Regulated Sectors · Sub-area
Healthcare, Pharma and Food Lawyers in Spain
AEMPS, EMA, AESAN, EFSA. Medicine authorisations, MDR (EU) 2017/745 and IVDR (EU) 2017/746 certification with a 2025-2028 recertification calendar, food labelling, and defence in the health regulator's sanctioning proceedings.
The legal framework for the healthcare, pharmaceutical and food sector
The healthcare and food sector is one of the most heavily regulated under European law. For medicines, Directive 2001/83/EC — transposed in Spain by Law 29/2006 — establishes the marketing authorisation regime through the AEMPS or, for centralised procedures, the EMA (European Medicines Agency).
For medical devices, the European Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) have replaced the former MDD and IVDD directives, imposing substantially stricter certification, technical documentation, post-market surveillance and traceability requirements. Regulation (EU) 2023/607 set the final transition deadlines for manufacturers holding certificates under the previous regime.
For food, Regulation (EU) 1169/2011 governs food labelling, and Regulation (EC) 178/2002 sets out the principles of European food law and the RASFF rapid alert system. AESAN (the Spanish Food Safety and Nutrition Agency) is the control body in Spain, coordinating with the EFSA (European Food Safety Authority) at European level.
| Rule | Matter regulated |
|---|---|
| Reg. (EU) 2017/745 (MDR) | Medical Devices Regulation — replaces the MDD Directive 93/42/EEC. Classifies medical devices into classes I, IIa, IIb and III. Requires a Notified Body certificate for classes IIa-III. |
| Reg. (EU) 2017/746 (IVDR) | In Vitro Diagnostic Medical Devices Regulation — replaces the IVDD Directive 98/79/EC. Reclassifies IVDs into classes A, B, C and D with stricter requirements for classes C and D. |
| Reg. (EU) 2023/607 | Amends the MDR and IVDR Regulations, extending the transition periods for devices with valid MDD/IVDD certificates. Sets the final 2025-2028 deadlines. |
| Directive 2001/83/EC | Community code on medicinal products for human use. The basis for European marketing authorisations and the centralised procedure before the EMA. |
| Law 29/2006 | Guarantees and Rational Use of Medicines and Medical Devices Act — transposes Directive 2001/83/EC. Regulates AEMPS authorisations, advertising and the sanctioning regime in Spain. |
| Reg. (EU) 1169/2011 | Food information provided to consumers — mandatory labelling, allergen declaration, nutritional declaration. Applies to all operators marketing food in the EU. |
| Reg. (EC) 178/2002 | General principles and requirements of food law. Establishes the EFSA (European Food Safety Authority) and the RASFF rapid alert system. |
| Law 17/2011 | Food Safety and Nutrition Act — regulates AESAN, official control plans, food alerts and the food sanctioning regime in Spain. |
Reg. (EU) 2023/607 · Final deadlines
MDR and IVDR recertification calendar 2025-2028
The transition deadlines set by Regulation (EU) 2023/607 are binding. Once they expire, devices without CE marking under the MDR or IVDR cannot be placed on the EU market.
| Regulation | Device class | Examples | Deadline |
|---|---|---|---|
| IVDR | Class D (high risk) | Class D IVDs: diagnosis of serious transmissible diseases, ABO/Rhesus blood grouping. | 31 Dec 2025(expired) |
| IVDR | Class C | Class C IVDs: diagnosis of infectious diseases, tumour markers, self-testing. | 31 Dec 2026← urgent |
| IVDR | Class B and sterile Class A | Class B IVDs: general-purpose reagents. Sterile Class A: culture media and similar. | 31 Dec 2027 |
| MDR | Implantable Class III and implantable Class IIb | Highest-risk medical devices: active implants, stents, hip prostheses, pacemakers. | 31 Dec 2027 |
| MDR | Class IIa, non-implantable Class IIb, Class Is/Im/Ir | Medium-high risk devices: contact lenses, infusion pumps, measuring devices. | 31 Dec 2028 |
Source: Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards transitional provisions for certain medical devices and in vitro diagnostic medical devices.
Healthcare, pharma and food services
Six areas of advice
Legal coverage across the six disciplines with the greatest regulatory impact for pharmaceutical laboratories, medical device manufacturers and food operators operating in Spain and the European market.
Medicine authorisation
Processing marketing authorisations before the AEMPS through the national procedure, and before the EMA through the centralised, decentralised or mutual recognition procedure. Amendments, renewals and withdrawals of marketing authorisations. Defence against authorisation refusals or revocations.
MDR certification — medical devices
Regulatory advice on the certification process under Regulation (EU) 2017/745 (MDR): device classification, selecting a Notified Body, preparing technical documentation, clinical evaluation, EU declaration of conformity and CE marking. Managing transition deadlines (Reg. 2023/607).
IVDR certification — in vitro diagnostics
Certification under Regulation (EU) 2017/746 (IVDR): reclassifying IVDs under the new A/B/C/D system, gap audits against the former IVDD, selecting a Notified Body for classes B-D, performance studies and technical documentation. Urgent management of class C (Dec 2026) and D (Dec 2025) deadlines.
Defence before the AEMPS
Representation in AEMPS sanctioning proceedings for breaches of Law 29/2006 or the MDR/IVDR Regulations: authorisation defects, unlawful advertising of medicines, breach of pharmacovigilance obligations, safety alerts or market withdrawal. Administrative appeal before the Ministry of Health and judicial review before the National Court.
Food labelling and advertising
Compliance with Regulation (EU) 1169/2011: label audits, allergen declaration (Annex II), nutritional declaration, health and nutrition claims (Reg. 1924/2006), food advertising (AESAN). Novel Foods (Reg. 2015/2283): authorisation of new foods. Adapting labelling to new formats and markets.
Food safety and AESAN penalties
Defence in inspections and sanctioning proceedings before AESAN and regional public health authorities: breach of HACCP plans, hygiene rule infringements (Reg. 852/2004), market withdrawals and RASFF alerts. Preventive advice on food safety management systems (ISO 22000, IFS, BRC).
European dimension
Coordination with the EMA and EFSA
EMA — European Medicines Agency
The EMA evaluates and supervises medicines for human and veterinary use in the European Union. The centralised procedure before the EMA is mandatory for biotechnological, oncology, rare-disease and new-therapy medicines. Opinions from the EMA's Committee for Medicinal Products for Human Use (CHMP) are binding on all Member States. Representation before the EMA and coordination with the CHMP during evaluation or post-authorisation stages require specialised legal-regulatory advice.
EFSA — European Food Safety Authority
The EFSA is the European Union's leading scientific body on food safety. It issues scientific opinions underpinning the European Commission's regulatory decisions on additives, flavourings, enzymes, novel foods, genetically modified organisms (GMOs) and pesticides. Submitting novel food authorisation applications to the European Commission requires preparing technical dossiers subject to EFSA assessment.
Law 29/2006 · Law 17/2011
The healthcare and food sanctioning regime
The healthcare and food sectors have their own sanctioning regimes, with differentiated fine amounts and the possibility of ancillary measures such as market withdrawal, seizure and closure of the establishment.
Medicines and medical devices — Law 29/2006
| Type | Fine amount | Limitation period | Examples of infringements |
|---|---|---|---|
| Very serious | Up to €1,000,000 | 5 years | Marketing without authorisation, counterfeiting medicines, non-compliance with an ordered withdrawal, misleading advertising of prescription medicines. |
| Serious | Up to €100,000 | 3 years | Breach of authorisation conditions, pharmacovigilance deficiencies, marketing with incomplete labelling, unauthorised advertising. |
| Minor | Up to €30,000 | 1 year | Formal documentation defects, minor breaches of reporting obligations to the AEMPS. |
Food safety — Law 17/2011
| Type | Fine amount | Limitation period | Examples of infringements |
|---|---|---|---|
| Very serious | Up to €600,000 | 5 years | Marketing food that endangers health, concealing food alerts, repeated food fraud. |
| Serious | Up to €60,000 | 3 years | Breach of HACCP plans, misleading labelling, failure to report a food alert, obstructing inspection. |
| Minor | Up to €3,000 | 1 year | Formal labelling defects, minor hygiene breaches, delays in reporting to AESAN. |
In addition to fines, the AEMPS, AESAN and regional authorities can order the withdrawal of affected products from the market, seizure, temporary or permanent closure of the establishment, and publication of the penalty. Decisions can be appealed before the competent Ministry and, through judicial review, before the National Court.
Our value proposition
Why sector companies trust Dobarro
Regulator know-how
Experience in proceedings before the AEMPS, AESAN and regional public health authorities. We know the criteria applied in healthcare and food sanctioning proceedings, and the arguments that work at the administrative stage and on judicial review.
Urgent defence against market withdrawals
Market withdrawals and safety alerts demand an immediate response. Dobarro acts from the first hours: reviewing communications with the AEMPS or AESAN, analysing the scope of the interim measure, arguing for its revocation or limitation, and coordinating with the client's technical and quality team.
Managing MDR/IVDR deadlines
The MDR and IVDR recertification calendar is a legal obligation with strict deadlines. Dobarro advises on planning the certification process, selecting the Notified Body, and managing the risks of missing deadlines before the AEMPS.
Direct access to the partner
Every file is handled directly by Cristóbal Dobarro Gómez, Doctor of Laws and specialist in administrative law and regulated sectors. No intermediaries, no delegation to juniors.
“The AEMPS notified us of a precautionary withdrawal order for one of our devices. Dobarro reviewed the grounds for the decision, identified procedural defects, and secured suspension of the withdrawal while the appeal was processed. Without that response within the first 48 hours, we would have lost weeks of distribution.”
— Regulatory Director, medical device manufacturer · Spain
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Free ConsultationFrequently asked questions about healthcare, pharmaceutical and food law
What is the MDR Regulation and how does it differ from the former MDD?
Regulation (EU) 2017/745 (MDR) replaced the former MDD Directive 93/42/EEC. It introduces substantially stricter requirements: reclassifying devices (especially software), a heavier technical documentation burden, reinforced post-market surveillance, the UDI traceability system, and the European EUDAMED database. MDD certificates are not indefinitely valid: manufacturers must recertify under the MDR before the deadlines set by Regulation (EU) 2023/607.
When must my medical device be certified under the MDR or IVDR?
The current transition deadlines are: MDR implantable class III and IIb until 31 December 2027; MDR class IIa, non-implantable IIb and class Is/Im/Ir until 31 December 2028. For the IVDR: class D until 31 December 2025 (deadline already passed); class C until 31 December 2026 (imminent deadline); class B and sterile A until 31 December 2027. Manufacturers who do not obtain certification in time will not be able to place the device on the European market and are at risk of having already-distributed products withdrawn.
What is the AEMPS and what sanctioning powers does it have?
The Spanish Agency for Medicines and Medical Devices (AEMPS) is the body responsible for authorising, monitoring and controlling medicines, medical devices and cosmetics in Spain. It can open sanctioning proceedings, order the withdrawal from the market and seizure of products, suspend marketing authorisations, close establishments, and publish safety alerts. Very serious infringements can be fined up to €1,000,000. Its decisions can be appealed before the Ministry of Health and, through judicial review, before the National Court.
What obligations does Regulation (EU) 1169/2011 impose on food labelling?
Regulation (EU) 1169/2011 requires the following mandatory particulars: the food's name, list of ingredients with allergens (Annex II) clearly highlighted, net quantity, best-before or use-by date, storage conditions, the name of the responsible operator, country of origin where its omission could mislead, instructions for use, alcoholic strength (>1.2% vol.), and a nutritional declaration (energy, fat, saturates, carbohydrates, sugars, protein, salt). Non-compliance can lead to sanctioning proceedings before AESAN or the competent region.
What are the consequences of not complying with the MDR? Can my product be withdrawn from the market?
Yes. The AEMPS can order the immediate withdrawal from the market of a device lacking CE marking under the MDR/IVDR once the transition deadlines have passed, or one with deficiencies in essential safety requirements. It can additionally impose fines of up to €1,000,000, seize the products, and publish alerts on EUDAMED. Communicating with the AEMPS from the outset and proactively correcting deviations are decisive in mitigating the impact of interim measures.