article 123
Single-use devices – In particular MDR Article 17, Annex I 23.2. (n), 23.4. (p), Annex VI Part C 3.9
Systems & Procedure packs – In particular MDR Article 22, 29.2., Annex VI Part C 3. 7., 6.3.,
Custom-made devices – In particular MDR Article 10.5., 15.1., 21, 52.8., 86.1., Annex I 23.2. (p), 23.3. (g), Annex XIII
Investigational devices – In particular MDR Article 15.3. (e), 21, 52.13., 62.4. (l), 70.7., 71.3., 80, Annex XV
Software – In particular Annex I 14.2., 17, 23.4., Annex II 1.1.j, 6.1., Annex VI Part C, Annex VIII 3.3.-3.4., Mainly Rule 11
Device with a medicinal substance – In particular MDR Article 1.8.-9. 4.4.,54.1.b, 71.3g, 7., 89.6., 117, Annex I 10.3., 12, 23.2., 23.4. s & t, Annex II 6.2., Annex VI, , Annex VIII Rule 6,8,12, 14, 20, Annex IX 5.2.,5.4, 6, Annex XI 8, 16, Annex XIII, Annex XV 1.10, 2.6.
Devices without a medical purpose MDR – In particular Article 1.2.-5., Annex XVI
Implantable devices – In particular MDR Article 10.8., 18, 27.8-9., 32, 52.4-5.& 8., 54.1, 61.4.& 6.& 8.& 11, 86.2., 108, 123.3. (f) (g), Annex I 19., 23.2. (s), 23.4. (f), Annex VI 2.14., 6.1., Annex VIII Rule 8, 9, 15, Annex IX 5.1., 7., Annex X 7., Annex XI 9., 17., Annex XIII 4. , Annex XV 3.15. , Chapter III 3.
‘harmonised standard’ means a European standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012;
Mainly MDR Article 8, 9, 99, Annex II 4.
‘Unique Device Identifier’ (‘UDI’) means a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market;
Mainly IVDR Article 10.6., 10.8.(h), 13.2.(d), 14.2.(d), 24-26, 29.2. (a), 30.2. (b), 55, 84.8., 87, 111, Annex I 20.2. (g), Annex II 1.1., Annex IV 2.3-4., Annex VI, Annex XII Chapter 1
GS1
‘harmonised standard’ means a European standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012;
Mainly IVDR Article 8, 29.2. (d), 67, 99-100, Annex I 20.1.(h), Annex II 4 (c), Annex VII, Annex IX 2.2.-3., Annex X 3., Annex XII, Annex XIII 1.1., 5.2., Annex XIV 2.2, 2.7.
It shall apply from 26 May 2022. Derogation in IVDR Article 113. 3
Mainly IVDR Article 110 and 113
‘CE marking of conformity’ or ‘CE marking’ means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing;
Mainly MDR Article 10.6, 13.2., 14.2.,20, 21-23, 74, Annex V
‘CE marking of conformity’ or ‘CE marking’ means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing;
Mainly IVDR Article 10.5., 18, 19, 70, Annex V
‘post-market surveillance’ means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;
Mainly IVDR Articles 10.8-9., 15.3, 56.6, 78-87, 110.3., Annex I 3., Annex III, Annex XIII
‘common specifications’ (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.
MDR Article 1 and 9
‘common specifications’ (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.
IVDR Article 9
‘performance evaluation’ means an assessment and analysis of data to establish or verify the scientific validity, the analytical and, where applicable, the clinical performance of a device;
Mainly IVDR Articles 56, 78, Annex II 6.2., Annex VII 3.2.4.,4.5. -11., Annex IX, Annex X, Annex XIII
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Meetings (Agenda/Minutes)
Procedural aspects
National implementing Acts
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Text from Judgment in Case C-581/18, PRESS RELEASE No 69/20
… as EU law currently stands, insurance covering the civil liability of manufacturers of medical devices with respect to harm linked to those devices is not the subject of regulation by EU law.
..the Court observed that the patient concerned did not make use of her freedom of movement, since she seeks payment of insurance compensation for harm caused by the insertion of breast implants in Germany, the Member State in which she resides, so that there is no specific connecting factor linking the situation at issue in the main proceedings and that freedom. Second, as regards the freedom to provide services, the Court noted that the situation at issue again has no specific connecting factor linking it to that freedom, since, in the first place, the patient concerned received medical treatment in the Member State where she resides and, in the second place, the insurance contract concerned was concluded between two companies established in one and the same Member State, in this instance France. Last, as regards the free movement of goods, the Court observed that the dispute in the main proceedings relates not to the cross-border movement of goods in itself, since the cross-border movement of the breast implants concerned was not affected by any discriminatory obstacle, but to the harm caused by the goods so moved. Consequently, the situation at issue again has no specific connecting factor linking it to free movement of goods.
First paragraph of Article 18 TFEU must be interpreted as meaning that it is not applicable to a clause, stipulated in a contract concluded between an insurance company and a manufacturer of medical devices, limiting the geographical extent of the insurance coverage against civil liability arising from those devices to harm that has occurred in the territory of a single Member State, since such a situation does not fall, as EU law currently stands, within the scope of application of EU law.
Key words: PIP, Free movement of goods and EU citizens, product liability, defective medical devices, territorial limitations, civil liability insurance coverage
”It was manifestly not the intention of the EU legislature to harmonise the Member States’ legislation regarding insurance against civil liability arising out of the use of medical devices…
The fact that the insurance does not ‘travel’ with the goods, even if it is compulsory in the home Member State for subsequent use of those goods in that Member State, is not an issue that is covered by either Article 34 or Article 35 TFEU (free movement of goods)…
The starting principle for the regulation of the internal market is respect for regulatory diversity in matters not explicitly harmonised by EU law…
It is also for the Member States, as EU law currently stands, to regulate insurance policies applicable to medical devices used on their territory, even when those devices are imported from another Member State. Member States are certainly free, in the absence of harmonisation, to decide to introduce a higher level of protection of patients and users of medical devices through more favourable insurance policies applying on their territory…”
Key Words: product liability, defective medical devices, territorial limitations, insurance regime, EU 2017/745
Text of the Judgments (in French language)
Key Words: access to documents, notified body, commercial interest
”..the terms ‘medicinal product’ and ‘medical device’ are mutually exclusive in such a way that a product that falls within the definition of a ‘medicinal product’ within the meaning of Directive 2001/83 may not be classified as a medical device within the meaning of Directive 93/42 ”
“…the EU legislature intended to reserve the grant of SPCs to medicinal products alone, to the exclusion of both medical devices and substances used as adjuvant products of a medical device.” ”…the extension of the scope of that regulation to such substances would have the practical effect of enabling SPCs covering medical devices which incorporate those substances to be granted. Such a consequence would be contrary to the objective, referred to in recital 10 of Regulation No 469/2009, that the protection granted by an SPC must be strictly confined to the product which obtained MA as a medicinal product. ”
Key words: medicinal product, function, patent, SPC
“Given that the packaging of the medical device concerned has not been modified and the original presentation of the packaging has not been affected other than by the attachment of a small label, which does not conceal the mark and which designates the parallel importer as responsible for placing it on the market by setting out his details, a barcode and a central pharmacological number, it cannot be held that the attachment of such a label constitutes repackaging within the meaning of the judgments Boehringer Ingelheim and Others”
Key words: trademark, parallel import, packaging, label
” …software, of which at least one of the functions makes it possible to use patient-specific data for the purposes, inter alia, of detecting contraindications, drug interactions and excessive doses, is, in respect of that function, a medical device within the meaning of those provisions, even if that software does not act directly in or on the human body..”
“…the EU legislature intended to focus, in order to classify software as a medical device, on the purpose of its use and not the manner in which the effect it is capable of producing on or in the human body is likely to materialise…”
Key words: software, classification, medical devices
“Member States are not required to apply a reduced VAT rate to specific products in Annex III, point 3, to the VAT Directive”
Key words: Principle of fiscal neutrality, VAT, oxygen concentrators
“Under the MDD, no direct responsibility of a notified body for a culpable infringement vis-à-vis the final user, however the civil responsibility (compensation) can be triggered by the national law”
“When there is due cause – in the face of evidence indicating that a medical device may not comply with the legal requirements – the notified body has the obligation to examine such a medical device, the manufacturer’s business records and make unannounced inspections.”
Key words: conformity, liability, notified body, breast implants, Class III
“No need for additional conformity assessment by the parallel importer if a medical device bears a CE marking “
Key words: CE marking, parallel import, Class I
“The production of up to 100 packages of medicinal product for human use per day, carried out in a pharmacy as part of the normal pharmacy business, cannot be considered as manufactured by a method involving an industrial process. Thus, the Directive 2001/83 does not apply.”
Key words: medicinal product, industrial process
“No repackaging or putting device on the market “under his own name”, if the importer only attaches the label and the instructions for use in the official language of the Member State of importation”
“No right of the manufacturer of an diagnostic device to be notified in advance of a parallel import solely because of the fact that that device bears a CE marking.”
“No need for additional conformity assessment by the parallel importer of an medical device bearing a CE marking who translates the labelling and the instructions for use to the official language of another Member State to adapt them to the final user”
Key words: labelling, language, safe-guard clause, in-vitro medical devices, parallel trade
“Corrective colour contact lenses featuring designs are not a cosmetic product, notwithstanding the fact that their outer packaging bears the statement ‘cosmetic eye accessory, subject to the EU Cosmetics Directive’.”
Key words: contact lenses, cosmetics
“If a pacemaker or an implantable cardioverter defibrillator belongs to a group or production series having a potential defect, such a product is classified as defective without the need to establish that the product has a defect.”
“For a defective pacemaker, the damage covers the costs related to the replacement of such a defective product, for which the producer is liable.”
“For an implantable cardioverter defibrillator, it is for the national court to decide whether the deactivation of the magnetic switch is sufficient for the purpose of overcoming the defect in that product.”
Key words: defective product, replacement, pacemaker, implantable cardioverter defibrillator
“Indications to determine a medical purpose of a product: Use intended by the manufacturer and treatment carried out in an authorised medical centre and under the supervision of a practitioner.”
“The dimensions, weight and technology used are not decisive factors for the classification of goods”
Key words: goods, nomenclature, classification, intended purpose, medical purpose
“It is for national courts to verify the legality of prohibition decisions on placing a medical device on the market taken by the national authorities in this connection.”
“Alleging that the Commission should, of its own initiative, have commenced a safeguard clause procedure in relation to the effecto device – it must firstly be held- that this is a misinterpretation of the division of powers between the Commission and the Member States.”
Key words: health, conformity, omission, safeguard procedure
Remark: Under the new Regulation, so called “safeguard clause procedure” is governed by Article 95.
“A product bearing a CE marking can be a medical device in one Member State and qualified as a medicinal product in another – on the basis of its pharmacological, immunological or metabolic action.”
Key words: classification, medicinal product
Remark: Under the new Regulation, Article 4 (Regulatory status of products) prescribes that the Commission shall – after consulting the Medical Device Coordination Group – by means of implementing acts determine whether or not a specific product is a medical device. In addition, the Commission has the obligation to ensure the sharing of expertise among the Member States in order to determine the appropriate regulatory status of a product.
“Exclusive personal use v.general use devices”
“Annex III to the Directive 2006/112 does not authorise a reduced rate of VAT to be applied to medical devices which, viewed objectively, can be used only to prevent, diagnose, treat, alleviate or cure human or animal illnesses or ailments, but which are not intended for the exclusive personal use of the disabled.”
Key words: reduced VAT, personal use
“Medical use is inherent to the medical devices.”
“The concept of a ‘medical device’ covers an object conceived by its manufacturer to be used for human beings for the purpose of investigation of a physiological process only if it is intended for a medical purpose.”
Key words: medical purpose, medical use
“The products with pharmacological action classified as a medicinal product: as well as the pharmacological, immunological or metabolic properties of the product in question, which constitute the factor on the basis of which it must be ascertained whether it may be used in or administered to human beings with a view to restoring, correcting or modifying physiological functions, account must be taken, in determining whether a product falls within the definition of a medicinal product ‘by function’ for the purposes of that provision, of all the characteristics of the product, including, inter alia, its composition, the manner in which it is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail.”
Key words: demarcation, cosmetics, pharmacological action
“General prohibition to sell contact lenses via the Internet is not proportionate to the objective of ensuring the protection of public health under the EU law.”
“E-commerce directive applies to certain aspects of selling contact lenses online- except rules related to the supply of those products.”
Key words: e-commerce, general ban, contact lenses
“Medical devices bearing the CE marking are considered to meet the essential requirements referred to in Article 3 of the Directive.”
“National legislation under which the commercial exportation of dental amalgams containing mercury and bearing the CE marking is prohibited on grounds relating to protection of the environment and of health is not compatible with the EU law.”
Key words: CE marking, protection of environment, protection of health
Infringement on the side of Greece for the administrative practice of consistent and general nature of directly rejecting public supply contract of medical devices fulfilling the requirements of the European Pharmacopoeia technical standard.”
Key words:public tender, hospital supplies
“A product cannot be regarded as a medicinal product where, having regard to its composition – including its content in active substances – and if used as intended, it is incapable of appreciably restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action.”
Key words: medicinal product, demarcation
“In order to assess the similarity of goods or services, all the relevant features of the relationship which could exist between them should be taken into account. Those factors include, in particular, their nature, their intended purpose, their method of use and whether they are in competition with each other or are complementary.” “As regards the material for stopping teeth and dental wax, they are in competition with the medical devices covered by the earlier mark and are complementary to the surgical and medical apparatus also protected by the earlier mark.”
“The global assessment of the likelihood of confusion, as far as concerns the visual, aural or conceptual similarity of the marks in question, must be based on the overall impression given by the marks, bearing in mind, in particular, their distinctive and dominant components.
Key words: trade mark, similarity
Public tendering for devices that must comply with the European Pharmacopoeia and bear the CE marking: 1. “The principle of equal treatment and the obligation of transparency preclude a contracting authority from rejecting, directly on grounds of public health and without following first the safeguard procedure, if the devices comply with the stated technical requirement.” 2. “The contracting authority needs to suspend such a tendering procedure. However, the authority is entitled to take all interim measures required to enable it to procure the materials necessary for the smooth running of that hospital.”
“Once those devices comply with the harmonised standards and are certified in accordance with the procedures provided for by that directive, they must be presumed to comply with those essential requirements and therefore be deemed to be appropriate for the use for which they are intended. In addition, these medical devices must benefit from free movement within the Union.”
“The presumption of compliance of medical devices can, however, be rebutted.”
Key words: public tender, CE marking, compliance, technical inadequacy, safeguard procedure, public health
“The obligation to state the registration number on the external packaging and to mention that registration on the notice accompanying each medical reagent is not proportionate with EU law.”
Key words: packaging, registration, reagent
Commission Regulation (EU) No 722/2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin
Commission Regulation (EU) No 207/2012 on electronic instructions for use of medical devices
IV. Old EU law on medical devices applicable to some medical devices covered by valid Directive-certificates until April 2025 (end of transition period), see Article 120(3) and (4), Article 122 of the Regulation on Medical Devices
Reclassification of hip, knee and shoulder joint replacements:
Directive 2005/50/EC – OJ L 210/41 of 12.08.2005
Reclassification of breast implants:
Directive 2003/12/EC – OJ L 28/43 of 04.02.2003
Notified Bodies and their audits
Commission Implementing Regulation (EU) No 920/2013 – OJ L 523 of 25.09.2013
Commission Recommendation of 24 September 2013 – OJ L 253/27 of 25.09.2013
Electronic instructions for use of medical devices
Commission Regulation (EU) No 207/2012 – OJ L72 of 10.03.2012
Medical devices manufactured utilising tissues of animal origin:
Variant Creutzfeld-Jakob Disease assays:
Commission Directive 2011/100/EU – OJ L341/50 of 22.12.2011
Common Technical Specification on IVD:
Eudamed – European Databank on Medical Devices:
This section contains EU law which is not specific to medical devices, but which might be applicable to some medical devices. Please note that:
– further regulations and directives than those listed here might be applicable;
– no definitive statement on the applicability or non-applicability can be made here.
The question of applicability of law to medical devices is particularly tricky. A definitive clarification covering all cases cannot be provided by this or any other website.
All statements refer to the relationship between the Regulation on Medical Devices and other EU law, unless explicit reference is made to the Directive on Medical Devices. The result would mostly, but not always identical for the relationship between the Directive on Medical Devices and other EU law.
The results may also partly differ for the Regulation on In vitro diagnostic Medical Devices.
Directive 85/374/EEC on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products
Consumer products
Directive 2001/95/EC on general product safety (see this Guidance)
Directive 2011/83/EU on consumer rights
Devices put into service on distance by internet or other electronic services
Directive 2000/31/EC on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market
Devices using energy
Legislation on energy efficiency and energy labelling, see this Overview
Devices which are machinery
Annex I to Directive 2006/42/EC on machinery is applicable via references from Medical Devices Regulation and Medical Devices Directive. The fulfilment of the requirements of this Annex I is examined in the medical devices conformity assessment procedure; other parts of the Machinery Directive do not apply.
Devices which are also measuring and weighing instruments
Directive 2014/32/EU on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments
Devices referring to measurement units
Directive 80/181/EEC on the approximation of the laws of the Member States relating to units of measurement
Devices problematic under aspects of occupational safety
Various directives could apply. See OSHA-page for overview; and in particular the following:
Devices emitting electromagnetic fields
Directive 2013/35/EU on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields)
Radio emitting devices
Directive 2014/53/EU on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment
Low voltage devices covered by Annex XVI of the Regulation on Medical Devices (as from the entry into application of respective Common Specifications); but not devices with a medical purpose
Directive 2014/35/EU on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits
For EU law on waste and in particular electronic and electric waste, see here; see also the navigation bar on the left of the page, linking to further legislation on waste.
Electric / electronic devices with hazardous substances
Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment
Devices using particular chemicals
REACH (see also further links on this site)
Classification, labelling, packaging of chemicals (see also further links on this site)
Devices using radioactive substances
Directive 2013/59/Euratom laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation
Legislation on human medicines (applicable via reference from Medical Devices Regulation and Medical Devices Directive)
Legislation on human tissues (applicable via reference from Medical Devices Regulation and Medical Devices Directive)
Directive 2004/10/EC on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances
References to this Directive are e.g. contained in the law on medicines, see above.
Regulation (EU) 2016/425 on personal protective equipment – the legislator has intended that either this Regulation or medical devices law applies
Regulation (EU) 1223/2009 on cosmetic products – the legislator has intended that either this Regulation or medical devices law applies
Regulation (EC) No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety – the legislator has intended that either this Regulation or medical devices law applies
Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products – see Article 2(2)(b) of that Regulation
Directive 2014/30/EU on the harmonisation of the laws of the Member States relating to electromagnetic compatibility – see Article 2(3) of this Directive and Article 1(11) of the Regulation on Medical Devices
applicable to some medical devices until April 2025 (end of transition period); partly also applicable to new law:
Commission Regulation (EU) No 722/2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin
Commission Regulation (EU) No 207/2012 on electronic instructions for use of medical devices
IV. Old EU law on medical devices applicable to some medical devices covered by valid Directive-certificates until April 2025 (end of transition period), see Article 120(3) and (4), Article 122 of the Regulation on Medical Devices
Reclassification of hip, knee and shoulder joint replacements:
Directive 2005/50/EC – OJ L 210/41 of 12.08.2005
Reclassification of breast implants:
Directive 2003/12/EC – OJ L 28/43 of 04.02.2003
Notified Bodies and their audits
Commission Implementing Regulation (EU) No 920/2013 – OJ L 523 of 25.09.2013
Commission Recommendation of 24 September 2013 – OJ L 253/27 of 25.09.2013
Electronic instructions for use of medical devices
Commission Regulation (EU) No 207/2012 – OJ L72 of 10.03.2012
Medical devices manufactured utilising tissues of animal origin:
Variant Creutzfeld-Jakob Disease assays:
Commission Directive 2011/100/EU – OJ L341/50 of 22.12.2011
Common Technical Specification on IVD:
Eudamed – European Databank on Medical Devices:
This section contains EU law which is not specific to medical devices, but which might be applicable to some medical devices. Please note that:
– further regulations and directives than those listed here might be applicable;
– no definitive statement on the applicability or non-applicability can be made here.
The question of applicability of law to medical devices is particularly tricky. A definitive clarification covering all cases cannot be provided by this or any other website.
All statements refer to the relationship between the Regulation on Medical Devices and other EU law, unless explicit reference is made to the Directive on Medical Devices. The result would mostly, but not always identical for the relationship between the Directive on Medical Devices and other EU law.
The results may also partly differ for the Regulation on In vitro diagnostic Medical Devices.
Directive 85/374/EEC on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products
Consumer products
Directive 2001/95/EC on general product safety (see this Guidance)
Directive 2011/83/EU on consumer rights
Devices put into service on distance by internet or other electronic services
Directive 2000/31/EC on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market
Devices using energy
Legislation on energy efficiency and energy labelling, see this Overview
Devices which are machinery
Annex I to Directive 2006/42/EC on machinery is applicable via references from Medical Devices Regulation and Medical Devices Directive. The fulfilment of the requirements of this Annex I is examined in the medical devices conformity assessment procedure; other parts of the Machinery Directive do not apply.
Devices which are also measuring and weighing instruments
Directive 2014/32/EU on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments
Devices referring to measurement units
Directive 80/181/EEC on the approximation of the laws of the Member States relating to units of measurement
Devices problematic under aspects of occupational safety
Various directives could apply. See OSHA-page for overview; and in particular the following:
Devices emitting electromagnetic fields
Directive 2013/35/EU on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields)
Radio emitting devices
Directive 2014/53/EU on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment
Low voltage devices covered by Annex XVI of the Regulation on Medical Devices (as from the entry into application of respective Common Specifications); but not devices with a medical purpose
Directive 2014/35/EU on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits
For EU law on waste and in particular electronic and electric waste, see here; see also the navigation bar on the left of the page, linking to further legislation on waste.
Electric / electronic devices with hazardous substances
Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment
Devices using particular chemicals
REACH (see also further links on this site)
Classification, labelling, packaging of chemicals (see also further links on this site)
Devices using radioactive substances
Directive 2013/59/Euratom laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation
Legislation on human medicines (applicable via reference from Medical Devices Regulation and Medical Devices Directive)
Legislation on human tissues (applicable via reference from Medical Devices Regulation and Medical Devices Directive)
Directive 2004/10/EC on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances
References to this Directive are e.g. contained in the law on medicines, see above.
Regulation (EU) 2016/425 on personal protective equipment – the legislator has intended that either this Regulation or medical devices law applies
Regulation (EU) 1223/2009 on cosmetic products – the legislator has intended that either this Regulation or medical devices law applies
Regulation (EC) No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety – the legislator has intended that either this Regulation or medical devices law applies
Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products – see Article 2(2)(b) of that Regulation
Directive 2014/30/EU on the harmonisation of the laws of the Member States relating to electromagnetic compatibility – see Article 2(3) of this Directive and Article 1(11) of the Regulation on Medical Devices
applicable to some medical devices until April 2025 (end of transition period); partly also applicable to new law:
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